Novel MRI Techniques on Evaluation of Lymphedema

NCT05804643 | Recruiting

• 1 other identifier: 202301160RINA
• Study Type: observational
• Target: 210
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema of Upper Limb

Keywords

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

Outcome Measures

Primary Outcomes (2)

• change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis

  circumference in cm

  baseline, 3 months after lymphaticovenous anastomosis

• change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis

  volume in mL

  baseline, 3 months after lymphaticovenous anastomosis

Study Arms (1)

Breast cancer related lymphedema

Breast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.

Procedure: Diffusion magnetic resonance imaging

Interventions

Diffusion magnetic resonance imaging PROCEDURE

Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Breast cancer related lymphedema

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

adults with breast cancer related lymphedema

You may qualify if:

• adults with breast cancer related lymphedema

You may not qualify if:

• 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

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• National Health Research Institutes, Taiwan: collaborator

Study Sites (1)

National Taiwan university hospital

Taipei, Taiwan

RECRUITING

Related Publications (24)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

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• 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.

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• Franconeri A, Ballati F, Panzuto F, Raciti MV, Smedile A, Maggi A, Asteggiano C, Esposito M, Stoppa D, Lungarotti L, Bortolotto C, Giardini D, De Silvestri A, Calliada F. A proposal for a semiquantitative scoring system for lymphedema using Non-contrast Magnetic Resonance Lymphography (NMRL): Reproducibility among readers and correlation with clinical grading. Magn Reson Imaging. 2020 May;68:158-166. doi: 10.1016/j.mri.2020.02.004. Epub 2020 Feb 10.

  PMID: 32057940 BACKGROUND

• Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.

  PMID: 28245075 BACKGROUND

• Arrive L, Derhy S, El Mouhadi S, Monnier-Cholley L, Menu Y, Becker C. Noncontrast Magnetic Resonance Lymphography. J Reconstr Microsurg. 2016 Jan;32(1):80-6. doi: 10.1055/s-0035-1549133. Epub 2015 Mar 31.

  PMID: 25826439 BACKGROUND

• Lohrmann C, Foeldi E, Speck O, Langer M. High-resolution MR lymphangiography in patients with primary and secondary lymphedema. AJR Am J Roentgenol. 2006 Aug;187(2):556-61. doi: 10.2214/AJR.05.1750.

  PMID: 16861563 BACKGROUND

• Bae JS, Yoo RE, Choi SH, Park SO, Chang H, Suh M, Cheon GJ. Evaluation of lymphedema in upper extremities by MR lymphangiography: Comparison with lymphoscintigraphy. Magn Reson Imaging. 2018 Jun;49:63-70. doi: 10.1016/j.mri.2017.12.024. Epub 2018 Jan 3.

  PMID: 29306049 BACKGROUND

• Hagmann P, Jonasson L, Maeder P, Thiran JP, Wedeen VJ, Meuli R. Understanding diffusion MR imaging techniques: from scalar diffusion-weighted imaging to diffusion tensor imaging and beyond. Radiographics. 2006 Oct;26 Suppl 1:S205-23. doi: 10.1148/rg.26si065510.

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• Basser PJ, Mattiello J, LeBihan D. MR diffusion tensor spectroscopy and imaging. Biophys J. 1994 Jan;66(1):259-67. doi: 10.1016/S0006-3495(94)80775-1.

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• Jensen JH, Helpern JA, Ramani A, Lu H, Kaczynski K. Diffusional kurtosis imaging: the quantification of non-gaussian water diffusion by means of magnetic resonance imaging. Magn Reson Med. 2005 Jun;53(6):1432-40. doi: 10.1002/mrm.20508.

  PMID: 15906300 BACKGROUND

• Jensen JH, Helpern JA. MRI quantification of non-Gaussian water diffusion by kurtosis analysis. NMR Biomed. 2010 Aug;23(7):698-710. doi: 10.1002/nbm.1518.

  PMID: 20632416 BACKGROUND

• Chhetri A, Li X, Rispoli JV. Current and Emerging Magnetic Resonance-Based Techniques for Breast Cancer. Front Med (Lausanne). 2020 May 12;7:175. doi: 10.3389/fmed.2020.00175. eCollection 2020.

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• Tang L, Zhou XJ. Diffusion MRI of cancer: From low to high b-values. J Magn Reson Imaging. 2019 Jan;49(1):23-40. doi: 10.1002/jmri.26293. Epub 2018 Oct 12.

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• Li Z, Li X, Peng C, Dai W, Huang H, Li X, Xie C, Liang J. The Diagnostic Performance of Diffusion Kurtosis Imaging in the Characterization of Breast Tumors: A Meta-Analysis. Front Oncol. 2020 Oct 27;10:575272. doi: 10.3389/fonc.2020.575272. eCollection 2020.

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• Liu W, Wei C, Bai J, Gao X, Zhou L. Histogram analysis of diffusion kurtosis imaging in the differentiation of malignant from benign breast lesions. Eur J Radiol. 2019 Aug;117:156-163. doi: 10.1016/j.ejrad.2019.06.008. Epub 2019 Jun 17.

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• Rosenkrantz AB, Padhani AR, Chenevert TL, Koh DM, De Keyzer F, Taouli B, Le Bihan D. Body diffusion kurtosis imaging: Basic principles, applications, and considerations for clinical practice. J Magn Reson Imaging. 2015 Nov;42(5):1190-202. doi: 10.1002/jmri.24985. Epub 2015 Jun 26.

  PMID: 26119267 BACKGROUND

• Collier Q, Veraart J, Jeurissen B, Vanhevel F, Pullens P, Parizel PM, den Dekker AJ, Sijbers J. Diffusion kurtosis imaging with free water elimination: A bayesian estimation approach. Magn Reson Med. 2018 Aug;80(2):802-813. doi: 10.1002/mrm.27075. Epub 2018 Feb 2.

  PMID: 29393531 BACKGROUND

• Bergamino M, Walsh RR, Stokes AM. Free-water diffusion tensor imaging improves the accuracy and sensitivity of white matter analysis in Alzheimer's disease. Sci Rep. 2021 Mar 26;11(1):6990. doi: 10.1038/s41598-021-86505-7.

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MeSH Terms

Conditions

Lymphedema

Interventions

Diffusion Tensor Imaging

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diffusion Magnetic Resonance Imaging; Magnetic Resonance Imaging; Tomography; Diagnostic Techniques, Neurological; Investigative Techniques

Study Officials

• Li-Wei Kuo, Ph.D.

  National Health Research Institutes, Taiwan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yeefan Lee, MD

CONTACT

+886-972653172; yeefanlee@ntu.edu.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2023
• First Posted: April 7, 2023
• Study Start: April 10, 2023
• Primary Completion: December 1, 2024
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 19, 2023

Record last verified: 2023-03

Locations

TW (1)