TheranosticTrials.org

Clinical Trial · NCT07077083

CAIX PET/CT for Residual or Recurrent Post-ablative ccRCC

Overview

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.

Sponsor

Massachusetts General Hospital

Phase

Phase 2

Contacts

Taylor McVeigh (CONTACT)

tmcveigh@mgh.harvard.edu

6177261312

Shadi Abdar Esfahani, MD, MPH (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT07077083

Drug / Compound

Girentuximab

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Antibodies
Chelator: DFO

Eligibility

Inclusion

  • 1. Written and voluntarily given Informed Consent
  • 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.
  • Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
  • 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.
  • ≥18 years of age at time of consent a. Because no dosing or adverse event data are currently available on the use of 89Zr-girentuximab in participants \<18 years of age, children are excluded from this study, but will be eligible for future pediatric trials.

Exclusion

  • Active non-renal malignancy requiring therapy during and up to EOT visit.
  • 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.
  • 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.
  • 1. Renal mass known to be a metastasis of another primary tumor.