[18F]RCCB6: Enrolled patients will receive 0.05-0.1mCi/kg of \[18F\]RCCB6. ImmunoPET/CT imaging will be acquired 1 hour after \[18F\]RCCB6 injection.
Study summary
The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.
Eligibility
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Aged 18-80 year-old and of either sex；
2. Histologically confirmed diagnosis of kidney cancer (especially clear cell renal cell carcinoma and papillary renal cell carcinoma) or suspected kidney cancer by diagnostic imaging;
3. Capable of giving signed informed consent, including compliance with the requirements and restrictions listed in the informed consent form (ICF) and this protocol.
Exclusion Criteria:
1. Pregnancy；
2. Severe hepatic and renal insufficiency;
3. History of serious surgery in the last month;
4. Allergic to antibody or single-domain antibody radiopharmaceuticals.
Primary outcome measure(s)
Biodistribution of [18F]RCCB6 — 1 day from injection of the tracer Measurement of the overall biodistribution of \[18F\]RCCB6 in normal tissues and organs.
Standardized uptake value (SUV) — 1 day from injection of the tracer Standardized uptake value (SUV) of \[18F\]RCCB6 in the included subjects' primary and/or metastatic lesions.
The correlation between CD70 expression and [18F]RCCB6 uptake value — 60 days The Standardized uptake value (SUV) of \[18F\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[18F\]RCCB6 will be analyzed.
Diagnostic value of [18F]RCCB6 PET in patients with ccRCC — 30 days We will calculate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy of \[18F\]RCCB6 PET/CT in patients with ccRCC. We will also compare the diagnostic value of \[18F\]RCCB6 with that of traditional imaging tracers (e.g., 18F-FDG) and imaging modalities (e.g., CT and MRI). All the above goals will be achieved by analyzing the static/dynamic \[18F\]RCCB6 PET/CT imaging data. Systematic evaluation of these parameters will elucidate the pharmacokinetics, pharmacodynamics, and, more importantly, the clinical value of \[18F\]RCCB6 PET/CT for patients with ccRCC.
To explore the diagnostic performance of [18F]RCCB6 PET with that of conventional imaging and [18F]FDG PET — 6 months Using pathological or follow-up imaging data as the gold standard, explore the diagnostic performance of \[18F\]RCCB6 PET compared to conventional imaging and \[18F\]FDG PET.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital, School of Medicine, Shanghai Jiao Tong University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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