Study on the Value of Non-invasive Dual-Pet Information in Subtype of Metastatic Breast Cancer

• Conditions: Breast Cancer
• Interventions: Procedure: biopsy or surgical pathology in metastases; Drug: 68Ga-HER2 affibody,18F-FDG, 18F-FES

• Registration Number: NCT04758416
• Lead Sponsor: Fudan University

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)

Study Timeline

• Study Start: 2020-12-31
• Study First Submitted: 2021-02-14
• Study First Submitted QC: 2021-02-14
• Study First Posted: 2021-02-17
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-19
• Last Update Posted: 2022-04-20
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 50

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Metastatic breast cancer patients	biopsy or surgical pathology in metastases	50 metastatic breast cancer patients
Metastatic breast cancer patients	68Ga-HER2 affibody,18F-FDG, 18F-FES	50 metastatic breast cancer patients

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
Heterogeneity in metastatic lesions	2 year	Observe the heterogeneity of ER and HER2 expression in metastatic lesions.

Trial Locations

Locations (1)

Shanghai Cancer Center Institutional Review Board; 🇨🇳 Shanghai, Shanghai, China