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Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05278871
Recruitment Status : Recruiting
First Posted : March 14, 2022
Last Update Posted : June 1, 2022
Sponsor:
Collaborator:
Duke Health
Information provided by (Responsible Party):
Microelastic Ultrasound Systems Inc

Study Description
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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.


Condition or disease Intervention/treatment Phase
Lymphedema of Upper Arm Breast Cancer Device: Constructive Shearwave Interference (CSI) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Pilot Study of Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors
Actual Study Start Date : May 26, 2022
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: CSI ultrasound measurement
Participants will have standard volumetric tape measurement across multiple arm locations for lymphedema followed by CSI ultrasound measurements of the same anatomic sites.
 Device: Constructive Shearwave Interference (CSI)
handheld ultrasound
Other Name: Bullseye Elasticity Quantification


Outcome Measures
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Primary Outcome Measures :
  1. Difference in mean shear wave speed across sites measured between lymphedema and non-lymphedema limbs [ Time Frame: baseline ]
    differences in shear wave speed (Bullseye) device measurements between lymphedema affected and non-affected contralateral limb


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05278871


Contacts
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Contact: Joan Cahill, BNS RN OCN CCRP (919) 668-5211 Joan.Cahill@duke.edu

Locations
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United States, North Carolina
Durham Regional Hospital Recruiting
Durham, North Carolina, United States, 27704
Contact: Taylor Fryman    919-668-3726    Taylor.Fryman@duke.edu   
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Taylor Fryman, BS    919-668-3726    Taylor.Fryman@duke.edu   
Contact: Joan Cahill, BSN OCN CCRP    (919) 668-5211    Joan.Cahill@duke.edu   
Sponsors and Collaborators
Microelastic Ultrasound Systems Inc
Duke Health
Investigators
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Principal Investigator: Susan McDuff, MD PhD Duke Health
More Information
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Publications:

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Responsible Party: Microelastic Ultrasound Systems Inc
ClinicalTrials.gov Identifier: NCT05278871    
Other Study ID Numbers: Pro00109917
First Posted: March 14, 2022    Key Record Dates
Last Update Posted: June 1, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Lymphedema
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Lymphatic Diseases