Breast Cancer, Lymphedema of Upper Arm
Conditions
Brief summary
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.
Interventions
DEVICEConstructive Shearwave Interference (CSI)
handheld ultrasound
Sponsors
Duke Health
Microelastic Ultrasound Systems Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 must have completed all recommended adjuvant radiotherapy. Subjects who continue on systemic therapy may be included at the discretion of the treating physician. * 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
Exclusion criteria
* Active rash or skin tears/injury in bilateral upper extremities * Subjects with history of contralateral breast cancer treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs | baseline | differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb |
Countries
United States
Outcome results
None listed