Status:
COMPLETED
Imaging Biomarkers of Lymphatic Dysfunction
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
National Institutes of Health (NIH)
National Institute of Nursing Research (NINR)
Conditions:
Secondary Lymphedema
Eligibility:
FEMALE
30-90 years
Phase:
NA
Brief Summary
Persons with secondary arm and/or upper quadrant lymphedema following cancer therapies commonly are prescribed complete decongestive therapy as a course of management of their lymphedema. The investig...
Detailed Description
The goal of this work is to apply novel, noninvasive magnetic resonance imaging (MRI) methods for visualizing lymphatic circulation dysfunction to test a fundamental hypothesis about secondary lymphed...
Eligibility Criteria
Inclusion
- Females with a diagnosis of secondary arm and/or upper quadrant lymphedema following cancer treatments
Exclusion
- Subjects who have any type of non-MRI compatible bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulators, electronic infusion pumps, etc.) or are not able to comfortably be able to tolerate the limited fit of the MRI
- Subjects who have any type of ferromagnetic bioimplant that could potentially be displaced.
- Subjects who may have shrapnel embedded in their bodies (such as from war wounds), metal workers and machinists (potential for metallic fragments in or near the eyes).
- Pregnant women will be excluded from the MRI portion of the study only
- Subjects who have open wounds on either ankle or top of foot because of contraindications with placement of electrodes to obtain the L-DEX U400 readings.
- Persons with heart pacemakers.
- Persons with bilateral arm lymphedema (or bilateral risk) or pre-existing lymphedema/edema in the upper body prior to cancer treatments.
Key Trial Info
Start Date :
January 23 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 15 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT03760744
Start Date
January 23 2019
End Date
March 15 2025
Last Update
October 16 2025
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212