CAIX PET/CT for Residual or Recurrent Post-ablative ccRCC
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- 89Zr-Girentuximab
Treatment groups
10 Participants
are divided into 2 treatment groupsSponsors and collaborators
Massachusetts General Hospital
Lead sponsor
Telix Pharmaceuticals (Innovations) Pty Ltd
Collaborator
Source ClinicalTrials.gov