A Study of the Clinical Application of [18F]RCCB6 PET/CT Imaging in the Diagnosis of Kidney Cancer

What this Trial Is About

Researchers are studying a new imaging method using [18F]RCCB6 PET/CT to detect kidney cancer, especially clear cell renal cell carcinoma and papillary renal cell carcinoma. This Phase 2 study aims to optimize this imaging technique and assess how well it diagnoses kidney cancer compared to standard imaging methods like CT, MRI, and [18F]FDG PET/CT. The study also looks at how tumor uptake of the imaging agent relates to protein expression in the cancer tissue and explores its potential role in treatment decisions such as staging and surveillance. Participants will receive an injection of [18F]RCCB6 at a dose of 0.05-0.1 mCi/kg. One hour after the injection, they will undergo a whole-body immunoPET/CT scan targeting CD70, a protein found in kidney cancer cells. The imaging will be evaluated both visually and quantitatively by measuring uptake values in tumors and normal tissues. The diagnostic performance, including sensitivity and specificity, will be compared with other imaging methods. An interim assessment will be done once over half of the patients are enrolled. During the study, participants will have their biodistribution and uptake of [18F]RCCB6 measured within one day after injection. Researchers will also assess the correlation between CD70 protein expression and imaging uptake, and the diagnostic value of this imaging within 30 to 180 days. The impact of this imaging on clinical decision-making will be examined over 3 to 6 months. Safety will be monitored, and participants will be followed up according to the study schedule until its completion in November 2027.

CD70-targeted immunoPET Imaging of Kidney Cancer