Magic Angle Direction Imaging (MADI) ACL Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

adults aged 18 - 65 years

selected for ligament repair surgery

ability to give informed consent, either written or e-consent

no contraindications to MRI

Disqualifiers

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

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

  • 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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Patients undergoing clinically indicated MRI for investigation for ACL injury1 intervention

Trial outcomes

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%

Time frame
Before surgery and 12 months after surgery.

Secondary outcomes

1

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

The secondary outcome measure will be a comparison of the ACLs (Anterior Cruciate Ligament) imaged with MA-MRI against best practice: 1. cMR images (conventional MRI) performed pre-operatively to diagnose ACL injury taken from the imaging report and qualitative and quantitative assessment by 2 radiologists using the same scale as for MA-MR images (as defined for the Primary Outcome Measures); 2. Arthroscopic assessment of the ACL during repair taken from surgical notes, evaluating the potential suitability of MA-MRI as a diagnostic tool for ACL injury. Arthroscopic grading will be as follows: * Grade 1 (Mild injury to the ACL such as stretching that has led to laxity and reduction of tension in the ligament) * Grade 2 (Partially torn ACL) * Grade 3 (Fully torn ACL) * Tibial Spine Avulsion ACL injury (The ACL itself is not torn but the bony attachment of the ligament to the tibia is pulled off)

Time frame
12 months after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Imperial College London

Lead sponsor

Imperial College Healthcare NHS Trust

Collaborator