Multi-Parametric Assessment of Breast Lymphedema

Study Overview
=================
Brief Summary
-----------------
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Unlike lymphedema in the arm, breast lymphedema is not as well-known and has not been studied. At present, no objective and standardized tools exist to evaluate breast lymphedema. The purpose of this study is to investigate the use of ultrasound analysis and bio-impedance to determine if it is possible to measure the extent of the fluid in the breast.

Detailed Description
-----------------
Breast lymphedema (swelling due to fluid) is a common complication of breast cancer therapy. Limited research has been conducted on the frequency of breast lymphedema with most studies reporting the incidence as ranging from 33 to 48%. Women with breast lymphedema describe breast fullness, heaviness and pain associated with breast swelling and changes that impacts how the breast looks (cosmesis) and also impacts their quality of life. At present, no objective and standardized tools exist to evaluate breast lymphedema and correlate it with tissue fluid and fibrosis, and their relationships to local symptoms, cosmesis and quality of life. The goal of the study is to assess and compare photographic, ultrasound and the breast composition in newly diagnosed breast lymphedema, and to assess the use of breast massage to manage breast lymphedema. Developing non-invasive image-based methods may enable researchers to map the extent of lymphedema, monitor its progression and evaluate therapies. This may allow for improved quantitate measures to be undertaken to better assess future strategies intended to prevent or improve the management of this treatment complication. Patients participating in this study will have ultrasound scans before and after the massage. They will also be asked to complete a questionnaire.

Official Title
-----------------
Multi-Parametric Assessment of Breast Lymphedema

Conditions
-----------------
Breast Cancer, Breast Lymphedema

Intervention / Treatment
-----------------
* Other: non-invasive image & bioimpedance based techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 y/o Diagnosis of lymphedema involving the breast Diagnosis of in-situ or invasive breast cancer Female patients following breast conserving therapy and radiotherapy Spoken and written fluency in English; and Able to provide informed consent Exclusion Criteria: Pacemaker or implanted stimulator or other contraindication to bioimpedance analysis Prior breast surgery on the contra lateral breast Presence of active cellulitis within the breast, trunk or arm and Presence of active cancer

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: non-invasive image & bioimpedance based techniques|Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema | The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure | 2 years | 
| Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema | The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure | 2 years |