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

December 6, 2023 updated by: Dr. Ho Ki Wai, Chinese University of Hong Kong
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Department of Orthopaedics & Traumatology
        • Contact:
          • Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd
          • Phone Number: (852) 3505 2715
          • Email: kevinho@cuhk.edu.hk
        • Principal Investigator:
          • Ki Wai Ho, MBChB, MSc, MRCSEd, FRCSEd

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Healthy Volunteer and Knee Osteoarthritis Patient groups.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Healthy Volunteer
10 healthy volunteers to undergo radiographic examinations of the knee joint.
Radiation: 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.
Kellgren-Laurence grading I Osteoarthritis Knee
10 patients in Kellgren-Laurence grading I to undergo radiographic examinations of the knee joint.
Radiation: 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.
Kellgren-Laurence grading II Osteoarthritis Knee
10 patients in Kellgren-Laurence grading II to undergo radiographic examinations of the knee joint.
Radiation: 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.
Kellgren-Laurence grading III Osteoarthritis Knee
10 patients in Kellgren-Laurence grading III to undergo radiographic examinations of the knee joint.
Radiation: 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.
Kellgren-Laurence grading IV Osteoarthritis Knee
10 patients in Kellgren-Laurence grading IV to undergo radiographic examinations of the knee joint.
Radiation: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Degree of cartilage wear
Time Frame: Through study completion, an average of 1 year

All patient will have Xrays and MRI to quantitative assess the degree of cartilage wear.

The patient will be categorised based on their Kellgren-Lawrence grading.
Through study completion, an average of 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Oxford Knee Score
Time Frame: Through study completion, an average of 1 year
Clinical Questionnaire Assessment Tool. Subjective patient-reported outcome measurement (Oxford Knee Score) will be performed at the time of recruitment and prior to the MRI. Score 80-100 = Excellent, Score 70-79 = Good, Score 60-69 = Fair, Score below 60 = Poor.
Through study completion, an average of 1 year
Knee Society Function Score
Time Frame: Through study completion, an average of 1 year
Clinical Questionnaire Assessment Tool. Score from 100 to -20. The higher the score, the better the knee function outcome.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chinese University of Hong Kong

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 16, 2020

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020.115

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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