Novel MRI Techniques on Evaluation of Lymphedema

Recruiting

• Conditions: Lymphedema of Upper Limb
• Interventions: Procedure: Diffusion magnetic resonance imaging

• Registration Number: NCT05804643
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Status Verified: 2023-03
• Study First Submitted: 2023-03-08
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-04-07
• Study Start: 2023-04-10
• Last Update Submitted: 2023-04-16
• Last Update Posted: 2023-04-19
• Primary Completion: 2024-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 210

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:

  1. The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.
  2. Metallic intraocular foreign bodies.
  3. Implantable neurostimulation systems
  4. 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.
  5. Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the patient has to remove the device.
  6. Catheters with metallic components (Swan-Ganz catheter)
  7. Metallic fragments such as bullets, shotgun pellets, and metal shrapnel
  8. Cerebral artery aneurysm clips
  9. Magnetic dental implants
  10. Tissue expander
  11. Artificial limb
  12. Hearing aid

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Breast cancer related lymphedema	Diffusion magnetic resonance imaging	Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.

Primary Outcome Measures

Name	Time	Method
change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis	baseline, 3 months after lymphaticovenous anastomosis	circumference in cm
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis	baseline, 3 months after lymphaticovenous anastomosis	volume in mL

Trial Locations

Locations (1)

National Taiwan university hospital; 🇨🇳 Taipei, Taiwan