Breast Cancer
Conditions
Brief summary
Study on the Value of Non-invasive Dual-Pet(18F-FES PET and 68Ga-HER2-Affibody PET) Information in Subtype of Metastatic Breast Cancer
Detailed description
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)
Interventions
PROCEDUREbiopsy or surgical pathology in metastases
biopsy or surgical pathology in extrahepatic/liver/brain metastases
DRUG68Ga-HER2 affibody,18F-FDG, 18F-FES
68Ga-NOTA-MAL-MZHER2 (68Ga-HER2) affibody is an investigational Positron Emission Tomography (PET)/ Computed Tomography (CT) radiopharmaceutical.
Sponsors
Fudan University
Study design
Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
MALE
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects voluntarily joined the study, signed informed consent, and had good compliance. 2. Female patients aged over 18 years (including cutoff value). 3. an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 4. Recurrence or metastatic breast cancer confirmed by histopathology, or expect to be feasible metastasis puncture or surgery to confirm histopathological recurrence or metastatic breast cancer.
Exclusion criteria
1. Pregnancy or lactation. 2. Alcohol allergy is not suitable for FES-PET/ C. 3. There are contraindications for patients who are expected to have metastasis puncture or surgery. 4. Mental disorders or other conditions affecting patient compliance.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Verify the subtype value of dual-PET in extrahepatic metastases | 2 year | Verify whether the subtype value of FES-PET and HER2-PET is consistent with biopsy or surgical pathology in extrahepatic metastases. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Verify the HER2-PET value in liver metastasis | 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 | 2 year | Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis. |
| Heterogeneity in metastatic lesions | 2 year | Observe the heterogeneity of ER and HER2 expression in metastatic lesions. |
Countries
China
Contacts
Primary ContactXichun Hu, MD, PhD
Backup ContactJian Zhang, M.D.
Outcome results
None listed