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A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study) (ZiPUP)

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ClinicalTrials.gov Identifier: NCT05046665
Recruitment Status : Recruiting
First Posted : September 16, 2021
Last Update Posted : September 16, 2021
Sponsor:
Collaborator:
Telix International Pty Ltd
Information provided by (Responsible Party):
South Metropolitan Health Service

Study Description
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Brief Summary:

The aim of this study is to determine if it is practical to use 89Zr-TLX250 PET/CT in the staging and detection of localized and metastatic urothelial carcinoma or bladder cancer.

The primary objective is to evaluate the feasibility of using 89Zr-TLX250 PET/CTas a new diagnostic and staging modality to detect urothelial carcinoma or bladder cancer.


Condition or disease Intervention/treatment Phase
Urothelial Carcinoma Drug: 89Zr-Girentuximab Phase 1

Detailed Description:

This will be a non-randomised, non-blinded, single centre, phase 1 feasibility study comparing 89Zr-girentuximab PET with FDG PET in patients with urothelial carcinoma or bladder cancer. This study would include 2 cohorts of adult patients; those with known metastatic urothelial carcinoma and bladder cancer and those undergoing primary staging for recently diagnosed urothelial carcinoma or bladder cancer.

This study is open-label, single centre and eligible patients will receive a single administration of study drug prior to imaging on day 5 (+/- 2 days). PET scans will be independently interpreted by nuclear medicine physicians blinded to the FDG PET findings. For patients proceeding to radical cystectomy, subsequent histological confirmation of areas of increased uptake will be retrospectively correlated with both PET scans.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Single-centre, Open-label, Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium-labelled Girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP Study)
Actual Study Start Date : May 14, 2021
Estimated Primary Completion Date : March 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Staging cohort
Eligible participants recruited to the staging cohort
 Drug: 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.
Metastatic cohort
Eligible participants recruited from the metastatic cohort
 Drug: 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.


Outcome Measures
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Primary Outcome Measures :
  1. Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET [ Time Frame: Day 1 - Day 90 ]
    Sensitivity and specificity will be established following histological confirmation


Secondary Outcome Measures :
  1. To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR). [ Time Frame: Day 1 ]
    89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression

  2. To evaluate safety parameters related to 89Zr-girentuximab administration [ Time Frame: Day 1 to Day 90 ]
    Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria

  3. To evaluate the correlation between tumour volume using MIM quantitative software and histopathological findings [ Time Frame: Day 1 - Day 90 ]
    Tumour burden as defined by volumetric software will be correlated with histopathological results


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients aged 18 or older with bladder cancer or urothelial carcinoma who are able to provide informed consent
  2. Negative serum pregnancy test in female patients of childbearing potential at screening. Confirmation of negative pregnancy test result from urine within 24 hours prior to receiving investigational product.
  3. Consent to practise double-barrier contraception until a minimum of 42 days after 89Zr-TLX250 administration.

Exclusion Criteria:

  1. Active malignancy other than urothelial carcinoma or bladder cancer
  2. Administration of a radioisotope within 10 physical half-lives prior to study enrolment.
  3. Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-TLX250 or continuing adverse effects from such therapy
  4. Planned antineoplastic therapies for the period between administration of 89Zr-TLX250 and imaging
  5. Serious non-malignant disease that may interfere with the objectives of the study
  6. Renal insufficiency with glomerular filtration rate ≤45 mL/min/1.73m2
  7. Pregnancy or lactation
  8. Exposure to murine or chimeric antibodies within the last 5 years
  9. Known hypersensitivity or human anti-chimeric antibodies against girentuximab
  10. Exposure to any experimental diagnostic or therapeutic drug 30 days prior to the date of planned administration of 89Zr-TLX250
  11. Contraindications to FDG PET/CT
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05046665


Locations
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Australia, Western Australia
Fiona Stanley Hospital Recruiting
Murdoch, Western Australia, Australia, 6150
Contact: Dickon Hayne    61 8 6152 2222    dickon.hayne@uwa.edu.au   
Contact: Cynthia Hawks    61 8 6152 6916    Cynthia.Hawks@health.wa.gov.au   
Sponsors and Collaborators
South Metropolitan Health Service
Telix International Pty Ltd
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: South Metropolitan Health Service
ClinicalTrials.gov Identifier: NCT05046665    
Obsolete Identifiers: NCT05018442
Other Study ID Numbers: ZiPUP
First Posted: September 16, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by South Metropolitan Health Service:
Glandular and Epithelial
Additional relevant MeSH terms:
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Carcinoma, Transitional Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms