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Lymphedema of Upper LimbNCT05804643

Novel MRI Techniques on Evaluation of Lymphedema

An observational study of Lymphedema of Upper Limb, run by National Taiwan University Hospital at 1 site in Taiwan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 20 years and olderHealthy volunteers can take part
Conditions the study is for
Lymphedema of Upper Limb
What is being tested?
Diffusion magnetic resonance imaging
Type of treatment
Surgery or procedure
How many people
210 participants
Where
1 siteTaiwan
Study dates
10 Apr 2023to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: adults with breast cancer related lymphedema

Who may be able to join

  • adults with breast cancer related lymphedema

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yeefan Lee, MD contact

+886-972653172

yeefanlee@ntu.edu.tw

Taiwan1 site, 1 recruiting

  • National Taiwan university hospital

    Taipei

    Yeefan Lee, MD, +886-2-2312-3456 ext. 262570, yeefanlee@ntu.edu.tw

    Recruiting

Other trials in Taiwan

About this study

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

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.

Read the detailed 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.

Being tested
Diffusion magnetic resonance imaging
Keywords
Lymphedema, supermicrosurgical technique, axillary procedures, pre-clinical animal model, diffusion MRI
Medical subject headings
Lymphedema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Diffusion magnetic resonance imagingProcedure or surgery

    Free water elimination diffusion MRI and diffusion kurtosis MRI techniques

Study groups in NCT05804643
Study groupRoleWhat they receive
Breast cancer related lymphedemaBreast cancer related lymphedema cases receive observational magnetic resonance imaging before and after lymphovenous anastomosis.
Receives: Procedure: Diffusion magnetic resonance imaging

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    circumference in cm

    Measured: baseline, 3 months after lymphaticovenous anastomosis

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

    volume in mL

    Measured: baseline, 3 months after lymphaticovenous anastomosis

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Apr 2023
  2. Study start10 Apr 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
210 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05804643
Sponsor's protocol ID
202301160RINA
Status last verified
Mar 2023
First submitted
8 Mar 2023
Last updated
19 Apr 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 22523325

  • 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.

    PubMed 32057940

  • 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.

    PubMed 28245075

  • 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.

    PubMed 25826439

  • 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.

    PubMed 16861563

  • 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.

    PubMed 29306049

  • 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.

    PubMed 17050517

  • 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.

    PubMed 8130344

Questions about this trial

What is this clinical trial studying?

An observational study of Lymphedema of Upper Limb, run by National Taiwan University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yeefan Lee, MD (+886-972653172, yeefanlee@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change from baseline circumference of both arms at 3 months after lymphaticovenous anastomosis (time frame: baseline, 3 months after lymphaticovenous anastomosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05804643, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2023.

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