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

Inclusion Criteria: 1. Capable of understanding and voluntarily signing the informed consent form; able to complete the trial in accordance with the protocol requirements; 2. Age 18-75 years; no gender restrictions; 3. 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; 4. At least 1 measurable solid lesion in the subject, which can be accurately and continuously measured using modified RECIST criteria (version 1.1); 5. ECOG performance status score of 0-2; 6. Laboratory parameters must meet: 1. 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); 2. 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; 3. Other routine tests: Within normal ranges or deemed acceptable by the investigator; 7. Expected survival ≥12 weeks; 8. 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. Exclusion Criteria: 1. Recovery from major trauma (including surgery) within 4 weeks prior to study examination; 2. Patients with systemic or local severe infections or other serious comorbidities; 3. Severe hepatic or renal dysfunction; 4. Refusal to participate in this clinical study; 5. Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution; 6. Childbearing-aged male or female subjects who cannot adopt effective contraception; 7. Women planning pregnancy, currently pregnant, or lactating; 8. Patients unable or unwilling to undergo PET/CT scanning; 9. Other subjects deemed ineligible by the investigator.