Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:23 PM
Ignite Modification Date:
2025-12-24 @ 7:23 PM
NCT ID:
NCT06447103
Eligibility 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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06447103
Study Brief:
Protocol Section:
NCT06447103