Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
ConditionCancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University Cancer Hospital & Institute
About this trial
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.
Eligibility criteria
Qualifiers
Age 18 to 75 years, inclusive; sex unrestricted.
Patients with triple-negative breast cancer (TNBC) or suspected TNBC who are scheduled to undergo pathological tissue biopsy or surgical treatment for the tumor in the near future (within 2 months).
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Estimated life expectancy of ≥12 weeks.
Disqualifiers
Presence of any of the following conditions: brain metastases, except asymptomatic primary or metastatic brain tumors that do not require treatment; carcinomatous meningitis; myocardial infarction within 6 months prior to enrollment; unstable angina; high risk of uncontrolled arrhythmia; history of coronary artery bypass grafting; cerebrovascular accident within 6 months prior to enrollment; congestive heart failure (NYHA Class III-IV); pulmonary embolism; deep vein thrombosis; concurrent infection requiring intravenous antibiotic treatment within the previous 2 weeks; or receipt of immunosuppressive therapy following organ transplantation.
Primary central nervous system tumors.
HBV DNA ≥10⁴ copies/mL or ≥2,000 IU/mL.
HCV RNA ≥1,000 copies/mL.
Trial design
Treatments tested in this trial
- 68Ga-DOTA-BPP
- 18F-FDG
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov