A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Microelastic Ultrasound Systems Inc2 sites in 1 country21 target enrollmentMay 26, 2022

ConditionsLymphedema of Upper Arm Breast Cancer

Overview

Phase: N/A
Intervention: Not specified
Conditions: Lymphedema of Upper Arm
Sponsor: Microelastic Ultrasound Systems Inc
Enrollment: 21
Locations: 2
Primary Endpoint: Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

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.

Registry

clinicaltrials.gov

Start Date

May 26, 2022

End Date

August 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Microelastic Ultrasound Systems Inc

Responsible Party

Sponsor

Eligibility Criteria

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