Recruiting

Novel MRI Techniques on Evaluation of Lymphedema

ClinicalTrials.gov IDNCT05804643

PhaseNot Applicable

Enrollment210

SponsorNational Taiwan University Hospital

Age20 Years

SexALL

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Conditions studied

Lymphedema of Upper Limb

About this study

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.

Interventions

Procedure: Diffusion magnetic resonance imaging — Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Primary outcomes

change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis (baseline, 3 months after lymphaticovenous anastomosis)
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis (baseline, 3 months after lymphaticovenous anastomosis)

Eligibility information

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 locations

National Taiwan university hospital, Taipei, Taiwan

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.