Breast Cancer Clinical Trial
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
This proof of concept study will evaluate the ability of a new, ultrasound based technology called Bullseye Constructive Shearwave Interference (CSI) (trade name, Bullseye Elasticity Quantification) to measure lymphedema of the upper arm among breast cancer survivors.
The study's hypothesis is that the CSI device can detect the presence of clinically significant lymphedema when compared with the standard arm tape measurement.
Any subject with a history of unilateral breast cancer who has completed definitive treatment for breast cancer (i.e. previously undergone surgical resection, with or without adjuvant radiotherapy and/or chemotherapy). Subjects will have completed all recommended adjuvant radiotherapy and/or chemotherapy prior to study entry.
Subjects with a history of unilateral axillary sentinel biopsy, lymphadenectomy or dissection are eligible for inclusion.
Subjects taking hormonal therapy are eligible for inclusion
Subject has any stage lymphedema
Active rash or skin tears/injury in bilateral upper extremities
Subjects with history of contralateral breast cancer treatment
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