Novel MRI Techniques on Evaluation of Lymphedema

Lymphedema of Upper Limb Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05804643
• Other study ID #: 202301160RINA
• Status: Recruiting
• Start date: April 10, 2023
• Est. completion date: December 2026

Study information

• Verified date: March 2023
• Source: National Taiwan University Hospital
• Contact: Yeefan Lee, MD
• Phone: +886-972653172
• Email: yeefanlee[@]ntu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 210
• Est. completion date: December 2026
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphedema
• Lymphedema of Upper Limb

Intervention

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

Locations

Country	Name	City	State
Taiwan	National Taiwan university hospital	Taipei

Sponsors (2)

Lead Sponsor	Collaborator
National Taiwan University Hospital	National Health Research Institutes, Taiwan

Country where clinical trial is conducted

Taiwan, 

References & Publications (24)

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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. — View Citation

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. — View Citation

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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. — View Citation

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis	circumference in cm	baseline, 3 months after lymphaticovenous anastomosis
Primary	change from baseline volume of both arms at 3 months after lymphaticovenous anastomosis	volume in mL	baseline, 3 months after lymphaticovenous anastomosis