NCT06769893

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Xijing Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This research process is divided into screening period, baseline period, safety visit period, and diagnostic efficacy follow-up period. 1. Screening period (D-7 to D-1): No more than 7 days Screening is conducted within 7 days before the administration of 68Ga-NOTA-RCCB6 (D-7 to D-1). Before any study-related procedures, subjects must sign a written informed consent form. After signing the informed consent form, the following screening procedures are performed: ① Review of inclusion/exclusion criteria. * Collection of medical history, including but not limited to clinical data of the subjects and relevant auxiliary examination results (routine imaging examinations, tumor markers, biopsy results, etc.), numbering each subject and establishing a medical record. * Collection of demographic data (including gender, age, etc.). ④ Recording of concomitant medications/adverse events. If any inclusion criteria are not met or any exclusion criteria are met, the screening is considered failed. 2. Baseline period (drug/administration period) (D0): 1 day Subjects who meet all inclusion criteria and do not meet any exclusion criteria will receive an injection of 68Ga-NOTA-RCCB6 and undergo a PET/CT scan on D0. The following assessments are performed again before administration, and only after a comprehensive evaluation by the doctor are they eligible for injection. * Concomitant medications after screening visit ② Weight * Vital signs * Adverse events Single dose, 0.05-0.1mCi/kg body weight, intravenous injection of 68Ga-NOTA-RCCB6 0.05-0.1mCi/kg PET/CT scan is performed 50-80 minutes after administration. 3. Safety visit period (D0 to D4): 4 days * Follow-up on whether subjects have adverse reactions after administration. ② 2 hours ± 10 minutes after administration: monitoring of adverse events in subjects. ③ 1-4 days after administration: telephone follow-up to assess for delayed adverse events. 4. Diagnostic efficacy follow-up period (D1 to D180): 6 months Follow-up on biopsy/surgical pathology results of subjects (preferably completed within 1 month after imaging) and imaging results to confirm the diagnostic efficacy of 68Ga-NOTA-RCCB6 PET/CT in renal cell carcinoma. When conducting diagnostic efficacy follow-up, the following should be recorded simultaneously: concomitant medications and adverse events. 5. Withdrawal from study/premature termination of study If patients do not complete the PET examination according to the process, for subjects who withdraw prematurely, the following follow-up should be completed: ① Concomitant medications ② Adverse events 6. Premature termination or suspension of study Reasons for study termination may include but are not limited to: new information on safety, requirements of the competent authorities. Other reasons include but are not limited to: excessive protocol violations, insufficient concern for subject safety, researcher turnover or insufficient staffing, etc. In the event of any of the following situations during the study, the study may be terminated, and the competent authority should promptly report to the health department responsible for clinical research registration: * There is a violation of laws and regulations, rules; * There is a violation of ethical principles or the principles of scientific integrity; * During the study, it is found that the study drug may have serious quality defects; ④ Serious safety risks are found in clinical research; * There is commercial bribery or other improper interest relationships; ⑥ Other situations that should stop the study. For all situations where the study is suspended or terminated, appropriate steps will be taken to ensure the safety of the subjects. Definition of study completion: PET imaging, result analysis, and necessary clinical follow-up of all study subjects have been completed.

Conditions

• RCC, Renal Cell Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-06-12
• Primary completion: 2025-04-01
• Completion: 2025-11-07
• First posted: 2025-01-10
• Last updated: 2025-01-10

Locations

1 site across 1 country: China