7T MRI to Evaluate Cartilage Defects in the Knee

Sponsor

The Methodist Hospital Research Institute (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04118023

Collaborator

Siemens Medical Solutions (Industry)

100

Enrollment

Location

Anticipated Duration (Months)

3.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cartilage Injury Knee Injuries Arthropathy of Knee Cartilage Damage Knee Pain Swelling	Diagnostic Test: 7 Tesla Magnetic Resonance Imaging Test

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 Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Oct 7, 2019

Anticipated Primary Completion Date :

Jan 7, 2022

Anticipated Study Completion Date :

Jan 7, 2022

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Modified Whole-Organ Magnetic Resonance Imaging Score (WORMS) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Houston Methodist Hospital	Houston	Texas	United States	77030

Sponsors and Collaborators

The Methodist Hospital Research Institute
Siemens Medical Solutions

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nakul Gupta, MD, Principal Investigator, The Methodist Hospital Research Institute

ClinicalTrials.gov Identifier:

NCT04118023

Other Study ID Numbers:

Pro00022554

First Posted:

Oct 7, 2019

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Product Manufactured in and Exported from the U.S.:

Keywords provided by Nakul Gupta, MD, Principal Investigator, The Methodist Hospital Research Institute

7T Magnetic Resonance Imaging

Clinical

Cartilaginous Lesion

Additional relevant MeSH terms:

Wounds and Injuries

Knee Injuries

Study Results

No Results Posted as of Nov 17, 2021