Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05278871
• Other study ID #: Pro00109917
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lymphedema
• Lymphedema of Upper Arm

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