Phase I Study to Evaluate the Diagnostic Performance of 89Zirconium Girentuximab PET in Urothelial Cancer Patients

Urothelial Carcinoma Clinical Trial

— ZiPUP  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05046665
• Other study ID #: ZiPUP
• Status: Completed
• Phase: Phase 1
• Start date: May 14, 2021
• Est. completion date: August 9, 2022

Study information

• Verified date: April 2024
• Source: South Metropolitan Health Service
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT05018442

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 9, 2022
• Est. primary completion date: August 9, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• 89Zr-Girentuximab
Administration of 89Zr-girentuximab as per protocol.

Locations

Country	Name	City	State
Australia	Fiona Stanley Hospital	Murdoch	Western Australia

Sponsors (2)

Lead Sponsor	Collaborator
South Metropolitan Health Service	Telix Pharmaceuticals (Innovations) Pty Limited

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of the sensitivity and specificity of 89Zr-girentuximab PET with FDG PET	Sensitivity and specificity will be established following histological confirmation	Day 1 - Day 90
Secondary	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	Day 1
Secondary	Number of participants with treatment related adverse events related to 89Zr-girentuximab administration	Number of participants with treatment-related adverse events as assessed by NCI-CTCAE v 5.0 criteria	Day 1 to Day 90
Secondary	To quantify 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	Day 1 - Day 90