PET/CT Scan for Kidney Cancer

(CAIX PET/CT Trial)

Overseen By Taylor McVeigh

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Must not be taking: Antineoplastics, Radionuclides

Disqualifiers: Non-renal malignancy, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 1-2 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how effectively a special type of PET scan using 89Zr-Girentuximab (a radiolabeled antibody) can detect kidney cancer (renal cell carcinoma) that may still be present or has returned after treatment. The study includes two groups: one group will receive the study drug and a PET scan, while the other group will undergo cryoablation and receive a second PET scan afterward. The trial seeks participants who show signs of persistent or recurrent kidney cancer, as indicated by recent medical tests or imaging. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of people.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, if you are on any planned cancer treatments, you may need to pause them during the trial.

What prior data suggests that the 89Zr-Girentuximab PET scan is safe for detecting renal cell carcinoma?

Research has shown that 89Zr-Girentuximab is safe and well-tolerated. One study found that patients did not experience serious side effects after receiving the treatment through an IV, indicating that the treatment is generally safe. For any concerns, discussing them with a healthcare provider can help determine if this trial is suitable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of 89Zr-Girentuximab for kidney cancer because it offers a new approach to detection and evaluation. Unlike the standard imaging techniques like CT or MRI scans, 89Zr-Girentuximab is a radiolabeled antibody that specifically targets carbonic anhydrase IX, a protein often found in clear cell renal cell carcinoma (ccRCC). This targeted approach allows for more precise imaging of cancerous tissues, potentially improving the accuracy of diagnoses and the evaluation of residual or recurrent cancer after treatment. Additionally, this method could enhance the assessment of how well treatments like ablation have worked, offering a clearer picture of a patient's condition.

What evidence suggests that the 89Zr-Girentuximab PET scan is effective for detecting renal cell carcinoma?

Research has shown that 89Zr-Girentuximab PET scans accurately detect clear-cell renal cell carcinoma (ccRCC), a type of kidney cancer. In this trial, participants will be divided into two groups: one with patients who have known or suspected recurrent or residual ccRCC, and the other with patients undergoing ablation for ccRCC. Studies have found that this scan successfully detects cancer that remains or returns after treatment, correctly identifying cancer in most cases, with a positive predictive value of at least 91.7%. Early results suggest it might change how doctors manage small kidney tumors and ccRCC. This scanning method is safe and could be more effective than standard CT scans with contrast dye for detecting recurring kidney cancer. ^{1 6 7 8 9}

Who Is on the Research Team?

Shadi Abdar Esfahani, MD, MPH

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with clear-cell renal cell carcinoma (ccRCC) who have undergone treatment but may still have cancer remaining or recurring. Participants should be suitable for PET scans and cryoablation if needed.

Inclusion Criteria

Written and voluntarily given Informed Consent

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 specific criteria at screening

I am 18 years old or older.

Exclusion Criteria

Serious non-malignant disease that may interfere with the objectives of the program or with the safety or compliance of the subject, as judged by the Investigator

Known hypersensitivity to girentuximab or DFO (desferoxamine)

My kidney tumor is a spread from another cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 89Zr-Girentuximab followed by a PET scan 3-7 days after injection

1-2 weeks

1 visit (in-person)

Standard of Care Treatment

Participants in arm 2 undergo cryoablation followed by a repeat PET scan within 3 days

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• 89Zr-Girentuximab

Trial Overview The study tests if a new type of PET scan using the tracer 89Zr-Girentuximab can detect leftover or returning ccRCC after treatment. One group gets scanned before and after standard care, while another just gets scanned.

How Is the Trial Designed?

Group I: Patients with known or suspected recurrent or residual ccRCC Experimental Treatment 1 Intervention

PET and Histological correlation

Group II: Patients with ccRCC undergoing ablation Experimental Treatment 1 Intervention

PET for evaluation of post-ablative kidney

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Telix Pharmaceuticals, Ltd

Collaborator

Trials

1

Recruited

40+

Citations

1. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00402-9/fulltext

[89Zr]Zr-girentuximab for PET–CT imaging of clear-cell ... Our results suggest that [89Zr]Zr-girentuximab PET–CT has a favourable safety profile and is a highly accurate, non-invasive imaging modality ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39520979/

[89Zr]Zr-girentuximab PET-CT imaging to diagnose ... This imaging technique could be a promising tool that could revolutionize the management of small renal masses (SRMs) and ccRCC.

3. urotoday.com urotoday.com/conference-highlights/aua-2025/aua-2025-kidney-cancer/159982-aua-2025-cost-effectiveness-analysis-of-89zr-girentuximab-pet-ct-tlx250-to-guide-management-of-small-renal-masses.html

Cost-Effectiveness Analysis of 89Zr-Girentuximab PET ... For all evaluable patients, positive and negative predictive values were ≥ 91.7% and ≥ 73.7%, respectively. At the 2025 AUA annual meeting, Dr. Kanabur ...

4. uclahealth.org uclahealth.org/clinical-trials/investigational-scan-89zr-dfo-gmab-petct-compared-contrast

An Investigational Scan (89Zr-DFO-GmAb PET/CT ... 89Zr-DFO-GmAb PET/CT may be safe and effective compared to contrast-enhanced CT in detecting recurrent clear cell renal cell cancer after surgery.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2666634024003829

[89Zr]Zr-girentuximab PET-CT imaging to diagnose ... Viewpoint. [89Zr]Zr-girentuximab PET-CT imaging to diagnose, characterize, and differentiate clear-cell renal cell carcinoma.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8426244/

Phase I study to assess safety, biodistribution and radiation ... In the present study, 89Zr-girentuximab was found to be safe and well tolerated by all patients after intravenous administration. In addition, PET imaging with ...

7. europeanurology.com europeanurology.com/article/S0302-2838(24)02676-9/fulltext

[89Zr]Zr-Girentuximab for PET–CT Imaging of Clear-cell ... The study found that 89 Zr-girentuximab had mean sensitivity of 85.5% (95% confidence interval [CI] 81.5–89.6%) and mean specificity of 87.0% (95% CI 81.0–93.1 ...

8. clinicaltrials.gov clinicaltrials.gov/study/NCT07077083

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

9. urotoday.com urotoday.com/conference-highlights/asco-gu-2023/asco-gu-2023-kidney-cancer/142594-asco-gu-2023-zircon-results-from-phase-3-study-of-89zr-dfo-girentuximab-for-pet-ct-imaging-of-clear-cell-renal-cell-carcinoma.html

ZIRCON: Results from Phase 3 Study of 89Zr-DFO ... The ZIRCON study evaluated the performance of TLX250-CDx PET/CT for the detection of clear cell RCC in adult patients with indeterminate renal masses.