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Recruiting NCT07301827

Study on the Diagnostic Value of Novel PET Molecular Imaging for Renal Cell Carcinoma

Trial Parameters

Condition Renal Cell Carcinoma
Sponsor Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study Type INTERVENTIONAL
Phase N/A
Enrollment 66
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-06-01
Completion 2026-05-31
Interventions
[68Ga]Ga-DOTA-CAIX peptide[68Ga]Ga-NOTA-CD70 antibody fragment[68Ga]Ga-PSMA

Brief Summary

This study is a diagnostic study. This project aims to explore the clinical application value of PET imaging technologies targeting PSMA, CAIX, and CD70 in renal cell carcinoma. By utilizing PSMA-targeted PET radiopharmaceuticals (e.g., \[⁶⁸Ga\]Ga-PSMA), CAIX-targeted PET radiopharmaceuticals (e.g., \[⁶⁸Ga\]Ga-DOTA-CAIX), and CD70-targeted PET radiopharmaceuticals (e.g., \[⁶⁸Ga\]Ga-NOTA-CD70 antibody fragment) in patients with clinically suspected or confirmed renal cell carcinoma and healthy volunteers, we will investigate their diagnostic and therapeutic potential. \[⁶⁸Ga\]Ga-DOTA-CAIX peptide as an example), and a PET imaging agent targeting CD70 (\[⁶⁸Ga\]Ga-NOTA-CD70 antibody fragment as an example) in patients with clinically suspected or confirmed renal cell carcinoma and healthy volunteers. Integrated PET/MR or PET/CT imaging will be performed to aid in the diagnosis and staging of renal cell carcinoma, assess tumor burden and the expression levels of PSMA, CAIX, and CD70, and assist in determining treatment strategies. Concurrently, preliminary pharmacokinetic analysis of the novel CAIX-targeting molecular probe will be conducted in healthy volunteers to elucidate its metabolic patterns and adverse reactions in vivo.

Eligibility Criteria

Inclusion Criteria: Tumor subjects: 1. The subject or his/her legal representative is able to sign the informed consent form signed and dated; 2. Promise to abide by the research procedures and cooperate with the implementation of the whole process of research; 3. Adult subjects (aged 18 years or above), male or female; 4. Patients with clinically suspected or confirmed renal cell carcinoma (supporting evidence includes serum-related tumor markers, ultrasound, CT, MRI and other imaging data and histopathological examinations, etc.), and are in good general condition; 5. Conform to specific laboratory test results; 6. Contraception for at least one month before screening for females in the childbearing period, and commitment to use contraception throughout the study period and continue until the specified time after the end of the study; 7. Other set selection criteria. Healthy Subjects: 1. Fully understand and voluntarily sign the informed consent form; 2. Male or female, age 18-70 yea

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