Diagnostics of the Anterior Cruciate Ligament (ACL) Using Magic Angle Directional Imaging (MADI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reproducibility with Magic Angle MRI
研究概览
简要总结
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.
详细描述
STUDY DESIGN
- Type of Study This is a pilot study investigating the potential role of MA-MRI in visualising and assessing ACL tears in the knee using a non-CE marked medical device.
The patient study follows on from a pilot study of healthy volunteers that enabled the research team to establish the best practice and sequences for qualitative/quantitative evaluation of the knee joint.
The MRI study protocol has been developed using healthy volunteers initially and now will be tested in patients. Methods for positioning the healthy volunteers and their limbs will now be applied to a patient cohort. The scanner is based at the Mechanical Engineering department at Imperial College London, South Kensington campus. 2. Duration It will last 36 months. 3. Number and Type of Subjects As this is a novel technique there is no data available to perform a reliable power calculation. However, similar studies to examine the efficacy of the novel MRI technique image between 20 and 30 subjects. This study will therefore recruit 20 patients. 20 healthy volunteers have previously been recruited from staff and students at Imperial College London to fine tune the methods before the patient study commences. The patient group will be recruited from ICHT sports injury/orthopaedic clinic once a diagnosis of an ACL tear has been made with conventional MRI. 4. Recruitment 20 patients will be recruited from ICHT orthopaedic / sports medicine clinic who have suffered an ACL injury who have also undergone clinically indicated MRI.
Patients will be recruited from Charing Cross Hospital and St Mary's Hospitals. They will be identified by members of the clinical team, who are also members of the research team at ICHT. NHS systems, MDT meetings and clinics will all be used to identify appropriate patients as per the inclusion and exclusion criteria (participant entry). A poster with a QR code to contact the study coordinator should patients wish to take part in the study will be placed in the orthopaedic and sport clinic waiting room.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Magnetic Resonance Imaging (Diagnostic Test)
结局指标
主要结局
Reproducibility with Magic Angle MRI
时间窗: Before surgery and 12 months after surgery.
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%
次要结局
- Comparison of the ACLs imaged with MA-MRI against best practice(12 months after surgery)