By InvitationNot Applicable

The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer

United States30 participantsStarted 2025-05-05

Plain-language 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 to study how well two tools (tissue dielectric constant and ultrasound) measure breast edema after breast conserving surgery for breast cancer. Participants who agree to be in the study will be asked to come in for one appointment of approximately two hours. All data will be collected during this one visit. Participants will be asked to fill out two questionnaires regarding their symptoms, and one questionnaire regarding their surgical scar. The research staff will conduct a clinical examination, measure breast edema using ultrasound and tissue dielectric constant, measure arm volume with the perometer and fluid with the SOZO, and take photographs of both breasts.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Tissue Dielectric Constant

Timeframe: Baseline

Breast Ultrasound

Timeframe: Baseline

Trial details

NCT IDNCT06900023

SponsorMassachusetts General Hospital

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12