68Ga-NY104 PET/CT in Patients With Metastasis/Recurrence Clear Cell Renal Cell Carcinoma Suspicion
Clear Cell Renal Cell Carcinoma
About this trial
This is an interventional diagnostic trial for Clear Cell Renal Cell Carcinoma focused on measuring 68Ga-NY104, PET/CT, Clear Cell Renal Cell Carcinoma
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 y Histopathological diagnosis of clear cell renal cell carcinoma Suspected of metastasis or recurrence from ccRCC based on previous conventional imaging or 18F-FDG PET/CT scan. Expected survival of at least 6 months ECOG ≤ 2 Written informed consent provided for participation in the trial In the opinion of investigator, willing and able to comply with required study procedures. Exclusion Criteria: On VEGF TKI treatment less than 1 week before 68Ga-NY104 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NY104. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NY104 PET/CT is required. Patients on HIF antagonist treatment < 3 months before 68Ga-NY104 PET/CT. CA9, which encodes carbonic anhydrase IX (CAIX), is one of the genes most strongly upregulated by HIF-1. HIF antagonist, such as Belzutifan, might affect the expression of CAIX and thus the binding of 68Ga-NY104 to tumor. Withdraw of at least 3 months is required for HIF antagonist. Pregnancy or breastfeeding. Severe claustrophobia.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Experimental
68Ga-NY104 PET/CT
Each patient will receive one dose of 68Ga-NY104 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.