Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
1 other identifier
interventional
21
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2022
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 28, 2022
CompletedFirst Posted
Study publicly available on registry
March 14, 2022
CompletedStudy Start
First participant enrolled
May 26, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2023
CompletedDecember 13, 2023
December 1, 2023
1.3 years
February 28, 2022
December 12, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (1)
CSI ultrasound measurement
EXPERIMENTALParticipants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.
Interventions
handheld ultrasound
Eligibility Criteria
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.
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Microelastic Ultrasound Systems Inclead
- Duke Healthcollaborator
Study Sites (2)
Durham Regional Hospital
Durham, North Carolina, 27704, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
Related 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.
PMID: 26259888BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Susan McDuff, MD PhD
Duke Health
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 28, 2022
First Posted
March 14, 2022
Study Start
May 26, 2022
Primary Completion
August 31, 2023
Study Completion
August 31, 2023
Last Updated
December 13, 2023
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will not share