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

Breast Cancer Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04758416
• Other study ID #: STANDPOINT
• Status: Recruiting
• Start date: December 31, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: April 2022
• Source: Fudan University
• Contact: Xichun Hu, MD, PhD
• Phone: 64175590
• Email: huxicun[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Shanghai Cancer Center Institutional Review Board	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Fudan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Verify the HER2-PET value in brain metastasis	Verify whether the HER2-PET value is consistent with biopsy or surgical pathology in brian metastasis.	2 year
Secondary	Heterogeneity in metastatic lesions	Observe the heterogeneity of ER and HER2 expression in metastatic lesions.	2 year