Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Completed · Not applicable

Conditions studied: Lymphedema of Upper Arm, Breast Cancer

In brief

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.

Key facts

Study ID

NCT05278871

Run by

Microelastic Ultrasound Systems Inc

People needed

21

Starts

2022-05-26

Expected to finish

2023-08-31

Last updated by the study team

2023-12-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Active rash or skin tears/injury in bilateral upper extremities
• Subjects with history of contralateral breast cancer treatment

Where it is running

• Durham Regional Hospital — Durham, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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