NCT05278871CompletedNot Applicable
A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Microelastic Ultrasound Systems Inc4 sites in 1 country21 target enrollmentStarted: May 26, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 21
- Locations
- 4
- Primary Endpoint
- Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
Outcomes
Primary Outcomes
Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
Time Frame: baseline
differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (4)
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