89Zr-girentuximab PET in Urothelial Cancer Patients

Bladder Cancer Clinical Trial

— Zip Up  

Official title:

Zirconium-girentuximab PET in Urothelial Cancer Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05018442
• Other study ID #: Zip01
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 3, 2021
• Est. completion date: May 31, 2022

Study information

• Verified date: August 2021
• Source: Telix International Pty Ltd
• Contact: Dickon Hayne, Prof
• Phone: +61 8 6152 6916
• Email: dickon.hayne[@]uwa.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase Ib/II study will evaluate the use of 89Zr-girentuximab in the staging of urothelial carcinoma. The primary objective of this study is to compare the sensitivity and specificity of 89Zr-girentuximab PET with FDG-PET in the staging of urothelial carcinoma.

Description:

This study will evaluate the use of 89Zr-girentuximab in the staging of urothelial carcinoma. The primary objective of this study is to compare the sensitivity and specificity of 89Zr-girentuximab PET with FDG-PET in the staging of urothelial carcinoma.

The 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: May 31, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Aged 18 years or older

• Able to provide informed consent

• Diagnosed with urothelial carcinoma

Exclusion Criteria:

• Active malignancy other than urothelial carcinoma including clear cell renal cell carcinoma and/or requiring administration of tyrosine kinase inhibitors for 1 month prior to inclusion

• Administration of a radioisotope within 10 physical half-lives prior to study enrolment

• Administration of chemotherapy, radiotherapy, or immunotherapy within 4 weeks prior to planned administration of 89Zr-girentuximab or continuing adverse effects from such therapy

• Planned antineoplastic therapies for the period between administration of 89 Zr-girentuximab and imaging

• Serious non-malignant disease that may interfere with the objectives of the study

• Renal insufficiency with glomerular filtration rate =60ml/min/1.73m2

• Pregnancy or lactation

• Exposure to murine or chimeric antibodies within the last 5 years

• Known hypersensitivity or human anti-chimeric antibodies against girentuximab

Related Conditions & MeSH terms

• Bladder Cancer
• Carcinoma, Transitional Cell
• Urothelial Carcinoma

Intervention

Drug:
• 89Zr-Girentuximab
89Zr-Girentuximab

Locations

Country	Name	City	State
Australia	Fiona Stanley Hospital	Murdoch	Western Australia

Sponsors (1)

Lead Sponsor	Collaborator
Telix International Pty Ltd

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 to Day 90
Secondary	To evaluate the correlation between 89Zr-girentuximab SUVs and degree of urinary carbonic anhydrase IX excretion (cytology and CA-IX via PCR)	89Zr-girentuxumab SUVs will be correlated with urinary CAIX expression	Day 1
Secondary	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	Day 1 to Day 90
Secondary	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	Day 1 to Day 90