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Development of Spin-lock and FSE Acquisitions Based 3D Quantitative Biochemical Imaging for Osteoarthritis

NCT ID: NCT04431752

Last Updated: 2023-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-03-22

Study Completion Date

2024-12-31

Brief Summary

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In Hong Kong, joint diseases are common health problems as identified by the Elderly Health Service under the Department of Health. It accounts for most of the disability of the elderly in Hong Kong. In particular, osteoarthritis (OA) is on the rise and the prevalence of OA increases with age. Women are more likely to have OA in knee and hip joints after menopause. A study in 2000 reported that among Hong Kong people aged 50 and above, 7 percent of men and 13 percent of women suffered from OA. With an ageing population, it is expected that OA will become a major public health problem in Hong Kong and worldwide and the socio-economic cost of supportive care to these patients can become a major burden to Hong Kong society and many regions in the world. Early diagnosis and prevention of OA and effective technology for treatment monitoring are very important. At present, the management of OA is not optimal and standard quality indicators suggest that the majority of persons with the disease do not receive appropriate care. Over half of the population affected with OA are unaware of the diagnosis. The research team have developed a quantitative and fully automated non-contrast MRI application for early detection and monitoring of joint diseases. The whole project was funded by the Innovation and Technology Fund (ITF) (MRP/001/18X ) started in January 2019. This clinical trial is part of the quantitative assessment of this developed technology. The team anticipate this innovation will address both OA diagnosis, surveillance and management. This can potentially increase diagnostic capabilities with minimum efforts, improving patient awareness, and improved treatment monitoring of the disease state after the interventions. Thus, the proposed technology is expected to provide betterment in the quality of life for the elderly population.

Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Healthy Volunteer

10 healthy volunteers to undergo radiographic examinations of the knee joint.

Magnetic Resonance Imaging Scan

Intervention Type RADIATION

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Kellgren-Laurence grading I Osteoarthritis Knee

10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint.

Magnetic Resonance Imaging Scan

Intervention Type RADIATION

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Kellgren-Laurence grading II Osteoarthritis Knee

10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint.

Magnetic Resonance Imaging Scan

Intervention Type RADIATION

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Kellgren-Laurence grading III Osteoarthritis Knee

10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint.

Magnetic Resonance Imaging Scan

Intervention Type RADIATION

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Kellgren-Laurence grading IV Osteoarthritis Knee

10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint.

Magnetic Resonance Imaging Scan

Intervention Type RADIATION

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Interventions

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Magnetic Resonance Imaging Scan

The selection of patients with different level of OA will be made using the existing Kellgren-Laurence grading systems. The recruited patients will receive MRI exams with our enhanced sequencing. The OA level of each patient will be determined objectively through our quantitative OA grading system on MRI, which will be compared to Kellgren-Laurence grading results to evaluate the clinical performance of the MRI.

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

* All Patients over the age of 18
* All patients must provide their written consent

In the OA group

* Patients must be affected by primary osteoarthritis of the knee (according to ACR - American College of Rheumatology - classification)
* All patients must have pain symptoms for more than or equal to 2 months
* Radiological evidence of osteoarthritis

Exclusion Criteria

* Contraindication to MRI
* Patient with a mental disability
* Claustrophobia
* Inflammatory arthritis
* Ongoing Pregnancy and breast-feeding
* Presence of severe diseases like terminal cancers
* Presence of metalwork in the knee
* Significant hematological diseases;
* Non-consenting patients who have not provided the written Informed Consent
* Gross lower limb deformity
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Chinese University of Hong Kong

OTHER

Sponsor Role lead

Responsible Party

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Dr. Ho Ki Wai

Clinical Professional Consultant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Orthopaedics & Traumatology

Hong Kong, , Hong Kong

Site Status RECRUITING

Countries

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Hong Kong

Facility Contacts

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Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd

Role: primary

Other Identifiers

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2020.115

Identifier Type: -

Identifier Source: org_study_id