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Completed

NCT Number: NCT05278871

Noninvasive Assessment of Lymphedema Among Breast Cancer Survivors

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.

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Key information

Conditions

Lymphedema of Upper Arm Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Constructive Shearwave Interference (CSI)

Device

handheld ultrasound

Other names: Bullseye Elasticity Quantification

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Microelastic Ultrasound Systems Inc

Industry

Collaborators

  • Duke Health

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Mar 14, 2022
Registry last updated
Dec 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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