Status:
ACTIVE_NOT_RECRUITING
Exploring the Efficacy and Feasibility of the LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Heinz Family Foundation
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
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 br...
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 comp...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2026
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03861975
Start Date
January 30 2019
End Date
May 30 2026
Last Update
December 15 2025
Active Locations (1)
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1
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114