Construction and Clinical Translation of ACE Targeted Nuclear Medicine Imaging Probe
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
Primary outcome measures
- The biosafety, tolerability, and normal biodistribution characteristics of the 68Ga-DOTA-BPP tracer in patients with TNBC [Time frame: 1 year]
Secondary outcome measures (1)
- The detection rate of 68Ga-DOTA-BPP PET/CT for target lesions in TNBC, and its concordance with the results of 18F-FDG PET/CT and immunohistochemistry (IHC). [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Ethics Committee of Peking University Cancer Hospital — Beijing
Identifiers
NCT: NCT06203119 · 2023KT160