Novel MRI Techniques on Evaluation of Lymphedema

Trial Title: Novel MRI Techniques on Evaluation of Lymphedema

NCT ID: NCT05804643

Condition: Lymphedema of Upper Limb

Conditions: Official terms:
Lymphedema

Conditions: Keywords:
Lymphedema
supermicrosurgical technique
axillary procedures
pre-clinical animal model
diffusion MRI

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Cross-Sectional

Intervention:

Intervention type: Procedure
Intervention name: Diffusion magnetic resonance imaging
Description: Free water elimination diffusion MRI and diffusion kurtosis MRI techniques
Arm group label: Breast cancer related lymphedema

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.

Criteria for eligibility:

Study pop:
adults with breast cancer related lymphedema

Sampling method: Non-Probability Sample
Criteria:
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

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: National Taiwan university hospital

Address:
City: Taipei
Country: Taiwan

Status: Recruiting

Contact:
Last name: Yeefan Lee, MD

Phone: +886-2-2312-3456

Phone ext: 262570
Email: yeefanlee@ntu.edu.tw

Start date: April 10, 2023

Completion date: December 2026

Lead sponsor:
Agency: National Taiwan University Hospital
Agency class: Other

Collaborator:
Agency: National Health Research Institutes, Taiwan
Agency class: Other

Source: National Taiwan University Hospital

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05804643