RecruitingNot ApplicableNCT06769893

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

Sponsor

Xijing Hospital

Enrollment

60 participants

Start Date

Jun 12, 2024

Study Type

INTERVENTIONAL

Conditions

RCC, Renal Cell Cancer

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

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new PET scan agent called 68Ga-NOTA-RCCB6 that targets a protein called CD70, found on kidney cancer cells. Researchers want to see if this scan helps detect, stage, and monitor renal cell carcinoma (kidney cancer) more accurately than existing scans. **You may be eligible if...** - You are between 18 and 75 years old - You have suspected or confirmed kidney cancer based on conventional imaging - You are willing and able to follow the study procedures **You may NOT be eligible if...** - You have already received anti-tumor treatment before the scan - You have serious neurological, heart, liver, kidney, or immune system diseases - You have claustrophobia or cannot tolerate intravenous injections - You have been diagnosed with another cancer in the past year - You are pregnant or breastfeeding - You participated in another interventional clinical trial within the past month Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TEST68Ga-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

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NCT06769893

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