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

NCT07301827 | Recruiting

• 1 other identifier: XLan-0923
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma

Keywords

Renal cell carcinoma; PET imaging; PSMA; CAIX; CD70

Outcome Measures

Primary Outcomes (1)

• Visual and standardized uptake values assessment of lesions and biodistribution

  At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.

  1 year

Secondary Outcomes (2)

• Radioactivity in the blood and urine samples

  Blood samples were collected at 25 minutes, 55 minutes and 115 minutes after injection.

• Pathological sections of tumor tissue

  up to 1 year

Study Arms (3)

PET imaging targeting CAIX in renal cell carcinoma

EXPERIMENTAL

Drug: [68Ga]Ga-DOTA-CAIX peptide

PET imaging targeting PSMA in renal cell carcinoma

EXPERIMENTAL

Drug: [68Ga]Ga-PSMA

PET imaging targeting CD70 in renal cell carcinoma

EXPERIMENTAL

Drug: [68Ga]Ga-NOTA-CD70 antibody fragment

Interventions

[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.

PET imaging targeting CD70 in renal cell carcinoma

[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.

PET imaging targeting PSMA in renal cell carcinoma

[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.

PET imaging targeting CAIX in renal cell carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tumor subjects:
• The subject or his/her legal representative is able to sign the informed consent form signed and dated;
• Promise to abide by the research procedures and cooperate with the implementation of the whole process of research;
• Adult subjects (aged 18 years or above), male or female;
• 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;
• Conform to specific laboratory test results;
• 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;
• Other set selection criteria.
• Healthy Subjects:
• Fully understand and voluntarily sign the informed consent form;
• Male or female, age 18-70 years old;
• 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);
• 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;
• There is no abnormality in vital signs examination and physical examination;
• 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;

You may not qualify if:

• Tumor subjects:
• Those who are unable to complete PET/MR or PET/CT examination (including inability to lie flat, claustrophobia, radiophobia, etc.);
• 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;
• Patients who are pregnant or lactating;
• Those who have other factors that are not suitable for participating in this test.
• Healthy Subjects:
• Any serious or unstable medical condition; Those who have acute illness before the study; Previous or existing malignancy;
• Pregnant and lactating women;
• 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 used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines) within 2 weeks before the trial;
• Participation in other research studies involving radioactive materials (within the past 12 months);
• Any other factors that affect the results of the study.

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430022, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Renal Cell

Interventions

gallium 68 PSMA-11

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Xiaoli Lan

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2025
• First Posted: December 24, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)