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RECRUITING
NCT06916624

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

Sponsor: The Affiliated Hospital of Qingdao University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

OBSERVATIONAL

Enrollment

120

Start Date

2025-04-12

Completion Date

2027-12

Last Updated

2026-09-17

Healthy Volunteers

No

Interventions

RADIATION

18F-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.

Locations (1)

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China