Radioactive antibody hunt: could a new scan outsmart hidden kidney cancer?
NCT ID NCT06447103
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This Phase II trial tests whether a special PET/CT scan using a radioactive tracer called 89Zr-DFO-girentuximab can find recurrent clear cell renal cell carcinoma after surgery better than standard contrast-enhanced CT. The tracer attaches to a protein (CAIX) on kidney cancer cells, making them visible on the scan. About 91 adults who had surgery for kidney cancer will be enrolled to compare the two imaging methods.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 89Zr-DFO-girentuximab (a radioactive tracer that attaches to CAIX protein on kidney cancer cells)
- What this could lead to
- If successful, this imaging method could detect recurrent kidney cancer earlier and more accurately than standard CT scans, potentially improving treatment decisions.
- What could go wrong
- This is a Phase II trial with only 91 participants, so results may not apply to all patients. The new tracer involves radiation exposure and may not detect all recurrences.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 91 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2024
- Expected to finish
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Dec 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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UCLA / Jonsson Comprehensive Cancer Center
RECRUITINGLos Angeles, California, 90095, United States
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