Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
NCT07301827

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

Led by Union Hospital, Tongji Medical College, Huazhong University of Science and Technology · Updated on 2025-12-24

66

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to sign informed consent and cooperate with study procedures
  • Adults aged 18 years or older, male or female
  • Patients with suspected or confirmed renal cell carcinoma and in good health
  • Meet specific laboratory test requirements
  • Females of childbearing potential must use contraception before and during the study
  • Healthy volunteers aged 18 to 70 years, with weight and BMI within specified ranges
  • Healthy volunteers must have no history of serious chronic diseases within 3 years
  • Healthy volunteers must have normal vital signs and no fertility plans during and 6 months after the study
  • Able to communicate well and comply with study requirements
Not Eligible

You will not qualify if you...

  • Unable to complete PET/MR or PET/CT imaging (due to inability to lie flat, claustrophobia, radiophobia, etc.)
  • Known allergy to PSMA, CAIX, or CD70 imaging agents or their components
  • Fasting blood glucose over 11.0 mmol/L before FDG injection
  • Pregnant or lactating women
  • Other factors making participation unsuitable
  • Healthy volunteers with serious or unstable medical conditions or acute illness
  • Previous or current cancer in healthy volunteers
  • Surgery within 6 months before study affecting drug metabolism
  • Use of any drugs within 2 weeks before study
  • Participation in other studies with radioactive materials within past 12 months
  • Any other factors that could affect study results

AI-Screening

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Trial Site Locations

Total: 1 location

1

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China, 430022

Actively Recruiting

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Research Team

X

Xiaoli Lan

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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