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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT05046665




Registration number
NCT05046665
Ethics application status
Date submitted
8/09/2021
Date registered
16/09/2021
Date last updated
16/09/2021

Titles & IDs
Public 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)
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)
Secondary ID [1] 0 0
ZiPUP
Universal Trial Number (UTN)
Trial acronym
ZiPUP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Urothelial Carcinoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Kidney
Cancer 0 0 0 0
Bladder - transitional cell cancer

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - 89Zr-Girentuximab

Other: Staging cohort - Eligible participants recruited to the staging cohort

Other: Metastatic cohort - Eligible participants recruited from the metastatic cohort


Treatment: Drugs: 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET - Sensitivity and specificity will be established following histological confirmation
Timepoint [1] 0 0
Day 1 - Day 90
Secondary outcome [1] 0 0
To evaluate the correlation between 89Zr-girentuximab SUV's and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR). - 89Zr-girentuximab SUV's will be correlated with urinary CA-IX expression
Timepoint [1] 0 0
Day 1
Secondary outcome [2] 0 0
To evaluate safety parameters related to 89Zr-girentuximab administration - Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria
Timepoint [2] 0 0
Day 1 to Day 90
Secondary outcome [3] 0 0
To evaluate the correlation between tumour volume using MIM quantitative software and histopathological findings - Tumour burden as defined by volumetric software will be correlated with histopathological results
Timepoint [3] 0 0
Day 1 - Day 90

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.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 0 0
Fiona Stanley Hospital - Murdoch
Recruitment postcode(s) [1] 0 0
6150 - Murdoch

Funding & Sponsors
Primary sponsor type
Other
Name
South Metropolitan Health Service
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Telix International Pty Ltd
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/show/NCT05046665
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05046665