Breast Cancer Clinical Trial

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

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.

View Eligibility Criteria

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 will have completed all recommended adjuvant radiotherapy and/or chemotherapy prior to study entry.
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 is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05278871

Recruitment Status:

Recruiting

Sponsor:

Microelastic Ultrasound Systems Inc

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There are 2 Locations for this study

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Durham Regional Hospital
Durham North Carolina, 27704, United States More Info
Taylor Fryman
Contact
919-668-3726
[email protected]
Duke University Medical Center
Durham North Carolina, 27710, United States More Info
Taylor Fryman, BS
Contact
919-668-3726
[email protected]
Joan Cahill, BSN OCN CCRP
Contact
(919) 668-5211
[email protected]

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

30

Study ID:

NCT05278871

Recruitment Status:

Recruiting

Sponsor:


Microelastic Ultrasound Systems Inc

How clear is this clinincal trial information?

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