Novel MRI Techniques on Evaluation of Lymphedema

Study Overview
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Brief Summary
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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.

Detailed Description
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A total of three sub-projects will be conducted in this project. Sub-project 1 will establish a pre-clinical rat model for lymphedema and develop novel MRI methods, including diffusion kurtosis MRI and free water elimination diffusion MRI techniques, for mapping tissue characteristics of lymphedema. Sub-project 1 will be complemented with the clinical images provided by sub-project 2, yielding more information about the lymphedema. Sub-project 2 aims to optimize the clinical MRI methods for mapping lymphedema and quantitatively assess the severity of lymphedema. A normal imaging database will be established for reference. Sub-project 2 and sub-project 3 will be complementary in co-developing the image assessment of post-surgical therapeutic effect. Sub-project 3 will quantitatively evaluate the severity of lymphedema secondary to different kinds of axillary treatments by using the clinical MRI methods for establishing longitudinal monitoring and prediction approaches. It also focuses on the pre-surgical and post-surgical evaluation of lymphedema undergone supermicrosurgical technique by using the clinical MRI methods.

Official Title
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Development and Optimization of Novel MRI Techniques on Evaluation of Therapeutic Effects for Lymphedema Secondary to Breast Cancer Treatment: An Integrated Study of Pre-clinical Animal Models and Clinical Follow-up

Conditions
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Lymphedema of Upper Limb

Intervention / Treatment
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* Procedure: Diffusion magnetic resonance imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults with breast cancer related lymphedema Exclusion Criteria: children younger than 20 years old pregnancy patients who have absolute contraindications regarding MRI scanning: The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices. Metallic intraocular foreign bodies. Implantable neurostimulation systems Cochlear implants/ear implant: bone-anchored hearing aid (BAHA) cochlear implant type can be scanned on a 1.5-tesla scanner only after the patient removes the battery. Cochlear implant wrapping scheduling must take place before the patient's MRI appointment. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the patient has to remove the device. Catheters with metallic components (Swan-Ganz catheter) Metallic fragments such as bullets, shotgun pellets, and metal shrapnel Cerebral artery aneurysm clips Magnetic dental implants Tissue expander Artificial limb Hearing aid

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Breast cancer related lymphedema<br>Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis. | Procedure: Diffusion magnetic resonance imaging<br>* Free water elimination diffusion MRI and diffusion kurtosis MRI techniques<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis | circumference in cm | baseline, 3 months after lymphaticovenous anastomosis | 
| change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis | volume in mL | baseline, 3 months after lymphaticovenous anastomosis | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphedema, supermicrosurgical technique, axillary procedures, pre-clinical animal model, diffusion MRI