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

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.

Eligibility

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.

Conditions2

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