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Trials / Enrolling By Invitation

Enrolling By InvitationNCT06900023

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

Status
Enrolling By Invitation
Phase
Study type
Observational
Enrollment
30 (estimated)
Sponsor
Massachusetts General Hospital · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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.

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) identify breast edema after breast conserving surgery for breast cancer. Participants will be asked to attend one appointment in which all data will be collected. This will include questionnaires regarding symptoms, clinical examination, measurement of breast edema using two tools (ultrasound and tissue dielectric constant), measurement with the perometer and SOZO, and clinical photographs.

Conditions

Timeline

Start date
2025-05-05
Primary completion
2026-12-01
Completion
2027-12-01
First posted
2025-03-28
Last updated
2025-07-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT06900023. Inclusion in this directory is not an endorsement.