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

Summary

This study aims to evaluate the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in detecting primary, recurrent, and metastatic lesions of renal cell carcinoma (RCC), and to explore its potential for imaging and treatment response assessment in other CAIX-positive solid tumors, such as breast cancer and nasopharyngeal carcinoma, where high CAIX expression is associated with poor prognosis. The study will also investigate the effect of oral low-dose acetazolamide on the biodistribution of 18F-NY104, particularly in the stomach and kidneys.

Eligibility

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.

Conditions3

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