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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03861975
• Other study ID #: 18-181
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2019
• Est. completion date: May 30, 2026

Study information

• Verified date: March 2024
• Source: Massachusetts General Hospital
• Contact: Alphonse G. Taghian, MD
• Phone: 617-724-4000
• Email: ataghian[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: May 30, 2026
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Cancer Lymphedema
• Breast Neoplasms
• Lymphedema

Intervention

Other:
• Breast Cancer-Related Lymphedema Measurements
All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital Cancer Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Heinz Family Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Precision and reliability	To determine whether the LymphaTech scanner is a precise and reliable tool for measuring upper extremity volume changes in patients treated for breast	3 years
Secondary	Measurement Time	To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer.	3 years