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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
89Zr-Girentuximab
Drug89Zr-Girentuximab PET
Treatment groups
10 Participants
are divided into 2 treatment groupsGroup A: Patients with known or suspected recurrent or residual ccRCCExperimental treatment 1 intervention
Group B: Patients with ccRCC undergoing ablationExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
SUVmean of the ablated zone and adjacent or contralateral uninvolved kidney
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmean of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the mean SUVmean and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
Time frame
From enrollment to 0-3 days after SOC cryoablation2
SUVmax of the ablated zone and adjacent or contralateral uninvolved kidney
Qualitative and quantitative assessment of 89Zr-girentuximab probe uptake of the ablative zone in the kidney will be performed. Guided by the findings of standard CT or MRI, a region of interest (ROI) will be drawn over the ablation zone and adjacent uninvolved kidney. SUVmax of the ROIs will be measured for the recurrent/residual tumor and the adjacent or contralateral normal kidney. Descriptive statistics including the SUVmax and standard deviation will be reported for each ROI. Tumor to kidney uptake ratio will also be calculated. It is expected that the recurrent/residual tumor will show uptake above the uninvolved kidney.
Time frame
From enrollment to 0-3 days after SOC cryoablationSecondary outcomes
1
Comparison of SUVmean on pre- and post-ablation scans
Guided by the standard CT or MRI, an ROI will be defined over the primary kidney tumor and adjacent uninvolved kidney on the scans before and after cryoablation. SUVmean as well as tumor to kidney ratio will be calculated on the pre- and post-ablation scans to evaluate whether the uptake decreases immediately after ablation.
Time frame
Baseline through 0-3 days days after SOC cryoablation2
Comparison of SUVmax on pre- and post-ablation scans
Guided by the standard CT or MRI, an ROI will be defined over the primary kidney tumor and adjacent uninvolved kidney on the scans before and after cryoablation. SUVmax as well as tumor to kidney ratio will be calculated on the pre- and post-ablation scans to evaluate whether the uptake decreases immediately after ablation.
Time frame
Baseline through 0-3 days after SOC cryoablationSponsors and contacts
Click on the lead sponsor to view all of their trials.
Massachusetts General Hospital
Lead sponsor
Telix Pharmaceuticals (Innovations) Pty Ltd
Collaborator
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: