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.
Angiotensin-converting enzyme 1 (ACE1) has been reported to be aberrantly expressed in triple-negative breast cancer (TNBC) and may represent a potential molecular imaging target. BPP is an ACE1-targeting peptide, and our group has developed 68Ga-DOTA-BPP as a novel PET radiotracer for noninvasive visualization of ACE1 expression in vivo. This first-in-human study is designed to evaluate the safety, biodistribution, and tumor imaging characteristics of 68Ga-DOTA-BPP PET/CT in patients with confirmed or suspected TNBC. Participants will undergo 68Ga-DOTA-BPP PET/CT as well as 18F-FDG PET/CT. Visual and semiquantitative analyses will be used to characterize tracer uptake in tumor lesions and normal organs. In participants with available tumor tissue, the relationship between 68Ga-DOTA-BPP uptake and ACE1 expression assessed by immunohistochemistry will also be explored. The study is expected to provide preliminary clinical evidence regarding the feasibility of ACE1-targeted PET imaging for the noninvasive characterization of TNBC lesions and to support further clinical development of 68Ga-DOTA-BPP.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
20
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.
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.
Ethics Committee of Peking University Cancer Hospital
Beijing, Beijing Municipality, China
RECRUITINGSafety and tolerability of 68Ga-DOTA-BPP
Incidence and severity of adverse events following intravenous administration of68Ga-DOTA-BPP, assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0
Time frame: From 68Ga-DOTA-BPP administration through completion of the PET/CT imaging procedures on the same day
Biodistribution of 68Ga-DOTA-BPP in normal organs
Visual and semiquantitative PET/CT assessment of 68Ga-DOTA-BPP uptake and distribution in normal organs at the prespecified imaging time points.
Time frame: Within 2 hours after 68Ga-DOTA-BPP administration.
Detection of TNBC lesions by 68Ga-DOTA-BPP PET/CT
The detection rate of target lesions by 68Ga-DOTA-BPP PET/CT will be assessed using visual and semiquantitative image analysis.
Time frame: Within 2 hours after 68Ga-DOTA-BPP administration
Association between 68Ga-DOTA-BPP uptake and ACE1 expression
The relationship between tumor uptake of 68Ga-DOTA-BPP, including SUVmax, and ACE1 expression assessed by immunohistochemistry (e.g., H-score or IRS) will be evaluated in participants with available tumor tissue.
Time frame: Up to 2 months after PET/CT imaging
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