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| Name | Class |
|---|---|
| Telix Pharmaceuticals (Innovations) Pty Ltd | INDUSTRY |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with known or suspected recurrent or residual ccRCC | Experimental | PET and Histological correlation |
|
| Patients with ccRCC undergoing ablation | Experimental | PET for evaluation of post-ablative kidney |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 89Zr-Girentuximab | Drug | 89Zr-Girentuximab PET |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 0-3 days after SOC cryoablation |
| 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. | From enrollment to 0-3 days after SOC cryoablation |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline through 0-3 days days after SOC cryoablation |
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Inclusion Criteria:
Written and voluntarily given Informed Consent
≥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.
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:
For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Taylor McVeigh | Contact | 6177261312 | tmcveigh@mgh.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Shadi Abdar Esfahani, MD, MPH | Massachusetts General Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
The information on patient demographics, cancer (ccRCC) history, imaging findings, and histological assessment will be shared in scientific presentations and publications.
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| ID | Term |
|---|---|
| D002292 | Carcinoma, Renal Cell |
| D007680 | Kidney Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| 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. | Baseline through 0-3 days after SOC cryoablation |
| D009369 | Neoplasms |
| D014571 | Urologic Neoplasms |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052801 | Male Urogenital Diseases |