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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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05804643
Enrollment
210
Registered
2023-04-07
Start date
2023-04-10
Completion date
2026-12-31
Last updated
2023-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lymphedema of Upper Limb

Keywords

Lymphedema, supermicrosurgical technique, axillary procedures, pre-clinical animal model, diffusion MRI

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.

Interventions

Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Sponsors

National Health Research Institutes, Taiwan
CollaboratorOTHER
National Taiwan University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosisbaseline, 3 months after lymphaticovenous anastomosiscircumference in cm
change from baseline volume of both arms at 3 months after lymphaticovenous anastomosisbaseline, 3 months after lymphaticovenous anastomosisvolume in mL

Countries

Taiwan

Contacts

Primary ContactYeefan Lee, MD
yeefanlee@ntu.edu.tw+886-972653172

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026