An Investigational Scan (89Zr-DFO-GmAb PET/CT) Compared to Contrast-Enhanced CT for the Detection of Recurrent Clear Cell Renal Cell Cancer After Surgery Comparing Carbonic Anhydrase IX (CAIX) PET CT to Conventional PET CT for Post-Op Staging in Kidney Cancer

NCT06447103 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 23-001576NCI-2024-01928
• Study Type: interventional
• Target: 91
• Locations: 1 country
• Sites: 1

Brief Summary

This phase II trial compares the safety and effectiveness of 89Zr-DFO-GmAb positron emission tomography (PET)/computed tomography (CT) compared to contrast-enhanced CT after surgery in detecting clear cell renal cell cancer that has come back (recurrent). For some patients, the risk of recurrence after surgery remains high. Conventional CT methods, such as contrast-enhanced CT, may not detect small volume or micrometastatic disease. PET/CT with radiotracers, such as 89Zr-DFO-GmAb, may improve detection of tumor cells. Girentuximab (GmAb), a monoclonal antibody, is tagged with zirconium-89, a radioactive atom (which is also known as an isotope). The zirconium-89 (89Zr) isotope is attached to girentuximab with desferrioxamine (DFO) and this combined product is called 89Zr-DFO-girentuximab. 89Zr-DFO-girentuximab attaches itself to a protein on the surface of clear cell renal cell tumor cells called CAIX. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 89Zr-DFO-GmAb. Because some cancers, including clear cell renal cell cancer, take up 89Zr-DFO-GmAb it can be seen with PET. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. Using contrast agents with CT scan to enhance the images (contrast-enhanced CT) is standard of care imaging. 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.

Conditions

Clear Cell Renal Cell Carcinoma; Sarcomatoid Renal Cell Carcinoma; Stage II Renal Cell Cancer; Stage III Renal Cell Cancer; Stage IV Renal Cell Cancer

Keywords

Renal

Outcome Measures

Primary Outcomes (1)

• Lesion detection rate

  Patients will be treated as binary categorization as follows: (i) Patients who have ≥ 1 lesion confirmed to be recurrent disease will be designated positive (recurrence). (ii) Patients with no lesions detected will be designated negative (no recurrence). The analysis of the primary objective will utilize McNemar's test to compare the detection rate between the imaging techniques.

  Up to 16 weeks from surgical resection

Secondary Outcomes (4)

• Incidence of adverse events (AEs)

  Up to day 14

• Positive predictive value (PPV)

  Up to 2 years

• Recurrence-free survival

  Up to 2 years

• Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)

  At baseline and up to 2 years

Study Arms (1)

Diagnostic (89Zr-DFO-GmAb PET/CT)

EXPERIMENTAL

Patients receive 89Zr-DFO-GmAb IV over 3 minutes on day 0 then undergo whole body PET/CT and SOC diagnostic contrast-enhanced CT scan on day 7. Patients also blood sample collection on study. In addition, patients may undergo bone scan and CT or MRI of the brain on study as clinically indicated.

Procedure: Biospecimen Collection; Procedure: Bone Scan; Procedure: Computed Tomography; Procedure: Magnetic Resonance Imaging; Procedure: Positron Emission Tomography; Other: Questionnaire Administration; Drug: Zirconium Zr 89 Girentuximab

Interventions

Biospecimen Collection PROCEDURE

Undergo blood sample collection

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Diagnostic (89Zr-DFO-GmAb PET/CT)

Bone Scan PROCEDURE

Undergo bone scan

Also known as: Bone Scintigraphy

Diagnostic (89Zr-DFO-GmAb PET/CT)

Computed Tomography PROCEDURE

Undergo CT, PET/CT, and CT of the brain

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Diagnostic (89Zr-DFO-GmAb PET/CT)

Magnetic Resonance Imaging PROCEDURE

Undergo MRI of the brain

Also known as: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Diagnostic (89Zr-DFO-GmAb PET/CT)

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Diagnostic (89Zr-DFO-GmAb PET/CT)

Questionnaire Administration OTHER

Ancillary studies

Diagnostic (89Zr-DFO-GmAb PET/CT)

Zirconium Zr 89 Girentuximab DRUG

Given IV

Also known as: 89Zr-DFO-TFP-girentuximab, 89Zr-girentuximab, 89Zr-TLX250, Zirconium Zr 89 cG250, Zirconium Zr 89-TLX250

Diagnostic (89Zr-DFO-GmAb PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18
• Histologically confirmed clear cell renal cell carcinoma (RCC) (ccRCC) (based on partial/radical nephrectomy/metastasectomy)
• For tumors with extensive sarcomatoid features, if there is evidence of areas of clear cell and high CAIX expression throughout the tumor on immunohistochemistry, they will be allowed on study
• Subjects must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no evidence of disease (NED) with a prior nephrectomy \< 2 years)
• Surgery must have been performed between 4-16 weeks at the time of planned imaging
• Subjects are considered to have a high risk of recurrence based on the following criteria:
• Intermediate-high risk ccRCC:
• pathologic tumor stage 2 (pT2), grade 4, or sarcomatoid, N0, M0
• pathologic tumor stage 3 (pT3), any grade, N0, M0
• High risk ccRCC:
• pathologic tumor stage 4 (pT4), any grade, N0, M0
• pT any stage, any grade, number of positive nodes (pN+), M0
• M1 now NED: pathologically-confirmed ccRCC, undergoing a resection of a solitary, isolated soft tissue metastasis within two years from initial nephrectomy
• Negative serum pregnancy tests in female patients of childbearing potential. (Women of child bearing potential \[WOCBP\] require a negative pregnancy test within 24 hours (urine) prior to receiving investigational product)
• Consent to practice double-barrier contraception until a minimum of 42 days after 89Zr-DFO-GmAb administration

You may not qualify if:

• Inability to provide written informed consent
• Any evidence of residual disease or known metastasis at the time of planned 89Zr-DFO-GmAb administration
• Prior post-operative imaging for confirmation of disease status
• An untreated non-renal malignancy with the following exceptions:
• Low risk prostate cancer on active surveillance (National Comprehensive Cancer Network \[NCCN\] very low/low risk)
• Non-melanoma skin cancer
• Any prior treated malignancy meeting the following characteristics:
• Treated stage I or II cancer from which the patient is currently in complete remission
• A stage III cancer from which the patient is progressing or has been disease-free for and has required active treatment (e.g. adjuvant or maintenance therapy) within the past 3 years prior to enrollment
• A hematologic malignancy from which the patient is currently in complete remission
• Contraindication to the use of iodinated contrast-enhanced CT agents, based on:
• Severe allergy (for which pre-medication cannot limit adverse reactions) or
• Estimated glomerular filtration rate (GFR) ≤ 30 ml/min/1.73m\^2
• Prior use of systemic therapy treatment for kidney cancer (PD-1, PD-L1, tyrosine kinase or TOR inhibitor) or radiotherapy within 4 weeks of enrollment
• Exposure to experimental diagnostic or therapeutic drug within 14 days from date of planned administration

Sponsors & Collaborators

• Jonsson Comprehensive Cancer Center: lead
• Telix Pharmaceuticals (Innovations) Pty Limited: collaborator

Study Sites (1)

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, 90095, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

Specimen Handling; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Spectrum Analysis; Chemistry Techniques, Analytical

Study Officials

• Brian Shuch

  UCLA / Jonsson Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: June 6, 2024
• Study Start: August 6, 2024
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): December 1, 2030
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

US (1)