Novel MRI Techniques on Evaluation of Lymphedema

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура Diffusion magnetic resonance imaging
  Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Первичные конечные точки

• change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis [Срок оценки: baseline, 3 months after lymphaticovenous anastomosis]
• change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis [Срок оценки: baseline, 3 months after lymphaticovenous anastomosis]

Критерии участия

Критерии включения

• adults with breast cancer related lymphedema

Критерии исключения

• children younger than 20 years old
• pregnancy
• patients who have absolute contraindications regarding MRI scanning:

• The cardiac implantable electronic device (CIED) such as pacemakers, implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy (CRT) devices.
• Metallic intraocular foreign bodies.
• Implantable neurostimulation systems
• 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.
• Drug infusion pumps (insulin delivery, analgesic drugs, or chemotherapy pumps): If possible, the patient has to remove the device.
• Catheters with metallic components (Swan-Ganz catheter)
• Metallic fragments such as bullets, shotgun pellets, and metal shrapnel
• Cerebral artery aneurysm clips
• Magnetic dental implants
• Tissue expander
• Artificial limb
• Hearing aid

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Тайвань · 1 центр

• National Taiwan university hospital — Taipei

Публикации

• Fu 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
• Yang 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
• Garza 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
• Granzow 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
• Winters 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
• Executive 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
• Lohrmann 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. PMID 18456290
• Notohamiprodjo M, Weiss M, Baumeister RG, Sommer WH, Helck A, Crispin A, Reiser MF, Herrmann KA. MR lymphangiography at 3.0 T: correlation with lymphoscintigraphy. Radiology. 2012 Jul;264(1):78-87. doi: 10.1148/radiol.12110229. Epub 2012 Apr 20. PMID 22523325

Идентификаторы

NCT: NCT05804643 · 202301160RINA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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