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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Xiaoli Lan
• Email: lxl730724@hotmail.com
• Phone: 0086-027-83692633

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.