TheranosticTrials.org

Clinical Trial · NCT07301827

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

Overview

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.

Sponsor

Norwegian University of Science and Technology

Phase

N/A

Contacts

Xiaoli Lan (CONTACT)

lxl730724@hotmail.com

0086-027-83692633

ClinicalTrials.gov

NCT07301827

Drug / Compound

PSMA

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

CD70 antibody fragment

Isotope(s):
Target(s):
  • CD70
Ligand Class: Small Proteins and Antibody Fragments
Chelator: NOTA

CAIX peptide

Isotope(s):
Target(s):
  • CAIX
Ligand Class: Peptides
Chelator: DOTA

Eligibility

Inclusion

  • Promise to abide by the research procedures and cooperate with the implementation of the whole process of research;
  • Other set selection criteria.Healthy Subjects:
  • No history of chronic or serious diseases such as cardiovascular, liver, kidney, respiratory, blood and lymphatic, endocrine, immunologic, psychiatric, neuromuscular, gastrointestinal system, etc., within three years, and in good general health;
  • Tumor subjects:
  • Conform to specific laboratory test results;
  • There is no abnormality in vital signs examination and physical examination;
  • Able to communicate well with the investigator, and understand and comply with the requirements of the study.
  • Have no fertility plan during the trial and within 6 months after the end of the trial and voluntarily take effective contraceptive measures and have no sperm and egg donation plans;
  • 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;
  • Male weight \>=50.0kg, female weight \>=45.0kg; Body mass index (BMI) within the range of 19.0\~26.0kg/m\^2 (including the cut-off value);
  • 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;

Exclusion

  • Patients with known hypersensitivity to targeted PSMA, CAIX or CD70 PET imaging agents or synthetic excipients; The fasting blood glucose level before injection of \[18F\]FDG exceeded 11.0 mmol/L;
  • Tumor subjects:
  • Patients who are pregnant or lactating;
  • Those who have used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines) within 2 weeks before the trial;
  • Pregnant and lactating women;
  • Those who are unable to complete PET/MR or PET/CT examination (including inability to lie flat, claustrophobia, radiophobia, etc.);
  • Any serious or unstable medical condition; Those who have acute illness before the study; Previous or existing malignancy;
  • Any other factors that affect the results of the study.
  • Those who have undergone surgery within 6 months before the trial, which is judged by the investigator to affect absorption, distribution, metabolism, and excretion;
  • Those who have other factors that are not suitable for participating in this test.Healthy Subjects:
  • Participation in other research studies involving radioactive materials (within the past 12 months);