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Compares treatment options for Clear Cell Renal Cell Carcinoma
Official title 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
ClinicalTrials.gov ID: NCT06447103
What this study is testing
What is Zirconium Zr 89 Girentuximab?
Zirconium Zr 89 Girentuximab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for clear cell renal cell carcinoma.
Also referred to as 89Zr-DFO-TFP-girentuximab, 89Zr-girentuximab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- people must have undergone definitive treatment of their primary tumor (partial/radical nephrectomy) +/- resection of metastatic disease to no...
- Surgery must have been performed between 4-16 weeks at the time of planned imaging
You likely can't join if
- 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
See the full eligibility 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
- people 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
- people 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)
- 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)
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.