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

Launched by MASSACHUSETTS GENERAL HOSPITAL · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a special type of scan called an 89Zr-Girentuximab PET scan to see if it can help detect kidney cancer (specifically clear cell renal cell carcinoma) that remains or comes back after treatment. The researchers want to find out if this scan can better identify cancer that might be missed by other tests and how the scan images change before and after standard treatment, which includes a procedure called cryoablation (freezing the tumor to destroy it).

People 18 years and older who have signs of kidney cancer that may still be present or has returned after initial treatment could be eligible to join. Participants will receive an injection of the study drug and then have a PET scan a few days later. Some will go on to have cryoablation treatment and then get a second PET scan within a few days after that to see how the treatment affected the cancer. Women who can become pregnant will need to have a pregnancy test and use birth control for a period after receiving the study drug. The trial is not yet recruiting, but if you have had kidney cancer and meet these criteria, this study may offer a new way to monitor your condition more closely.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Written and voluntarily given Informed Consent
• • 2. ≥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.
• • 3. Have the capacity to understand the study and be willing and able to comply with all protocol requirements.
• • 4. 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.
• • 5. 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.
• 6. 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:
• • 1. Post-menopausal defined as aged more than 50 years and amenorrheic for at least 12 months following cessation of all exogenous hormonal treatments
• • 2. 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
• • 3. Documentation of irreversible surgical sterilization by hysterectomy, bilateral oophorectomy, or bilateral salpingectomy but not tubal ligation
• • 7. For all participants, consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-girentuximab administration.
• Exclusion Criteria:
• • 1. Renal mass known to be a metastasis of another primary tumor.
• • 2. Active non-renal malignancy requiring therapy during and up to EOT visit.
• • 3. Planned antineoplastic therapies (for the period between IV administration of 89Zr-girentuximab and imaging).
• • 4. Previous administration of any radionuclide within 10 of its half-lives before 89Zr-girentuximab injection day.
• • 5. 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.
• • 6. Mental impairment that may compromise the ability to give informed consent and comply with the requirements of the program.
• • 7. Women who are pregnant or breastfeeding.
• • 8. Known hypersensitivity to girentuximab or DFO (desferoxamine).
• • 9. Renal insufficiency with estimated glomerular filtration rate eGFR ≤ 40 mL/min/ 1.73 m²