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

Sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study ID
NCT07301827
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • [68Ga]Ga-DOTA-CAIX peptide — DRUG
    To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed renal cell carcinoma with high CAIX expression and healthy volunteers, using specific positron imaging agents targeting CAIX (taking \[68Ga\]Ga-DOTA-CAIX peptide as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan. Healthy volunteers: Pharmacokinetic analysis will be performed to clarify the distribution and metabolism of the drug in the body and its safety.
  • [68Ga]Ga-NOTA-CD70 antibody fragment — DRUG
    To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed renal cell carcinoma with high CD70 expression and healthy volunteers, using specific positron imaging agents targeting CD70 (taking \[68Ga\]Ga-NOTA-CD70 antibody fragment as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan.
  • [68Ga]Ga-PSMA — DRUG
    To perform integrated PET/MR or PET/CT visualization of patients with clinically suspected or confirmed renal cell carcinoma with high PSMA expression and healthy volunteers, using specific positron imaging agents targeting PSMA (taking \[68Ga\]Ga-PSMA as an example), to achieve the following purposes: Patients with malignant tumors: for diagnosis and staging of diseases, comparing with the gold standard pathological diagnosis, evaluating diagnostic efficacy, clarifying the presence or absence of lesions, and determining the location and nature of lesions; comparing with \[18F\]FDG PET for accurate staging, evaluating the tumor load, and helping to determine the therapeutic plan.

Study Details

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.

Key Dates

First listed
Dec 24, 2025
Start date
Jun 1, 2025
Status verified
Dec 2025
Primary completion
May 31, 2026
Completion
May 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: PET imaging targeting CAIX in renal cell carcinoma
  • Experimental: PET imaging targeting PSMA in renal cell carcinoma
  • Experimental: PET imaging targeting CD70 in renal cell carcinoma

Primary Outcome Measure

Visual and standardized uptake values assessment of lesions and biodistribution [ Time Frame: 1 year ]

Central Contacts

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