The BEACON Trial: Diagnostic Tools for Breast Lymphedema After Treatment for Breast Cancer (NCT06900023) | Clinical Trial Compass
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 range
18 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.