Novel MRI Techniques on Evaluation of Lymphedema

April 16, 2023 updated by: National Taiwan University Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

210

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • National Taiwan University Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

adults with breast cancer related lymphedema

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast cancer related lymphedema
Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.
Procedure: Diffusion magnetic resonance imaging
Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
Time Frame: baseline, 3 months after lymphaticovenous anastomosis
circumference in cm
baseline, 3 months after lymphaticovenous anastomosis
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis
Time Frame: baseline, 3 months after lymphaticovenous anastomosis
volume in mL
baseline, 3 months after lymphaticovenous anastomosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Taiwan University Hospital

Collaborators

National Health Research Institutes, Taiwan

Investigators

  • Principal Investigator: Li-Wei Kuo, Ph.D., National Health Research Institutes, Taiwan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2023

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2026

Study Registration Dates

First Submitted

March 8, 2023

First Submitted That Met QC Criteria

March 27, 2023

First Posted (Actual)

April 7, 2023

Study Record Updates

Last Update Posted (Actual)

April 19, 2023

Last Update Submitted That Met QC Criteria

April 16, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202301160RINA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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