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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-DOTA-BPP | 68Ga-DOTA-BPP PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 68Ga-DOTA-BPP, a Siemens Biograph PET/CT scan will be applied within 1 h-2 h, and the scan range will be from the top of the head to 1/3 of the upper thigh. | ||
| 18F-FGD | 18F-FDG PET/CT: after intravenous injection of 2.96 MBq/ kg body weight of quality-controlled 18F-FDG, a Siemens Biograph PET/CT scan will be applied within 1 h, and the scan range will be from the top of the head to 1/3 of the upper thigh. |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual assessment of lesions | Visual analysis of 68Ga-DOTA-BPP PET images will be performed by consensus reading by at least 2 experienced nuclear medicine physician | 1 year |
| Semiquantitative assessment of lesions | The standardized uptake values (SUVs) of 68Ga-DOTA-BPP in lesions will be measured by the same nuclear medicine physician for all the cases | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| ACE expression analysis of tumor tissues | Tumor tissues obtained from biopsy or surgery will be stained for ACE | 1 year |
| Correlation analysis of 68Ga-DOTA-BPP uptake and lesion size changes | The SUVs of 68Ga-DOTA-BPP in individual lesions will be compared to the changes in lesion sizes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients at Being Cancer Hospital who are confirmed TNBC.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qian Zhang | Contact | 13765839835 | 1806708691@qq.com | |
| Hua Zhu, M.D | Contact | 13671224863 | zhuhuabch@pku.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ethics Committee of Peking University Cancer Hospital | Recruiting | Beijing | Beijing Municipality | 100142 | China |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 1 year |