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LymphaTech Scanner for Breast Cancer-Related Lymphedema Screening

Trial Status: Active

This trial investigates how well the LymphaTech scanner works for early detection of breast cancer-related lymphedema compared to perometry. Breast cancer-related lymphedema is characterized by an abnormal build up of protein-rich fluid in the interstitial tissues due to improper drainage within the lymphatic system. This build up may cause swelling of the arm, trunk, breast, and / or shoulder in the side treated for breast cancer. LymphaTech scanner may help doctors find breast cancer-related lymphedema sooner, when it may be easier to treat.

Inclusion Criteria

  • Participants must have histologically or cytologically confirmed invasive or in-situ carcinoma of the breast and have undergone breast cancer surgery
  • 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 comfortably without aid for several minutes, both of which are necessary to perform a LymphaTech scan

Massachusetts

Boston
Massachusetts General Hospital Cancer Center
Status: ACTIVE
Contact: Alphonse G. Taghian

PRIMARY OBJECTIVE:

I. To determine whether the LymphaTech scanner is a valid tool for early detection of breast cancer-related lymphedema (BCRL) when compared to perometry.

SECONDARY OBJECTIVE:

I. To compare the time it takes to conduct bilateral arm measurements using the LymphaTech scanner and Perometer.

OUTLINE:

Patients undergo arm measurement with perometry and the LymphaTech scanner on the same day.

Trial Phase Phase O

Trial Type Screening

Lead Organization
Dana-Farber Harvard Cancer Center

Principal Investigator
Alphonse G. Taghian

  • Primary ID 18-181
  • Secondary IDs NCI-2020-03809
  • Clinicaltrials.gov ID NCT03861975