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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06900023
Status
Enrolling By Invitation

Conditions

  • Breast Edema
  • Breast Lymphedema
  • Lymphedema
  • Lymphedema, Breast Cancer

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
May 5, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Participants with breast edema: N=15
    This group will contain women who report breast edema and have been diagnosed with breast edema through clinical examination
  • Arm: Participants without breast edema: N=15
    These participants do not report a history of breast edema and do not have a history of breast edema.

Primary Outcome Measure

Tissue Dielectric Constant [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114-

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By research site
Massachusetts General Hospital· Boston, MA

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