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ACTIVE NOT RECRUITING
NCT07875244
NA

MAMMI-BB PET for Monitoring Response to Neoadjuvant Therapy in Breast Cancer

Sponsor: Fudan University

View on ClinicalTrials.gov

Summary

This prospective, single-center, open-label, single-arm study will evaluate MAMMI-BB positron emission tomography (PET) for monitoring response to neoadjuvant therapy in patients with breast cancer and baseline axillary lymph node involvement. Serial PET examinations will measure changes in maximum standardized uptake value (SUVmax) in breast lesions and axillary lymph nodes. These changes will be compared with surgical pathology to assess their ability to predict pathologic complete response separately in the breast and axilla and to identify the most informative assessment time point. Associations between PET parameters and long-term outcomes, including progression-free survival and disease-free survival, will also be explored.

Official title: A Prospective Study Evaluating MAMMI-BB (Biplanar Breast) PET for Serial Monitoring of Response to Neoadjuvant Therapy in Breast Cancer

Key Details

Gender

FEMALE

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

1024

Start Date

2019-06-27

Completion Date

2027-05

Last Updated

2026-10-15

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Serial MAMMI-BB PET Imaging

Serial fluorine-18 fluorodeoxyglucose (18F-FDG) PET imaging of the breast and axilla using MAMMI-BB PET. Participants fast for at least 4 hours, undergo blood glucose and body weight measurements, and receive intravenous 18F-FDG. Imaging begins approximately 60 minutes after injection. Breast imaging is performed in the prone position, followed by axillary imaging in the standing position with the arm supported. SUVmax is measured separately in breast lesions and axillary lymph nodes at four planned assessment time points.

Locations (1)

Fudan University Shanghai Cancer Center

Shanghai, China