A Study Evaluating the Value of 68Ga-NOTA-RCCB6 PET Imaging for Targeting CD70 in the Clinical Staging, Therapeutic Evaluation, and Restaging of Renal Cell Carcinoma, and Comparing It with 68Ga-PSMA PET/CT Imaging
68Ga-NOTA-RCCB6 PET/CT Scan: The imaging agent 68Ga-NOTA-RCCB6 used in this project is synthesized following the standards for radiopharmaceutical production, with reference to the Chinese Pharmacopoeia (quality standards for 18F-FDG). The pH value is between 5.0 and 8.0; the radiochemical purity is not less than 95%, and the bacterial endotoxin content in each milliliter of solution is less than 15EU; the radioactive concentration is not less than 37 MBq/mL; the solvent residues comply with the regulations.
Specification: 185\~1850 MBq/ml Characteristics: Clear, colorless, no visible particles. Radioactive physical half-life: 68Ga is 68 minutes. Expiry: Calculated from the time of labeling, stable for 3 half-lives. Administration method: Intravenous injection. Dosage: 0.05-0.1mCi/kg, flush with 5 mL of saline after injection. The maximum mass dose of CD70 should not exceed 240ug, and the maximum volume of administration should not exceed 5 mL.
Study summary
This is a prospective, open-label, single-center clinical study targeting renal cell carcinoma. Sixty patients with a high clinical suspicion of renal cell carcinoma were included. Qualified subjects will undergo 68Ga-NOTA-RCCB6 PET/CT examination. The aim is to establish the optimal imaging protocol; evaluate the distribution characteristics and correlations of physiological and pathological positive uptake, and using pathological results as the gold standard, assess the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma.
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
\- The subject or legal guardian/caregiver must voluntarily sign the informed consent form.
Ages 18 to 75 years old. Patients with suspected renal cell carcinoma based on conventional imaging studies, and who undergo 68Ga-PSMA PET/CT scanning.
Patients with suspicious lymph nodes or distant metastases detected by conventional imaging or 68Ga-PSMA PET/CT.
Willing and able to follow the study protocol.
Exclusion Criteria:
\- Patients who have received anti-tumor treatment prior to PET/CT scan. Suffer from severe other neurological diseases, or gastrointestinal, cardiovascular, liver, kidney, blood system, respiratory system, immunodeficiency and other serious diseases.
Alternative subjects have contraindications to PET/CT scanning. Including but not limited to: those who cannot tolerate repeated intravenous injections; those who may be allergic to the drug and its components (including those with a history of severe allergies or allergic reactions, especially those with allergies to the tested drug); claustrophobia.
In the past year, diagnosed with other malignant tumors; alternative subjects have undergone major surgery in the past 3 months; received experimental drug or device treatment with unclear effects or safety within the past month, or have participated in other interventional clinical trials.
Pregnant or lactating women. Patients who are lost to follow-up. Other conditions that, in the researcher's assessment, may affect the study or make the subject unsuitable for participation in the study.
Primary outcome measure(s)
Maximum Standardized uptake value (SUVmax) — 1 day from injection of the tracer Maximum Standardized uptake value (SUVmax) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' primary and/or metastatic lesions.
Mean Standardized Uptake Value(SUVmean) of liver — 1 day from injection of the tracer Mean Standardized uptake value (SUVmean) of \[68Ga\]RCCB6 and \[68Ga\]PSMA in the included subjects' liver.
Tumor to Background Ratio(TBR) — 1 day from injection of the tracer TBR=SUVmax/SUVmean
The correlation between CD70 expression and [18F]RCCB6 uptake value — 30 days from injection of the tracer The Standardized uptake value (SUV) of \[68Ga\]RCCB6 will be calculated, and the correlation between pathological results and tumor uptake of \[68Ga\]RCCB6 will be analyzed.
Trial sites (1)
Facility
City
Region
Status
Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China
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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