Multi-Parametric Assessment of Breast Lymphedema
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|ClinicalTrials.gov Identifier: NCT02724514|
Recruitment Status : Recruiting
First Posted : March 31, 2016
Last Update Posted : September 25, 2018
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.
|Condition or disease||Intervention/treatment|
|Breast Cancer Breast Lymphedema||Other: non-invasive image & bioimpedance based techniques|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Multi-Parametric Assessment of Breast Lymphedema|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||November 2016|
|Estimated Study Completion Date :||December 2019|
- Other: non-invasive image & bioimpedance based techniques
Ultrasound scans, bioimpedance measurements, clinical photographs and questionnaires will be performed before and after the massage.
- Measure Mid-Band Fit (MBF) in normal tissue controls and the corresponding regions of lymphedema [ Time Frame: 2 years ]The MBF, measured in dB, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
- Measure Acoustic Scatterer Diameter (ASD) in normal tissue controls and the corresponding regions of lymphedema [ Time Frame: 2 years ]The ASD, measured in mm, is a quantitative ultra-sound (QUS) image parameter used to characterize tissue microstructure
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02724514
|Contact: Robert Dinniwell, MD||416 946 4501 ext 4662||Rob.Dinniwell@rmp.uhn.on.ca|
|Princess Margaret Cancer Centre||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Robert Dinniwall, MD||UHN|