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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Lymphedema of Upper Limb
- Sponsor
- National Taiwan University Hospital
- Enrollment
- 210
- Locations
- 1
- Primary Endpoint
- change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
Time Frame: baseline, 3 months after lymphaticovenous anastomosis
circumference in cm
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis
Time Frame: baseline, 3 months after lymphaticovenous anastomosis
volume in mL