CAIX PET/CT for Residual or Recurrent Post-ablative ccRCC (NCT07077083) | Clinical Trial Compass
Not Yet RecruitingPhase 2
CAIX PET/CT for Residual or Recurrent Post-ablative ccRCC
United States10 participantsStarted 2026-03-16
Plain-language summary
The goal of this clinical trial is to learn whether 89Zr-Girentuximab PET scans can inform management of renal cell carcinoma. The main questions it aims to answer are:
* Does the 89Zr-Girentuximab PET detect ccRCC that is left behind or has come back after treatment?
* What differences can be seen on the 89Zr-Girentuximab PET before and after standard of care treatment?
Participants in arm 1 will be given the study drug followed by a PET scan 3-7 days after injection. Participants in arm 2 will receive the same, but will proceed with their standard of care cryoablation after the initial PET scan. Within 3 days of the cryoablation treatment, participants will receive a repeat PET scan.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Written and voluntarily given Informed Consent
. ≥18 years of age at time of consent
. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
. Findings suspicious for post-ablation residual or recurrent ccRCC (subjects in cohort 1) documented at conventional imaging or biopsy, performed within 90 days prior to 89Zr-girentuximab PET scan.
. Findings suspicious for primary ccRCC (subjects in cohort 2) documented at standard histology or conventional imaging, performed within 90 days prior to 89Zr-girentuximab PET scan.
. Negative serum or urine pregnancy tests in female patients of childbearing potential within 72 hours prior to receiving 89Zr-girentuximab. Female patients of non-child bearing potential must provide evidence by fulfilling one of the following criteria at screening:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
Timeframe: From enrollment to 0-3 days after SOC cryoablation
2
SUVmax of the ablated zone and adjacent or contralateral uninvolved kidney
Timeframe: From enrollment to 0-3 days after SOC cryoablation
. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
. Women under 50 years old would be consider postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and with luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels in the post-menopausal range for the institution
Exclusion criteria
. Renal mass known to be a metastasis of another primary tumor.
. Active non-renal malignancy requiring therapy during and up to EOT visit.
. Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).
. Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.
. Serious non-malignant disease (e.g., psychiatric, infectious, autoimmune, or metabolic), that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator.
. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
. Women who are pregnant or breastfeeding.
. Known hypersensitivity to girentuximab or DFO (desferoxamine).