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

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 91

Inclusion Criteria

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)

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lesion detection rate

Secondary Outcome Measures

Name	Time	Method
Incidence of adverse events (AEs);Positive predictive value (PPV);Recurrence-free survival;Change in management and perceived clinical utility of the unblinded read/report of positron emission tomography/ computed tomography (PET/CT)

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