Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT04758416|
Recruitment Status : Recruiting
First Posted : February 17, 2021
Last Update Posted : February 21, 2021
|Condition or disease||Intervention/treatment|
|Breast Cancer||Procedure: biopsy or surgical pathology in metastases Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||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)|
|Actual Study Start Date :||December 31, 2020|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Metastatic breast cancer patients
50 metastatic breast cancer patients
Procedure: biopsy or surgical pathology in metastases
biopsy or surgical pathology in extrahepatic/liver/brain metastases
Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES
68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
- Verify the subtype value of dual-PET in extrahepatic metastases [ Time Frame: 2 year ]Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases.
- Verify the HER2-PET value in liver metastasis [ Time Frame: 2 year ]Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in liver metastasis.
- Verify the HER2-PET value in brain metastasis [ Time Frame: 2 year ]Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis.
- Heterogeneity in metastatic lesions [ Time Frame: 2 year ]Observe the heterogeneity of ER and HER2 expression in metastatic lesions.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04758416
|Contact: Xichun Hu, MD, PhD||64175590 ext email@example.com|
|Contact: Jian Zhang, M.D.||64175590 ext firstname.lastname@example.org|
|Shanghai Cancer Center Institutional Review Board||Recruiting|
|Shanghai, Shanghai, China|
|Contact: Xichun Hu, MD, PhD 64175590 ext 5006 email@example.com|
|Principal Investigator:||Xichun Hu, MD, PhD||Fudan University|