Actively Recruiting
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
Led by Jonsson Comprehensive Cancer Center · Updated on 2025-06-12
91
Participants Needed
1
Research Sites
329 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
This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.
CONDITIONS
Official 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) including tumors with extensive sarcomatoid features if high CAIX expression is present
- Undergone definitive treatment of primary tumor (partial or radical nephrectomy) with or without removal of metastatic disease to no evidence of disease (NED) within 2 years
- Surgery performed between 4 to 16 weeks before planned imaging
- Classified as intermediate-high or high risk of recurrence based on specific tumor stage, grade, nodal involvement, or metastatic status
- Negative pregnancy test for women of childbearing potential within 24 hours before receiving the investigational product
- Consent to use double-barrier contraception until at least 42 days after 89Zr-DFO-GmAb administration
- Ability to remain still and lie flat during imaging lasting less than one hour
You will not qualify if you...
- Unable to provide written informed consent
- Evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
- Prior post-operative imaging already confirming disease status
- Untreated non-renal cancers except low risk prostate cancer on active surveillance or non-melanoma skin cancer
- Prior treated malignancies with recent active treatment for stage III cancers or currently progressing cancers
- Contraindications to iodinated contrast CT agents including severe allergy or low kidney function (GFR ≤ 30 ml/min/1.73m²)
- Use of systemic therapy for kidney cancer or radiotherapy within 4 weeks before enrollment
- Exposure to experimental diagnostic or therapeutic drugs within 14 days before planned administration
- Pregnant or breastfeeding women
- Known allergy to girentuximab
- Inability to remain still and lie flat for imaging procedures lasting about 30 minutes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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