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Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

NCT ID: NCT05278871

Last Updated: 2023-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-26

Study Completion Date

2023-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Lymphedema of Upper Arm Breast Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Constructive Shearwave Interference (CSI)

Intervention Type DEVICE

handheld ultrasound

Interventions

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Constructive Shearwave Interference (CSI)

handheld ultrasound

Intervention Type DEVICE

Other Intervention Names

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Bullseye Elasticity Quantification

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke Health

OTHER

Sponsor Role collaborator

Microelastic Ultrasound Systems Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Susan McDuff, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Duke Health

Locations

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Durham Regional Hospital

Durham, North Carolina, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 26259888 (View on PubMed)

Other Identifiers

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Pro00109917

Identifier Type: -

Identifier Source: org_study_id