Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening

Mass General Brigham

Status: Active, not recruiting

Conditions: Breast Cancer

Treatments: Other: Breast Cancer-Related Lymphedema Measurements

Study type: Interventional

Funder types: Other

Identifiers

NCT03861975

18-181

Details and patient eligibility

About

This research will compare the absolute volumes of the upper extremity using both the LymphaTech Scanner and Perometer in a cohort of patients with a history of invasive or in-situ carcinoma of the breast.

Full description

Our trial seeks to assess the efficacy of the LymphaTech Scanner as compared to the Perometer, which is currently used to screen for breast cancer-related lymphedema. The focus of the study is to compare the absolute volumes of the upper-extremity as measured by each device and to compare the time it takes to measure both arms of a patient using each device to assess clinical feasibility.

Enrollment: 100 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and will undergo unilateral breast cancer surgery
• Age >18 years.
• Ability to understand and the willingness to verbally consent to the trial

Exclusion criteria

• History of primary lymphedema.
• Any patient with a current case of cellulitis.
• Participants with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
• Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
• Participants unable to abduct upper-extremity perpendicular to body or to stand comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech Scan

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Breast Cancer-Related Lymphedema Measurements

Experimental group

Description:

Absolute volume of the upper extremities will be assessed using the LymphaTech Scanner and the Perometer.

Treatment:

Other: Breast Cancer-Related Lymphedema Measurements