Actively Recruiting
89Zr-DFO-GmAb PET/CT vs Contrast-Enhanced CT for Detection of Recurrent Clear Cell Renal Cell Carcinoma After Surgery
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-06-12
91
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
J
Jonsson Comprehensive Cancer Center
Lead Sponsor
T
Telix Pharmaceuticals (Innovations) Pty Limited
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a new imaging scan called 89Zr-DFO-GmAb PET/CT to detect the return of clear cell renal cell cancer after surgery. This phase II trial compares this investigational PET/CT scan to the standard contrast-enhanced CT scan. The study aims to see if the new scan can better detect small or hidden cancer spots that standard CT might miss, especially in patients at high risk of cancer returning after surgery. Participants receive an intravenous injection of 89Zr-DFO-girentuximab, a radioactive antibody that attaches to cancer cells, on the first day. Seven days later, they undergo a whole-body PET/CT scan and a contrast-enhanced CT scan. Additional tests like bone scans or brain imaging may be done if needed. Blood samples are also collected during the study. During the study, participants are followed for up to 24 months with visits at 8, 16, and 24 months to monitor outcomes. Researchers assess how well the scans detect cancer lesions, the safety of the new scan, recurrence-free survival, and how scan results affect treatment decisions. They also study tumor markers and circulating tumor DNA to understand disease status. Safety and adverse events are tracked up to 14 days after scanning.
CONDITIONS
Brief Title
An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Histologically confirmed clear cell renal cell carcinoma (ccRCC) based on surgery samples
- For tumors with extensive sarcomatoid features, evidence of clear cell areas with high CAIX expression
- Completed surgery to remove primary tumor and any metastatic disease with no evidence of disease
- Surgery performed between 4 and 16 weeks before planned imaging
- High risk of recurrence based on defined tumor staging and pathology criteria
- Negative pregnancy test for women of childbearing potential within 24 hours before investigational product
- Consent to use double-barrier contraception for at least 42 days after 89Zr-DFO-GmAb administration
- Ability to remain still and lie flat for under 1 hour during imaging
You will not qualify if you...
- Unable to provide written informed consent
- Evidence of remaining disease or metastasis at planned 89Zr-DFO-GmAb administration
- Prior post-operative imaging confirming disease status
- Untreated non-renal cancers except low-risk prostate or non-melanoma skin cancer
- Prior treated cancers with certain recent treatments or progression
- Contraindications to iodinated contrast-enhanced CT agents including severe allergy or low kidney function
- Recent systemic therapy or radiotherapy for kidney cancer within 4 weeks
- Exposure to experimental drugs within 14 days before planned administration
- Pregnancy or breastfeeding
- Known allergy to girentuximab
- Inability to lie still and flat during imaging procedure (about 30 minutes)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days from injection
Participants receive an intravenous injection of 89Zr-DFO-GmAb and undergo whole body PET/CT and contrast-enhanced CT scans to detect recurrent clear cell renal cell cancer after surgery. Additional imaging such as bone scans and brain MRI or CT may be performed if clinically indicated. Blood samples are also collected during the study.
2 visits (in-person)
Duration - Up to 24 months
Participants are followed up to monitor recurrence-free survival and safety after the diagnostic evaluation.
Follow-up visits at 8, 16, and 24 months
Trial Site Locations
Total: 1 location
1
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, United States, 90095
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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