Evaluating new MRI techniques for 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
This study is testing new MRI techniques to better understand and track lymphedema in breast cancer patients to improve their treatment outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 210 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Taiwan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Taipei) |
| Trial ID | NCT05804643 on ClinicalTrials.gov |
What this trial studies
This project investigates advanced imaging methods for assessing breast cancer-related lymphedema. It includes three sub-projects: one focuses on developing a pre-clinical rat model and novel MRI techniques, another optimizes clinical MRI methods for mapping lymphedema severity, and the third evaluates post-surgical therapeutic effects. The study aims to create a comprehensive imaging database for future reference and improve the understanding of lymphedema treatment outcomes through longitudinal monitoring.
Who should consider this trial
Good fit: Ideal candidates are adults with breast cancer-related lymphedema.
Not a fit: Patients under 20 years old, pregnant individuals, or those with contraindications for MRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic and monitoring tools for patients with lymphedema, enhancing treatment outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving imaging techniques for lymphedema assessment.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taipei
- National Taiwan university hospital — Taipei, Taiwan (Recruiting)
Study contacts
- Principal investigator: Li-Wei Kuo, Ph.D. — National Health Research Institutes, Taiwan
- Study coordinator: Yeefan Lee, MD
- Email: yeefanlee@ntu.edu.tw
- Phone: +886-972653172
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.