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89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study (89ZR-TLX250)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03849118
Recruitment Status : Active, not recruiting
First Posted : February 21, 2019
Last Update Posted : November 10, 2022
Sponsor:
Information provided by (Responsible Party):
Telix International Pty Ltd

Tracking Information
First Submitted Date  ICMJE January 29, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date November 10, 2022
Actual Study Start Date  ICMJE August 15, 2019
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 8, 2022)
To evaluate sensitivity and specificity of qualitative assessment of PET/CT imaging with 89Zr-TLX250 to noninvasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Histological confirmation from nephrectomy material will serve as standard of truth. ]
This outcome will be evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This will be compared against the histological determination of the lesion type following resection of the lesion
Original Primary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
To evaluate sensitivity and specificity of PET/CT imaging with 89Zr-TLX250 to non-invasively detect ccRCC in patients with indeterminate renal masses, using histology as standard of truth [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Histological confirmation from nephrectomy material will serve as standard of truth. ]
This outcome will be evaluated on all patients by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This will be compared against the histological determination of the lesion type following resection of the lesion
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2022)
  • To determine sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a) [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
  • To determine specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 4 cm in largest diameter (cT1a) [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 4cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
  • To evaluate positive predictive value (PPV), and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses, and in patients with indeterminate renal masses of ≤ 4 cm (cT1a). [ Time Frame: This analysis will be conducted after all patients have completed study involvement ]
    This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
  • To define a standardized uptake value (SUV) cut-off for 89Zr-girentuximab, suitable to discriminate ccRCC from non-ccRCC [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab ]
    This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue in order to see if there is a mathematical way to derive the tumour type information from the imaging alone. The tumour type will be determined by the histological sample obtained following resection.
  • To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological carbonic anhydrase IX (CAIX) expression [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab ]
    This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
  • To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers [ Time Frame: This analysis will be conducted through study completion, on average of 5 months ]
    This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
  • To evaluate intra-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images [ Time Frame: This analysis will be conducted through study completion, on average of 5 months ]
    This outcome will be conducted on a randomly determined subset of 10% of the patients. Three readers blinded to the histological outcome will be asked to read each patient PET/CT image on two occasions and determine if the target lesion is positive for Zr89. The results will be evaluated as a percent figure to consistently report the same finding with each patient.
  • To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab. [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
  • To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab. [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
  • To evaluate negative predictive value (NPV) and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses [ Time Frame: This analysis will be conducted through study completion, on average 5 months ]
    This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
  • To evaluate safety parameter related to Liver function in patients administered with 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
  • To evaluate safety parameter related to Renal function in patients administered with 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
  • To evaluate safety parameter related to Full Blood Count in patients administered with 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
  • To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a Bosniak 3 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate sensitivity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a Bosniak 4 lesion by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 3 cm lesions [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 3 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with IRMs ≤ 2 cm. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 2 cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 3 lesions. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a Bosniak 3 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
  • To evaluate specificity of 89Zr-TLX250 PET/CT imaging to detect ccRCC in patients with Bosniak 4 lesions. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a Bosniak 4 by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 19, 2019)
  • To evaluate sensitivity and specificity of 89Zr-girentuximab PET/CT imaging to detect ccRCC in the subgroup of patients with indeterminate renal masses of ≤ 2cm in largest diameter using histology as standard of truth [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab. ]
    This outcome will be evaluated on all patients with a lesion ≤ 2cm in largest diameter by using a PET/CT machine to determine the uptake of the Zr89 radiotracer within the renal lesion. This amount of uptake in the lesion will be compared with the histologically determined cancer type following resection of the lesion
  • To evaluate positive predictive value PPV, and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses [ Time Frame: This analysis will be conducted after all patients have completed study involvement ]
    This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
  • To define a standardized uptake value (SUV) cut-off for 89Zr-girentuximab, suitable to discriminate ccRCC from non-ccRCC [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab ]
    This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue in order to see if there is a mathematical way to derive the tumour type information from the imaging alone. The tumour type will be determined by the histological sample obtained following resection.
  • To evaluate the correlation between 89Zr- girentuximab SUVs and degree of histological CAIX expression [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab ]
    This outcome will be assessed on all patients. The counts derived from the PET/CT imaging of the renal lesion will be compared with the amount of CAIX expressed in the histologically extracted sample
  • To evaluate inter-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images, when performed by multiple readers [ Time Frame: This analysis will be conducted through study completion, on average of 5 months ]
    This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if the target lesion is positive for Zr89. A comparison of findings will then be made between the readers for each patient individually.
  • To evaluate intra-reader variability of diagnostic assessments of 89Zr- girentuximab PET/CT images [ Time Frame: This analysis will be conducted through study completion, on average of 5 months ]
    This outcome will be conducted on a randomly determined subset of 10% of the patients. Three readers blinded to the histological outcome will be asked to read each patient PET/CT image on two occasions and determine if the target lesion is positive for Zr89. The results will be evaluated as a percent figure to consistently report the same finding with each patient.
  • To evaluate safety parameter of Heart rate in patients administered with 89Zr-girentuximab. [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured as beats per minute on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
  • To evaluate safety parameter of blood pressure in patients administered with 89Zr-girentuximab. [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured as mmHg on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria
  • To evaluate negative predictive value NPV and accuracy of 89Zr-girentuximab PET/CT imaging to detect ccRCC in patients with indeterminate solid renal masses [ Time Frame: This analysis will be conducted through study completion, on average 5 months ]
    This outcome will be determining the proportion (as a percent) of the whole study population in which the PET/CT imaging could correctly predict if an individual patient had clear cell renal cell carcinoma or can correctly predict if the patient did not have clear cell renal cell carcinoma
  • To evaluate safety parameter related to Liver function in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
  • To evaluate safety parameter related to Renal function in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
  • To evaluate safety parameter related to Full Blood Count in patients administered 89Zr-girentuximab [ Time Frame: Patients will be evaluated for the 90 day period following administration of 89Zr-girentuximab ]
    This outcome will be measured on all patients with treatment-related adverse events based on criteria as determined by the NCI CTCAE v 5.0 criteria. Results will be assessed by number of participants with abnormal laboratory values.
Current Other Pre-specified Outcome Measures
 (submitted: November 8, 2022)
  • To quantitatively estimate achievable radiation absorbed doses (Gy) for therapeutic 177 Lutetium-girentuximab based on single time point 89Zr-girentuximab PET/CT images. [ Time Frame: This analysis will be conducted after all patients have completed study involvement, an average of 1 year ]
    This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
  • To quantitatively estimate achievable tumour uptake, retention and radiation absorbed doses (Gy) for therapeutic 177Lu-girentuximab, based on a general model of average girentuximab tumour kinetics derived from serial 89Zr-girentuximab imaging. [ Time Frame: This analysis will be conducted after all patients have completed study involvement, an average of 1 year ]
    This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
  • To quantitatively estimate achievable tumour uptake, retention and radiation absorbed doses (Gy) for therapeutic 177Lu-girentuximab, based on an assumed specific activity of 177Lu-girentuximab. [ Time Frame: This analysis will be conducted after all patients have completed study involvement, an average of 1 year ]
    This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
  • To evaluate the correlation between 89Zr-TLX250 SUVs and degree of histological CAIX expression. [ Time Frame: Single diagnostic administration, followed by a diagnostic scan on Day 5 ± 2 days. Resection to be conducted within 90 days of administration of 89Zr-girentuximab ]
    This outcome will be conducted on the whole study population and will use the counts derived from the PET/CT imaging of the 89Zr in the target tissue and compare it to the CAIX expression determined by the histological sample obtained following resection.
  • To evaluate distant masses outside the kidney identified on 89Zr-TLX250 whole body PET/CT in patients who present with unexpected evidence of disseminated disease. [ Time Frame: This analysis will be conducted after all patients have completed study involvement ]
    This outcome will be conducted on all patients. Three blinded readers operating independently will be used to read each patient PET/CT image and determine if there is evidence of disseminated disease with Zr89 which was not previously known.
Original Other Pre-specified Outcome Measures
 (submitted: February 19, 2019)
To quantitatively estimate achievable radiation absorbed doses (Gy) for therapeutic 177 Lu-girentuximab based on single time point 89Zr-girentuximab PET/CT images [ Time Frame: This analysis will be conducted after all patients have completed study involvement, an average of 1 year ]
This outcome will be assessed by determining the radiation absorbed dose, using Monte Carlo analysis, that would have been delivered to the target tissue had the girentuximab been bound alternatively with the therapeutic radionuclide 177Lu, rather than the diagnostic 89Zr label.
 
Descriptive Information
Brief Title  ICMJE 89Zr-TLX250 for PET/CT Imaging of ccRCC- ZIRCON Study
Official Title  ICMJE A Confirmatory, Prospective, Open-label, Multi-centre Phase 3 Study to Evaluate Diagnostic Performance of Zirconium-labelled Girentuximab to Non-invasively Detect ccRCC by PET/CT Imaging in Patients With Indeterminate Renal Masses
Brief Summary 89Zr-TLX250 is under clinical development as a diagnostic agent targeting clear cell renal cell carcinoma.
Detailed Description

This is a confirmatory, prospective, open-label, multi-centre phase 3 study to evaluate sensitivity and specificity of 89Zr-TLX250 Positron Emission Tomography/Computed Tomography (PET/CT) imaging to non-invasively detect clear cell renal cell cancer (ccRCC) in adult patients with indeterminate renal masses (IRM), scheduled for partial or total nephrectomy.

Patients, will be recruited in 12-15 renal cancer care specialist centres, who have access to state-of-the-art PET/CT imaging equipment.

The study involves a single administration of 89Zr-TLX250. Imaging will then be conducted 5 +/-2 days post administration. The partial/total nephrectomy will then be performed at institutional discretion any time following the PET/CT imaging visit, but no later than 90 days post administration of 89Zr-TLX250. Histological tumour samples will be prepared and used for histological diagnosis of the renal mass (ccRCC or non-ccRCC) read by a central laboratory.

On Day 5 +/-2 post study drug administration, an abdominal PET/CT imaging will be obtained. In patients, in which unexpected evidence for disseminated disease is observed, PET/CT imaging may be extended to complete whole body imaging(vertex of skull to toe) at the discretion of the investigator.

Image data analyses will be performed by a central image core lab. Qualitative visual analysis (presence or absence of localised 89Zr-TLX250 uptake inside or in vicinity of renal lesion, as seen on contrast-enhanced CT or MRI), will be used to assess test performance or 89Zr-TLX-250 PET/CT imaging to non-invasively detect ccRCC, using histological results from the central histological reference laboratory as standard of truth.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
diagnostic, confirmatory, prospective, multi-centre
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Clear Cell Renal Cell Carcinoma
Intervention  ICMJE Diagnostic Test: 89Zr-girentuximab
Single IV administration on Day 0, followed by diagnostic scan on Day 5 +/- 2 days.
Other Names:
  • 89Zr-TLX250
  • 89Zr-DFO-TFP-girentuximab (GTX)
Study Arms  ICMJE Experimental: 89Zr-girentuximab
A single administration of 37 Megabecquerel (MBq) (±10%) 89Zr-girentuximab, containing a mass dose of 10 mg of girentuximab, followed by a diagnostic scan on Day 5 ± 2 days after administration.
Intervention: Diagnostic Test: 89Zr-girentuximab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: February 19, 2019)
252
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 30, 2023
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Written and voluntarily given Informed Consent
  2. Male or female ≥18 years of age
  3. Imaging evidence of a single indeterminate renal mass of ≤7cm in largest diameter (tumour stage cT1) , on CT or MRI with and without contrast agent, suspicious for ccRCC
  4. Scheduled for lesion resection as part of regular diagnostic work-up within 90 days from planned 89Zr-TLX250 administration
  5. Negative serum pregnancy tests in female patients of childbearing potential (at Screening and within 24 hours prior to receiving investigational product)
  6. for patients included in France only, verification and confirmation of their affiliation with a social security
  7. Sufficient life expectancy to justify nephrectomy
  8. Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration

Exclusion Criteria:

  1. Bioptic procedure (rather than a partial or total nephrectomy) planned for histological species delineation of IRM
  2. Renal mass known to be a metastasis of another primary tumour
  3. Active non-renal malignancy requiring therapy during the time frame of the study participation
  4. Chemotherapy, radiotherapy or immunotherapy within 4 weeks prior to the planned administration of 89Zr-TLX250 or continuing adverse effects (> grade 1) from such therapy (Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)
  5. Planned antineoplastic therapies (for the period between administration of 89 Zr-TLX250 and imaging)
  6. Exposure to murine or chimeric antibodies within the last 5 years
  7. Previous administration of any radionuclide within 10 half-lives of the same
  8. Serious non-malignant disease (e.g. psychiatric, infectious, autoimmune or metabolic) that may interfere with the objectives of the study or within the safety of compliance of the subjects as judged by the Investigator
  9. Mental impairment that may compromise the ability to give Informed Consent and comply with the requirements of the study
  10. Exposure to any experimental diagnostic or therapeutic drug within 30 days from the date of planned administration of 89Zr-TLX250
  11. Women who are pregnant or breastfeeding
  12. Known hypersensitivity to Girentuximab or DFO (Desferrioxamine)
  13. Renal insufficiency with glomerular filtration rate (GFR) ≤ 60 millilitres/min/1.73m2
  14. Vulnerable patients (e.g being in detention)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Canada,   France,   Netherlands,   Turkey,   United States
Removed Location Countries Spain,   United Kingdom
 
Administrative Information
NCT Number  ICMJE NCT03849118
Other Study ID Numbers  ICMJE 89Zr-TLX250-003
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Telix International Pty Ltd
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Telix International Pty Ltd
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Howard Gurney, MD Macquarie University Hospital
Principal Investigator: Francoise Brodere, MD University Hospital ICO, Nantes, France
Principal Investigator: Peter Mulders, MD Radboud University Medical Center
Principal Investigator: Marcel Stokkel, MD The Netherlands Cancer Institute
Principal Investigator: Declan Murphy, MD Victorian Comprehensive Cancer Centre
Principal Investigator: Andrew Scott, MD Olivia Newton John Cancer Research Center, Austin Hospital
Principal Investigator: Simon Wood, MD Princess Alexander Hospital
Principal Investigator: Mark Frydenberg, MD Cabrini Hospital
Principal Investigator: David Chan Royal North Shore Hospital
Principal Investigator: Jean-Christophe Bernhard, MD CHU de Bordeaux, Groupe Hospitalier Pellegrin
Principal Investigator: Pierre Olivier, MD CHRU de Nancy - Hôpitaux de Brabois
Principal Investigator: Linda Heijmen, MD Leiden University Medical Centre
Principal Investigator: Martin Geert Steffens, MD Isala
Principal Investigator: Karolien Goffin, MD Universitair Ziekenhuis Leuven
Principal Investigator: Carlos Artigas Guix, MD Instutit Jules Bordet
Principal Investigator: Nicolas Lumen, MD Universitair Ziekenhuis Gent
Principal Investigator: Sumer Baltaci, MD Ankara University
Principal Investigator: Bulent Akdogan, MD Ankara Hacettepe University
Principal Investigator: Bulent Onal, MD Istanbul University - Cerrahpasa (IUC)
Principal Investigator: Tamer Aksoy, MD Istanbul Training and Research Hospital
PRS Account Telix International Pty Ltd
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP