Evaluation of Safety, Pharmacokinetics, Distribution，Radiation Safety and Sensitivity/Specificity of PET/CT Imaging With 68Ga-NYM096 in Participants With IRM

This will be a prospective, open-label, single-center phase I study. Histological confirmation will serve as standard of truth, to assess sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), as well as accuracy of 68Ga-NYM096 PET/CT Imaging.

A total of 20~40 participants with IRM scheduled for surgical resection will be enrolled and assigned to two dose groups. Each participant will receive a single injection of the assigned dose; dose escalation within the same participant is not permitted. The study includes screening period, dosing/imaging period, safety follow-up visit, and surgery follow-up period.

Inclusion criteria

• Imaging evidence of a single indeterminate renal mass on contrast-enhanced CT or MRI, with planned partial or radical nephrectomy to be performed within 90 days following administration of 68Ga-NYM096.
• Age ≥18 years at the time of signing the informed consent form;
• ECOG score 0-2;
• Life expectancy ≥6 months;
• Negative pregnancy test for women of childbearing potential, and participants (including male participants) agree to use effective contraception during the study and for at least 3 months after dosing;
• Willing and able to comply with scheduled visits, diagnostic plans, clinical laboratory tests, and other trial procedures

Exclusion criteria

• A biopsy procedure only (rather than partial or radical nephrectomy) planned for histological species delineation of IRM;
• Participants diagnosed with other malignancies that may affect life expectancy or interfere with disease assessment, except for those with a history of malignancy that has been adequately treated and in remission for over 3 years, and those with adequately treated non-melanoma skin cancer.
• Known or suspected allergy to the investigational drug or to acetazolamide, sulfonamides.
• Any radionuclide used within 10 half-lives before 68Ga-NYM096 PET/CT.
• Received other investigational drugs before 68Ga-NYM096 PET/CT, within 5 half-lives of that drug or within 28 days after its last dose, whichever is longer.
• Severe non-malignant diseases (e.g., psychiatric, infectious, autoimmune, or metabolic diseases) that may interfere with study objectives or, in the investigator's judgment, affect participant safety or compliance.
• Participants with active chronic hepatitis B (e.g., hepatitis B surface antigen [HBsAg] positive with HBV DNA ≥ lower limit of detection), active hepatitis C (e.g., hepatitis C virus [HCV] antibody positive with HCV RNA ≥ lower limit of detection), human immunodeficiency virus (HIV) infection, or active syphilis infection (positive for both treponemal-specific and non-treponemal antibodies).
• Inability to lie quietly and flat in the scanner during PET examination, or conditions such as claustrophobia preventing cooperation with PET examination.
• Other situations where the investigator considers the participant unsuitable for this study