Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
- Conditions
- Cancer
- Registration Number
- NCT06203119
- Lead Sponsor
- Peking University Cancer Hospital & Institute
- Brief Summary
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the clinical predictive value of 68Ga-DOTA-BPP in subjects with triple-negative breast cancer. The visual and semiquantitative methods will be used to assess the PET/CT images
- Detailed Description
ACE is expressed in triple-negative breast cancer cells. This project develops new type of 68GA-labeled DOTA-BPP, leveraging the inherent strengths of this nuclear medicine discipline, promoted the formulation of the production of this drug To obtain 68Ga-DOTA-BPP injection that can be used in preclinical studies and meets clinical standards. Join a group In clinical patients, 68Ga-DOTA-BPP PET/CT imaging of patients with ACE-positive TNBC was performed, and ACE was obtained To provide evidence for patient screening and efficacy evaluation before targeted therapy with high expression of TNBC, and preliminatively evaluate the level of ACE against high level of ACE. The effect of tumor development can provide a practical basis for the establishment of ACE-targeted PET imaging platform
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
- 18-75 years old;
- ECOG score 0 or 1 point;
- Participants with confirmed TNBC cancer who are suggested by the clinicians to conduct PET/CT imaging for tumor diagnosis or staging.
- Pregnant or nursing;
- Severe hepatic or renal dysfunction;
- Low WBC (less than 3 x 10^9/L);
- Unable to comply with the PET/CT imaging procedures
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Semiquantitative assessment of lesions 1 year The standardized uptake values (SUVs) of 68Ga-DOTA-BPP in lesions will be measured by the same nuclear medicine physician for all the cases
Visual assessment of lesions 1 year Visual analysis of 68Ga-DOTA-BPP PET images will be performed by consensus reading by at least 2 experienced nuclear medicine physician
- Secondary Outcome Measures
Name Time Method ACE expression analysis of tumor tissues 1 year Tumor tissues obtained from biopsy or surgery will be stained for ACE
Correlation analysis of 68Ga-DOTA-BPP uptake and lesion size changes 1 year The SUVs of 68Ga-DOTA-BPP in individual lesions will be compared to the changes in lesion sizes
Trial Locations
- Locations (1)
Ethics Committee of Peking University Cancer Hospital
🇨🇳Beijing, Beijing, China