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RECRUITING
NCT06769893
NA

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

Sponsor: Xijing Hospital

View on ClinicalTrials.gov

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.

Official title: A Prospective, Open-label, Single-center Study of CD70-Specific PET/CT Imaging for Non-invasive Diagnosis of Renal Cell Carcinoma

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-06-12

Completion Date

2025-11-07

Last Updated

2025-01-10

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

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.

Locations (1)

Department ofNuclear Medicine,Xijing Hospital, Fourth Military Medical University, Xi'an, China

Xi'an, China, Shaanxi, China