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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05046665
Registration number
NCT05046665
Ethics application status
Date submitted
8/09/2021
Date registered
16/09/2021
Titles & IDs
Public title
Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients
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Scientific 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)
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Secondary ID [1]
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ZiPUP
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Universal Trial Number (UTN)
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Trial acronym
ZiPUP
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma
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Condition category
Condition code
Cancer
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Kidney
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Cancer
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Bladder - transitional cell cancer
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - 89Zr-Girentuximab
Other: Administration of 89Zr-Girentuximab - Administration of 89Zr-Girentuximab as per protocol
Treatment: Drugs: 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET
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Assessment method [1]
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Sensitivity and specificity will be established following histological confirmation
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Timepoint [1]
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Day 1 - Day 90
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Secondary outcome [1]
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To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR).
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Assessment method [1]
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89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression
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Timepoint [1]
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Day 1
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Secondary outcome [2]
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Number of participants with treatment related adverse events related to 89Zr-girentuximab administration
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Assessment method [2]
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Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria
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Timepoint [2]
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Day 1 to Day 90
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Secondary outcome [3]
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To quantify the correlation between tumour volume using MIM quantitative software and histopathological findings
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Assessment method [3]
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Tumour burden as defined by volumetric software will be correlated with histopathological results
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Timepoint [3]
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Day 1 - Day 90
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Eligibility
Key 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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key 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
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Study design
Purpose of the study
Diagnosis
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Allocation to intervention
NA
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/05/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
9/08/2022
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Sample size
Target
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Accrual to date
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Final
11
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
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Fiona Stanley Hospital - Murdoch
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Recruitment postcode(s) [1]
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6150 - Murdoch
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Funding & Sponsors
Primary sponsor type
Government body
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Name
South Metropolitan Health Service
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Telix Pharmaceuticals (Innovations) Pty Limited
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05046665
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Trial related presentations / publications
Al-Zubaidi M, Viswambaram P, McCombie S, Liow E, Lenzo N, Ferguson T, Redfern AD, Gauci R, Hayne D. 89Zirconium-labelled girentuximab (89Zr-TLX250) PET in Urothelial Cancer Patients (ZiPUP): protocol for a phase I trial of a novel staging modality for urothelial carcinoma. BMJ Open. 2022 Apr 15;12(4):e060478. doi: 10.1136/bmjopen-2021-060478.
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05046665