Magic Angle Direction Imaging (MADI) ACL Study

NCT07366619 | Recruiting

• 2 other identifiers: 23CX8305IRAS 301889
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

This study will be conducted to see if a new Magnetic Resonance Imaging (MRI) scanner could give additional information or help view the body in a different way. The new scanner may be useful to diagnose conditions affecting tissues such as ligaments, tendons and cartilage more accurately, potentially improving the quality of care by the NHS. To develop such protocols and to test the clinical capabilities of the scanner, it is necessary to evaluate the scans of healthy volunteers before recruiting patient participants. Conventional MRI scans are unable to detect the signal from tissues such as ligaments, tendons, cartilage and cortical bone, which contain highly aligned collagen fibres and the signal decays too quickly to be captured. These tissues appear black and are only seen because of the surrounding brighter tissues. If a bright region appears, it can be a sign of an injury or disease, but it can also appear due to the Magic Angle artefacts, when the collagen fibres are at a specific angle to the main magnetic field of the MR scanner. This anomaly can make assessment of these tissues difficult. Currently the diagnostic gold standard is arthroscopy, though it is mostly undertaken therapeutically. The method harnesses this inherent tissue property to gain information about these collagen-rich tissues in joints. Using Magic Angle Direction Imaging (MADI) it is possible to obtain detailed information about the collagen fibre structures, and this is not available using conventional MRI. MADI could be important for planning surgery, developing new tissue implants, and monitoring outcome measures. In both standard cylindrical scanner and the conventional open scanner, it is impossible to move the magnet, nor the patient, in the required manner. This motivated the development of a novel prototype MA scanner that can move around the patient. The aim of this study is to evaluate the ability to routinely perform in-vivo Magic Angle-MRI of collagen structures in joints based on the magic angle principle, and to assess the ability to use qualitative and quantitative assessment of the Magic Angle-MR images to distinguish between the pathologies of the soft structures imaged.

Conditions

Anterior Cruciate Ligament Injuries; Meniscus Tear

Keywords

magic angle; musculoskeletal; low field; magnetic resonance imaging (MRI); knee; ACL; degenerative meniscus; patellar tendon; magic angle directional imaging (MADI); short T2; collagen fibre orientation

Outcome Measures

Primary Outcomes (1)

• Reproducibility with Magic Angle MRI

  The primary outcome measures will be the reproducibility with MA-MRI in a group of patients with known ACL tears. We will use a grading system for the radiologists to assess the MA-MRI images through a) qualitative assessment to grade ACL fibres and b) quantitative assessments to distinguish between the ACL tears with a grading system for the radiologists. 1. Visual grading of the anterior cruciate ligament fibres will be assessed (range 1-5) as follows: * 1 = not seen * 2 = probably seen * 3 = seen * 4 = readily seen * 5 = well seen 2. Visual grading of the ACL structure for patients with ligament tear will be assessed as per the table below. * 1 = no tear 0% * 2 = partial tear - low grade up to 49% * 3 = partial tear - high grade over 50% * 4 = complete tear 100%

  Before surgery and 12 months after surgery.

Secondary Outcomes (1)

• Comparison of the ACLs imaged with MA-MRI against best practice

  12 months after surgery

Study Arms (1)

Patients undergoing clinically indicated MRI for investigation for ACL injury

Patients will be recruited from ICHT orthopaedic / sports medicine clinic who have suffered an ACL injury who have also undergone clinically indicated MRI

Diagnostic Test: Magnetic Resonance Imaging

Interventions

Magnetic Resonance Imaging DIAGNOSTIC_TEST

Patients will be scanned in a prototype MRI scanner at several orientations of the MRI magnet relative to the body.

Also known as: Magic Angle Directional Imaging (MADI)

Patients undergoing clinically indicated MRI for investigation for ACL injury

Eligibility Criteria

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

Study Population

Before a patient can enter the study, they will have undergone a clinically indicated MRI for knee pathology which diagnosed an ACL injury requiring surgery.

You may qualify if:

• adults aged 18 - 65 years
• selected for ligament repair surgery
• ability to give informed consent, either written or e-consent
• no contraindications to MRI
• BMI ≤ 28 or thigh circumference less than 47 cm at approximately 7.5cm above the joint line

You may not qualify if:

• acutely unwell or frail patients in whom extension of scanning time may not be tolerated or may delay treatment
• contraindications to MRI
• participants who are too big to be able to fit in the prototype scanner
• recent surgery to the affected joint
• severe pain
• pregnant and/or breastfeeding participants

Sponsors & Collaborators

• Imperial College London: lead
• Imperial College Healthcare NHS Trust: collaborator

Study Sites (2)

Imperial College London

London, SW7 2AZ, United Kingdom

RECRUITING

Imperial College NHS Trust, Department of Surgery and Cancer

London, W6 8RF, United Kingdom

RECRUITING

Related Publications (12)

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  PMID: 25390896 BACKGROUND

• Amin NH, Hussain W, Ryan J, Morrison S, Miniaci A, Jones MH. Changes Within Clinical Practice After a Randomized Controlled Trial of Knee Arthroscopy for Osteoarthritis. Orthop J Sports Med. 2017 Apr 10;5(4):2325967117698439. doi: 10.1177/2325967117698439. eCollection 2017 Apr.

  PMID: 28451610 BACKGROUND

• Fullerton GD, Cameron IL, Ord VA. Orientation of tendons in the magnetic field and its effect on T2 relaxation times. Radiology. 1985 May;155(2):433-5. doi: 10.1148/radiology.155.2.3983395.

  PMID: 3983395 BACKGROUND

• Fullerton GD, Rahal A. Collagen structure: the molecular source of the tendon magic angle effect. J Magn Reson Imaging. 2007 Feb;25(2):345-61. doi: 10.1002/jmri.20808.

  PMID: 17260393 BACKGROUND

• Bydder M, Rahal A, Fullerton GD, Bydder GM. The magic angle effect: a source of artifact, determinant of image contrast, and technique for imaging. J Magn Reson Imaging. 2007 Feb;25(2):290-300. doi: 10.1002/jmri.20850.

  PMID: 17260400 BACKGROUND

• Du J, Pak BC, Znamirowski R, Statum S, Takahashi A, Chung CB, Bydder GM. Magic angle effect in magnetic resonance imaging of the Achilles tendon and enthesis. Magn Reson Imaging. 2009 May;27(4):557-64. doi: 10.1016/j.mri.2008.09.003. Epub 2008 Nov 20.

  PMID: 19022600 BACKGROUND

• Szeverenyi NM, Bydder GM. Dipolar anisotropy fiber imaging in a goat knee meniscus. Magn Reson Med. 2011 Feb;65(2):463-70. doi: 10.1002/mrm.22645. Epub 2010 Oct 11.

  PMID: 20939091 BACKGROUND

• Bydder GM. Review. The Agfa Mayneord lecture: MRI of short and ultrashort T(2) and T(2)* components of tissues, fluids and materials using clinical systems. Br J Radiol. 2011 Dec;84(1008):1067-82. doi: 10.1259/bjr/74368403.

  PMID: 22101579 BACKGROUND

• McGinley JV, Ristic M, Young IR. A permanent MRI magnet for magic angle imaging having its field parallel to the poles. J Magn Reson. 2016 Oct;271:60-7. doi: 10.1016/j.jmr.2016.08.001. Epub 2016 Aug 8.

  PMID: 27552556 BACKGROUND

• Jones GMC, Pitsillides AA, Meeson RL. Moving Beyond the Limits of Detection: The Past, the Present, and the Future of Diagnostic Imaging in Canine Osteoarthritis. Front Vet Sci. 2022 Mar 15;9:789898. doi: 10.3389/fvets.2022.789898. eCollection 2022.

  PMID: 35372534 BACKGROUND

• Brujic D, Chappell KE, Ristic M. Accuracy of collagen fibre estimation under noise using directional MR imaging. Comput Med Imaging Graph. 2020 Dec;86:101796. doi: 10.1016/j.compmedimag.2020.101796. Epub 2020 Oct 9.

  PMID: 33069034 BACKGROUND

• Chappell KE, Brujic D, Van Der Straeten C, Meeson R, Gedroyc W, McRobbie D, Ristic M. Detection of maturity and ligament injury using magic angle directional imaging. Magn Reson Med. 2019 Sep;82(3):1041-1054. doi: 10.1002/mrm.27794. Epub 2019 May 12.

  PMID: 31081201 BACKGROUND

MeSH Terms

Conditions

Anterior Cruciate Ligament Injuries

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

Knee Injuries; Leg Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Chinmay Gupte, PhD

  Imperial College NHS Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chinmay Gupte, PhD

CONTACT

+44 (0) 20 331 21715; chinmay.gupte@nhs.net

Karyn E Chappell, PhD

CONTACT

+44 (0) 20 7594 9212; k.chappell@imperial.ac.uk

Study Design

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

Study Record Dates

• First Submitted: January 5, 2026
• First Posted: January 26, 2026
• Study Start: January 29, 2025
• Primary Completion (Estimated): January 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: January 26, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

GB (2)