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NCT Number: NCT05804643

Novel MRI Techniques on Evaluation of Lymphedema

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.

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Key information

Conditions

Lymphedema of Upper Limb Hemic and Lymphatic Diseases Lymphatic Diseases Lymphedema

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diffusion magnetic resonance imaging

Procedure

Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Primary outcomes

  1. change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis

    Time frame: baseline, 3 months after lymphaticovenous anastomosis

    circumference in cm

  2. change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis

    Time frame: baseline, 3 months after lymphaticovenous anastomosis

    volume in mL

Study contacts

Contact information is provided by the study sponsor or research team.

Yeefan Lee, MD

CONTACT

[email protected]

+886-972653172

Sponsors and collaborators

Lead sponsor

National Taiwan University Hospital

Other

Collaborators

  • National Health Research Institutes, Taiwan

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Apr 7, 2023
Registry last updated
Apr 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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