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

Mass General Brigham

Status

Invitation-only

Conditions

Breast Edema

Lymphedema, Breast Cancer

Breast Lymphedema

Lymphedema

Study type

Observational

Funder types

Other

Identifiers

NCT06900023

23412

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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