Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer; Lymphedema of Upper Arm
• Interventions: Device: Constructive Shearwave Interference (CSI)

• Registration Number: NCT05278871
• Lead Sponsor: Microelastic Ultrasound Systems Inc

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-02-28
• Study First Submitted QC: 2022-03-09
• Study First Posted: 2022-03-14
• Study Start: 2022-05-26
• Primary Completion: 2023-08-31
• Study Completion: 2023-08-31
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-12
• Last Update Posted: 2023-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CSI ultrasound measurement	Constructive Shearwave Interference (CSI)	Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Durham Regional Hospital; 🇺🇸 Durham, North Carolina, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States