Breast Cancer
Conditions
Keywords
Breast Cancer
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.
Interventions
OTHERBreast Cancer-Related Lymphedema Measurements
All patients will receive bilateral arm measurements using the LymphaTech Scanner and the Perometer.
Sponsors
Massachusetts General Hospital
Heinz Family Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This is an interventional, non-therapeutic screening trial comparing two measurement devices cross-sectionally.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Precision and reliability | 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
| Measure | Time frame | Description |
|---|---|---|
| Measurement Time | 3 years | To evaluate amount of time it takes to conduct bilateral arm measurements with both the LymphaTech Scanner and Perometer. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAlphonse G. Taghian, MD
Dana-Farber Cancer Institute
Outcome results
None listed