Novel MRI Techniques on Evaluation of Lymphedema
ConditionLymphedema of Upper Limb
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
In this project, the investigators aim to investigate the imaging approaches for breast cancer-related secondary lymphedema. The clinical study aims to optimize the conventional MRI methods for mapping lymphedema and assess the post-surgical therapeutic effects in longitudinal follow-up studies. Additionally, a normal imaging database of lymphedema MRI images will be established for future reference. For pre-clinical animal study, investigators aim to develop and integrate two novel MRI methods, including free water elimination diffusion MRI and diffusion kurtosis MRI techniques. By integrating clinical and pre-clinical studies, the investigators aim to establish a precise imaging tool for evaluating the therapeutic effects of lymphedema for following translational applications.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
adults with breast cancer related lymphedema
Disqualifiers
children younger than 20 years old
pregnancy
The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.
Metallic intraocular foreign bodies.
Trial population
adults with breast cancer related lymphedema
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Diffusion magnetic resonance imaging
Procedure/SurgeryFree water elimination diffusion MRI and diffusion kurtosis MRI techniques
Treatment groups
210 Participants
are divided into 1 treatment groupGroup A: Breast cancer related lymphedema1 intervention
Trial outcomes
Primary outcomes
1
change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
circumference in cm
Time frame
baseline, 3 months after lymphaticovenous anastomosis2
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis
volume in mL
Time frame
baseline, 3 months after lymphaticovenous anastomosisSponsors and contacts
Click on the lead sponsor to view all of their trials.
National Taiwan University Hospital
Lead sponsor
National Health Research Institutes, Taiwan
Collaborator
Source ClinicalTrials.gov