PET Scan Tracer Test for Kidney Cancer Detection

Trial details

Who runs it

The Affiliated Hospital of Qingdao University

Trial code

NCT06916624

Record updated

17 September 2026

Original description

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.Read full original descriptionShow less

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

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.

Inclusion: 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.

Exclusion: Recovery from major trauma (including surgery) within 4 weeks prior to study examination; 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; Childbearing-aged male or female subjects who cannot adopt effective contraception; 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.

ClinicalTrials.gov NCT06916624