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Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
A Phase II, Single-center STudy on the vAlue of Non-invasive Dual-Pet（18F-FES PET and 68Ga-HER2-Affibody PET）InformatiOn IN Subtype of Metastatic Breast Cancer(MBC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic breast cancer patients | 50 metastatic breast cancer patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| biopsy or surgical pathology in metastases | Procedure | biopsy or surgical pathology in extrahepatic/liver/brain metastases |
|
| Measure | Description | Time Frame |
|---|---|---|
| Verify the subtype value of dual-PET in extrahepatic metastases | Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases. | 2 year |
| Measure | Description | Time Frame |
|---|---|---|
| Verify the HER2-PET value in liver metastasis | Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in liver metastasis. | 2 year |
| Verify the HER2-PET value in brain metastasis |
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Inclusion Criteria:
Exclusion Criteria:
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50 metastatic breast cancer patients
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xichun Hu, MD, PhD | Contact | 64175590 | 5006 | huxicun@gmail.com |
| Jian Zhang, M.D. | Contact | 64175590 | 85000 | syner2000@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Xichun Hu, MD, PhD | Fudan University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer Center Institutional Review Board | Recruiting | Shanghai | Shanghai Municipality | China |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D001706 | Biopsy |
| C043436 | 16-fluoroestradiol |
| ID | Term |
|---|---|
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| 68Ga-HER2 affibody,18F-FDG, 18F-FES | Drug | 68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical. |
|
Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis.
| 2 year |
| Heterogeneity in metastatic lesions | Observe the heterogeneity of ER and HER2 expression in metastatic lesions. | 2 year |
| D017437 |
| Skin and Connective Tissue Diseases |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |