7T MRI to Evaluate Cartilage Defects in the Knee

February 5, 2025 updated by: Patrick McCulloch,MD, The Methodist Hospital Research Institute

Improving Non-Invasive Diagnosis and Grading of Cartilage Defects in the Knee - Accuracy of Ultra High Field 7-Tesla MRI as Compared With Arthroscopy

The investigators propose to prospectively evaluate the accuracy of a novel 7-Tesla (7T) knee MRI protocol for the detection and grading of cartilage lesions in the knee, which is a significant limitation of current MRI techniques.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators hypothesize that 7T MRI will be ~ 80% sensitive for detection of cartilaginous lesions. This will be tested in a prospective multi-reader study of 100 patients who are scheduled to have knee arthroscopy. Patients will have two MRIs of the knee: one standard of care and one experimental 7T MRI. Subjects will visit at one time point prior to scheduled knee arthroscopy, for a session time of ~1-2 hours for a single 7T MRI scan.

Study Type

Observational

Enrollment (Actual)

112

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

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients of a single surgeon in an outpatient clinic.

Description

Inclusion Criteria:

  • Confirmed Knee Symptomatology
  • Scheduled Arthroscopic Treatment of Knee
  • Adult (equal or greater than 18 years of age)

Exclusion Criteria:

  • Active infections
  • Less than 18 years of age
  • Pregnant

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
7T MRI Group
Patient group that receives 7 Tesla Magnetic Resonance Imaging
Diagnostic test: 7 Tesla Magnetic Resonance Imaging Test
MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS)
Time Frame: baseline
  • Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) of the knee is a validated instrument utilized to grade structural abnormalities found in MRI.
  • Only the cartilage sub-score of the full WORMS will be scored in the study. Cartilage will be scored on a range from 0-6 for 6 different regional subdivisions for a minimum score of 0 and maximum score of 36. A lower score is considered a better outcome, with a score of 0 equating to normal thickness and signal of cartilage.
baseline

Collaborators and Investigators

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

Sponsor

The Methodist Hospital Research Institute

Collaborators

Siemens Medical Solutions

Investigators

  • Study Chair: Susan Miller, MD, MPH, The Methodist Hospital Research Institute

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)

October 7, 2019

Primary Completion (Actual)

August 19, 2021

Study Completion (Actual)

September 7, 2022

Study Registration Dates

First Submitted

October 4, 2019

First Submitted That Met QC Criteria

October 4, 2019

First Posted (Actual)

October 7, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 5, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00022554

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

Yes

product manufactured in and exported from the U.S.

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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