Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Precision and reliability
Overview
Brief Summary
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.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Screening
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Precision and reliability
Time Frame: 3 years
To determine whether the LymphaTech scanner is a precise and reliable tool for measuring upper extremity volume changes in patients treated for breast
Secondary Outcomes
- Measurement Time(3 years)
Investigators
Alphonse Taghian
Principal Investigator
Massachusetts General Hospital