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RECRUITING
NCT06203119
PHASE1

Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe

Sponsor: Peking University Cancer Hospital & Institute

View on ClinicalTrials.gov

Summary

This prospective, single-center, open-label study aims to evaluate the safety, biodistribution, and tumor imaging characteristics of the novel ACE1-targeted PET radiotracer 68Ga-DOTA-BPP in patients with confirmed or suspected triple-negative breast cancer (TNBC). Participants will undergo \^68Ga-DOTA-BPP PET/CT and 18F-FDG PET/CT. Visual and semiquantitative imaging analyses will be performed to assess tracer uptake in tumor lesions and normal organs. The relationship between \^68Ga-DOTA-BPP uptake and ACE1 expression will also be explored in participants with available tumor tissue.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2024-03-06

Completion Date

2026-12-02

Last Updated

2026-08-21

Healthy Volunteers

No

Conditions

Interventions

DRUG

68Ga-DOTA-BPP

68Ga-DOTA-BPP is an ACE1-targeted PET radiotracer. After intravenous administration of 3-5 mCi of quality-controlled 68Ga-DOTA-BPP, PET/CT imaging will be performed to evaluate the safety, biodistribution, and tumor imaging characteristics of the tracer in patients with confirmed or suspected triple-negative breast cancer.

DRUG

18F-FDG

Participants will receive an intravenous injection of 18F-FDG at 0.1-0.15 mCi/kg after fasting for at least 6 hours. Whole-body PET/CT imaging will be performed approximately 1 hour after injection.

Locations (1)

Ethics Committee of Peking University Cancer Hospital

Beijing, Beijing Municipality, China