search
Back to results

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

Primary Purpose

Lymphedema of Upper Arm, Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Constructive Shearwave Interference (CSI)
Sponsored by
Microelastic Ultrasound Systems Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Lymphedema of Upper Arm

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Durham Regional Hospital
  • Duke University Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CSI ultrasound measurement

Arm Description

Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 28, 2022
Last Updated
September 5, 2023
Sponsor
Microelastic Ultrasound Systems Inc
Collaborators
Duke Health
search

1. Study Identification

Unique Protocol Identification Number
NCT05278871
Brief Title
Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Official Title
A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
May 26, 2022 (Actual)
Primary Completion Date
August 31, 2023 (Actual)
Study Completion Date
August 31, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Microelastic Ultrasound Systems Inc
Collaborators
Duke Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema of Upper Arm, Breast Cancer

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CSI ultrasound measurement
Arm Type
Experimental
Arm Description
Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.
Intervention Type
Device
Intervention Name(s)
Constructive Shearwave Interference (CSI)
Other Intervention Name(s)
Bullseye Elasticity Quantification
Intervention Description
handheld ultrasound
Primary Outcome Measure Information:
Title
Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs
Description
differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sarah Jo Stephens, MD
Organizational Affiliation
Duke Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham Regional Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26259888
Citation
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.
Results Reference
background

Learn more about this trial

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

We'll reach out to this number within 24 hrs