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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05278871
Other study ID # Pro00109917
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 26, 2022
Est. completion date August 31, 2023

Study information

Verified date December 2023
Source Microelastic Ultrasound Systems Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 21
Est. completion date August 31, 2023
Est. primary completion date August 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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


Intervention

Device:
Constructive Shearwave Interference (CSI)
handheld ultrasound

Locations

Country Name City State
United States Duke University Medical Center Durham North Carolina
United States Durham Regional Hospital Durham North Carolina

Sponsors (2)

Lead Sponsor Collaborator
Microelastic Ultrasound Systems Inc Duke Health

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lee SY, Cardones AR, Doherty J, Nightingale K, Palmeri M. Preliminary Results on the Feasibility of Using ARFI/SWEI to Assess Cutaneous Sclerotic Diseases. Ultrasound Med Biol. 2015 Nov;41(11):2806-19. doi: 10.1016/j.ultrasmedbio.2015.06.007. Epub 2015 Aug 8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb baseline
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