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Investigating 89Zr-DFO-GmAb PET/CT for Recurrent Kidney Cancer

This study is comparing a new imaging scan, 89Zr-DFO-GmAb PET/CT, to standard contrast-enhanced CT scans. The goal is to see which method is better at finding clear cell renal cell cancer (a type of kidney cancer) that has returned after surgery. For some patients, there's a high chance the cancer might come back, and current scans might miss small cancer cells. The 89Zr-DFO-GmAb PET/CT uses a special antibody (Girentuximab, or GmAb) tagged with a radioactive substance (zirconium-89) to help detect these cancer cells. We are looking for 91 participants aged 18 or older who have clear cell renal cell carcinoma confirmed by biopsy or surgery. The main goal is to see how well each scan finds cancer lesions up to 16 weeks after surgery.

Study design
This is an interventional study with a planned enrollment of 91 participants. It compares two different imaging methods for detecting recurrent kidney cancer.
What's involved
You would undergo blood sample collection, bone scans, CT scans (including PET/CT and brain CT), and potentially an MRI of the brain.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for lesion detection is measured up to 16 weeks from surgical resection.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06447103

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Jonsson Comprehensive Cancer Center
~91 participants
Updated 2026-06-15 on ClinicalTrials.gov
What's tested:Biospecimen CollectionBone ScanComputed TomographyMagnetic Resonance ImagingPositron Emission TomographyQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Lesion detection rate
Measured over Up to 16 weeks from surgical resection

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

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • UCLA / Jonsson Comprehensive Cancer Center

    Los Angeles, Californiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Brian Shuch · PRINCIPAL_INVESTIGATOR · UCLA / Jonsson Comprehensive Cancer Center

Who to contact

Brian Shuch
[email protected]
310-794-0987
Email the study team

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Eligibility criteria

Inclusion

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
Individual must be able to remain still and lie flat for duration of the diagnostic imaging procedure (less than 1 hour)

Exclusion

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
Women who are pregnant or breastfeeding
Known hypersensitivity to girentuximab
Known inability to remain still and lie flat imaging procedure (about 30 minutes)

What this trial measures

  • Lesion detection rateUp to 16 weeks from surgical resection

    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.