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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

RecruitingPhase 2Ages 18 Years - anyAllJonsson Comprehensive Cancer Center
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In plain words

What the trial is, and whether it could suit you

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 cell

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age โ‰ฅ 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) โ‰ค 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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What it tests

  • Biospecimen Collection
  • Bone Scan
  • Computed Tomography
  • Magnetic Resonance Imaging
  • Positron Emission Tomography
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Where

1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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