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NOT YET RECRUITING
NCT07875946
EARLY_PHASE1

68Ga- and 18F-CAIX PET Imaging Study

Sponsor: Peking University First Hospital

View on ClinicalTrials.gov

Summary

This exploratory clinical imaging study will evaluate the safety, tolerability, biodistribution, lesion detection, and tumor uptake characteristics of 68Ga- and 18F-labeled carbonic anhydrase IX (CAIX)-targeted positron emission tomography/computed tomography (PET/CT) in patients with renal tumors or suspected renal cell carcinoma. Participants will be randomly assigned to receive either 68Ga-CAIX or 18F-CAIX PET/CT. All participants will also undergo 18F-FDG PET/CT for comparison. The study will further explore the association between CAIX-targeted PET findings and CAIX expression assessed by immunohistochemistry, as well as the diagnostic performance of CAIX-targeted PET/CT for lesion detection.

Official title: A Prospective Randomized Study of 68Ga- and 18F-Labeled CAIX-Targeted PET/CT Imaging in Patients With Renal Tumors

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2026-10-01

Completion Date

2028-12-31

Last Updated

2026-10-15

Healthy Volunteers

Yes

Interventions

DRUG

68Ga-CAIX PET/CT

68Ga-labeled CAIX-targeted PET tracer administered as a single intravenous injection at approximately 0.08-0.10 mCi/kg, followed by PET/CT imaging approximately 1 hour after administration.

DRUG

18F-CAIX

18F-labeled CAIX-targeted PET tracer administered as a single intravenous injection at approximately 0.08-0.10 mCi/kg, followed by PET/CT imaging approximately 1 hour after administration.

Locations (1)

Department of Nuclear Medicine, Peking University First Hospital

Beijing, Beijing Municipality, China