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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

Tracking Information
First Submitted Date  ICMJE September 8, 2021
First Posted Date  ICMJE September 16, 2021
Last Update Posted Date September 16, 2021
Actual Study Start Date  ICMJE May 14, 2021
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 8, 2021)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: September 8, 2021)
  • 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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)
Official Title  ICMJE 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)
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.

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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Urothelial Carcinoma
Intervention  ICMJE Drug: 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.
Study Arms  ICMJE
  • Staging cohort
    Eligible participants recruited to the staging cohort
    Intervention: Drug: 89Zr-Girentuximab
  • Metastatic cohort
    Eligible participants recruited from the metastatic cohort
    Intervention: Drug: 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 8, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2022
Estimated Primary Completion Date March 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Listed Location Countries  ICMJE Australia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05046665
Other Study ID Numbers  ICMJE ZiPUP
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party South Metropolitan Health Service
Study Sponsor  ICMJE South Metropolitan Health Service
Collaborators  ICMJE Telix International Pty Ltd
Investigators  ICMJE Not Provided
PRS Account South Metropolitan Health Service
Verification Date September 2021

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