Status:
ENROLLING_BY_INVITATION
The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Breast Edema
Breast Lymphedema
Eligibility:
FEMALE
18+ years
Brief Summary
The goal of this observational study is to learn if participants agree to take part in the study, if the methods we are using for the study are feasible for the participants and the researchers, and t...
Detailed Description
The goal of this observational study is to learn if the study protocol is feasible, if we can accrue participants easily, and to determine how well two tools (tissue dielectric constant and ultrasound...
Eligibility Criteria
Inclusion
- All participants must meet the following inclusion criteria:
- Be a female between the ages of 18 and 85 years.
- Have undergone breast conserving surgery +/- LN removal (sentinel lymph node biopsy (SLNB) or axillary lymph node dissection (ALND)
- Have no residual cancer in the breast after definitive breast surgery
- Have been treated with radiation therapy and have completed breast cancer treatment (excluding Herceptin and hormonal treatments) at MGH greater than or equal to 3 months ago.
- Be able to read and understand English
- Understand the proposed study and be willing and fully able to comply with the study procedures
- Be a willing participant and be capable of giving and has given informed written consent for entry into the study
- EXCLUSION CRITERIA
- Participants will be excluded if they:
- Have bilateral BC
- Have metastatic or inflammatory BC
- Will be excluded from the SOZO measurement of the study if they have implanted cardiac devices or neurostimulators
- Have any medical condition that may result in breast swelling;
- Uncontrolled congestive cardiac failure,
- Arteriovenous haemodialysis,
- Current infection or cellulitis of either breast.
- Be pregnant or currently breast feeding.
- Have a known over-active thyroid or known benign thyroid tumour
Exclusion
Key Trial Info
Start Date :
May 5 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06900023
Start Date
May 5 2025
End Date
December 1 2027
Last Update
July 16 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114