PET imaging that targets PSMA, CAIX, and CD70 to detect and stage renal cell carcinoma.

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

This project will test whether PET scans that target PSMA, CAIX, and CD70 can accurately detect and map renal cell carcinoma in adults with suspected or confirmed disease and in healthy volunteers.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 66 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology (Academic / other)
• Drugs / interventions: immunotherapy
• Locations: 1 site (Wuhan, Hubei)
• Trial ID: NCT07301827 on ClinicalTrials.gov

What this trial studies

This diagnostic imaging protocol uses three PET radiotracers—[68Ga]Ga-PSMA, [68Ga]Ga-DOTA-CAIX, and [68Ga]Ga-NOTA-CD70 antibody fragment—to image adults with suspected or confirmed renal cell carcinoma and healthy volunteers. Participants undergo integrated PET/MR or PET/CT to measure tracer uptake, estimate tumor burden, and assess expression of PSMA, CAIX, and CD70 in lesions. Imaging findings will be compared with clinical, pathological, and standard imaging data to determine diagnostic performance and potential staging advantages. The goal is to identify which tracer or combination provides the most reliable whole-body assessment for RCC.

Who should consider this trial

Good fit: Adults (≥18 years) with clinically suspected or confirmed renal cell carcinoma who meet laboratory and safety criteria are eligible, and healthy volunteers aged 18–70 may participate as controls.

Not a fit: Patients whose tumors lack PSMA, CAIX, or CD70 expression, pregnant individuals, or those with contraindications to PET/CT or PET/MR are unlikely to benefit from the imaging evaluated here.

Why it matters

Potential benefit: If successful, these targeted PET agents could enable earlier and more accurate detection and staging of RCC and help guide personalized treatment decisions.

How similar studies have performed: PSMA-targeted PET has shown promising but variable results in RCC in prior reports, while CAIX- and CD70-targeted PET imaging remain earlier-stage and largely exploratory.

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 years old;
3. 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);
4. 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;
5. There is no abnormality in vital signs examination and physical examination;
6. 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;
7. Able to communicate well with the investigator, and understand and comply with the requirements of the study.

Exclusion Criteria:

Tumor subjects:

1. Those who are unable to complete PET/MR or PET/CT examination (including inability to lie flat, claustrophobia, radiophobia, etc.);
2. 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;
3. Patients who are pregnant or lactating;
4. Those who have other factors that are not suitable for participating in this test.

Healthy Subjects:

1. Any serious or unstable medical condition; Those who have acute illness before the study; Previous or existing malignancy;
2. Pregnant and lactating women;
3. Those who have undergone surgery within 6 months before the trial, which is judged by the investigator to affect absorption, distribution, metabolism, and excretion;
4. Those who have used any drugs (including prescription drugs, over-the-counter drugs, and Chinese herbal medicines) within 2 weeks before the trial;
5. Participation in other research studies involving radioactive materials (within the past 12 months);
6. Any other factors that affect the results of the study.

Where this trial is running

Wuhan, Hubei

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)

Study contacts

• Study coordinator: Xiaoli Lan

Conditions Renal Cell Carcinoma; Renal cell carcinoma; PET imaging; PSMA; CAIX; CD70