Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lymphedema of Upper Limb | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Diffusion magnetic resonance imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Breast cancer related lymphedema
- description
- Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.
- interventionNames
- Procedure: Diffusion magnetic resonance imaging
Primary outcomes (2)
- measure
- change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis
- timeFrame
- baseline, 3 months after lymphaticovenous anastomosis
- description
- circumference in cm
- measure
- change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis
- timeFrame
- baseline, 3 months after lymphaticovenous anastomosis
- description
- volume in mL
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (24)
- BACKGROUNDFu MR. Breast cancer-related lymphedema: Symptoms, diagnosis, risk reduction, and management. World J Clin Oncol. 2014 Aug 10;5(3):241-7. doi: 10.5306/wjco.v5.i3.241. PMID 25114841
- BACKGROUNDYang JC, Wu SC, Wang YM, Luo SD, Kuo SC, Chien PC, Tsai PY, Hsieh CH, Lin WC. Effect of Lymphaticovenous Anastomosis on Muscle Edema, Limb, and Subfascial Volume in Lower Limb Lymphedema: MRI Studies. J Am Coll Surg. 2022 Aug 1;235(2):227-239. doi: 10.1097/XCS.0000000000000236. Epub 2022 Apr 18. PMID 35839398
- BACKGROUNDGarza R 3rd, Skoracki R, Hock K, Povoski SP. A comprehensive overview on the surgical management of secondary lymphedema of the upper and lower extremities related to prior oncologic therapies. BMC Cancer. 2017 Jul 5;17(1):468. doi: 10.1186/s12885-017-3444-9. PMID 28679373
- BACKGROUNDGranzow JW, Soderberg JM, Kaji AH, Dauphine C. An effective system of surgical treatment of lymphedema. Ann Surg Oncol. 2014 Apr;21(4):1189-94. doi: 10.1245/s10434-014-3515-y. Epub 2014 Feb 13. PMID 24522988
- BACKGROUNDWinters H, Tielemans HJP, Hameeteman M, Paulus VAA, Beurskens CH, Slater NJ, Ulrich DJO. The efficacy of lymphaticovenular anastomosis in breast cancer-related lymphedema. Breast Cancer Res Treat. 2017 Sep;165(2):321-327. doi: 10.1007/s10549-017-4335-0. Epub 2017 Jun 12. PMID 28608029
- BACKGROUNDExecutive Committee. The Diagnosis and Treatment of Peripheral Lymphedema: 2016 Consensus Document of the International Society of Lymphology. Lymphology. 2016 Dec;49(4):170-84. PMID 29908550
- BACKGROUNDLohrmann C, Felmerer G, Foeldi E, Bartholoma JP, Langer M. MR lymphangiography for the assessment of the lymphatic system in patients undergoing microsurgical reconstructions of lymphatic vessels. Microvasc Res. 2008 May;76(1):42-5. doi: 10.1016/j.mvr.2008.03.003. Epub 2008 Mar 20.