7T MRI to Evaluate Cartilage Defects in the Knee

NCT ID: NCT04118023

Last Updated: 2025-02-07

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

COMPLETED

Total Enrollment

112 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-10-07

Study Completion Date

2022-09-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cartilage Injury Knee Injuries Arthropathy of Knee Cartilage Damage Knee Pain Swelling

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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7T MRI Group

Patient group that receives 7 Tesla Magnetic Resonance Imaging

7 Tesla Magnetic Resonance Imaging Test

Intervention Type DIAGNOSTIC_TEST

MAGNETOM Terra - 7T MRI Scanner by Siemens Healthineers. Each patient enrolled will undergo the study imaging test prior to planned diagnostic knee arthroscopy.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Siemens Medical Solutions

INDUSTRY

Sponsor Role collaborator

The Methodist Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Patrick McCulloch,MD

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Susan Miller, MD, MPH

Role: STUDY_CHAIR

The Methodist Hospital Research Institute

Locations

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Houston Methodist Hospital

Houston, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00022554

Identifier Type: -

Identifier Source: org_study_id

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