RecruitingNCT06916624

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

Sponsor

The Affiliated Hospital of Qingdao University

Enrollment

40 participants

Start Date

Apr 12, 2025

Study Type

OBSERVATIONAL

Conditions

Renal Cell Carcinoma (RCC)Clear-Cell Renal-Cell Carcinoma (ccRCC)

Summary

Study on the sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of 18F-NY104 PET/CT in diagnosing primary, recurrent, and metastatic lesions of renal cell carcinoma; and investigate the effect of oral low-dose CAIX inhibitor (Acetazolamide) on the tissue distribution of 18F-NY104 in renal cell carcinoma patients, particularly in the stomach and kidneys.

Eligibility

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria4

(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 as renal cell carcinoma or clinically diagnosed/suspected recurrence/metastasis after RCC treatment; (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:
Hematology: WBC ≥4.0×10⁹/L or neutrophils ≥1.5×10⁹/L, PLT ≥100×10⁹/L, Hb ≥90g/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 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; (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 Criteria9

Recovery from major trauma (including surgery) within 4 weeks prior to study examination;
Patients with systemic or local severe infections or other serious comorbidities;
Severe hepatic or renal dysfunction;
Refusal to participate in this clinical study;
Patients with a history of allergy to any component of the imaging agent (including antibodies) or allergic constitution;
Childbearing-aged male or female subjects who cannot adopt effective contraception;
Women planning pregnancy, currently pregnant, or lactating;
Patients unable or unwilling to undergo PET/CT scanning;
Other subjects deemed ineligible by the investigator.

Interventions

RADIATION18F-NY104 PET/CT

The radionuclide ¹⁸F will serve as the tracer in this study. NY104 will be labeled with \[¹⁸F\]AlF to form the ¹⁸F-NY104 injection for use in this research.All participants will undergo ¹⁸F-NY104 PET scan.