Multicenter Study of 18F-Labeled NY104 for PET/CT Imaging in Renal Cell Carcinoma

Prior treatment

• Recovery from major trauma (including surgery) within 4 weeks prior to study examination;

Other illness

• Patients with systemic or local severe infections or other serious comorbidities;
• Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;

Age

• Childbearing-aged male or female subjects who cannot adopt effective contraception;

Other

• Severe hepatic or renal dysfunction;
• Refusal to participate in this clinical study;
• Women planning pregnancy, currently pregnant, or lactating;
• Patients unable or unwilling to undergo PET/CT scanning;
• Other subjects deemed ineligible by the investigator.

• Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements;
• Age 18-75 years; no gender restrictions;
• Clinically diagnosed/suspected renal cell carcinoma, clinically diagnosed/suspected recurrence and/or metastasis after treatment of renal cell carcinoma, or CAIX-positive solid tumors, including but not limited to breast cancer and nasopharyngeal carcinoma;
• At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1);
• ECOG performance status score of 0-2;
• Laboratory parameters must meet:
  • Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90 g/L; PT or APTT ≤1.5×ULN (upper limit of normal);
  • Liver and kidney function: T-Bil ≤1.5×ULN, ALT/AST ≤2.5×ULN or ≤5×ULN (for subjects with liver metastasis), ALP ≤2.5×ULN (if bone or liver metastasis is present, ALP ≤4.5×ULN); BUN ≤1.5×ULN, SCr ≤1.5×ULN;
  • Other routine tests: Within normal ranges or deemed acceptable by the investigator;
• Expected survival ≥12 weeks;
• Female subjects: Effective contraception (defined as sterilization, intrauterine hormone device, condoms, contraceptives/agents, abstinence, or partner vasectomy) must be used during the study and for 6 months post-study; Male subjects: Agreement to use contraception during the study and for 6 months post-study.