RecruitingNCT05804643

Novel MRI Techniques on Evaluation of Lymphedema

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


Sponsor

National Taiwan University Hospital

Enrollment

210 participants

Start Date

Apr 10, 2023

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 20 Years

Inclusion Criteria1

  • adults with breast cancer related lymphedema

Exclusion Criteria15

  • 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

Interventions

PROCEDUREDiffusion magnetic resonance imaging

Free water elimination diffusion MRI and diffusion kurtosis MRI techniques


Locations(1)

National Taiwan university hospital

Taipei, Taiwan

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NCT05804643


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