Technical Development of up to 7T Magnetic Field Strength

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Control Volunteers; Other: Clinical Volunteers

• Registration Number: NCT02666638
• Lead Sponsor: NYU Langone Health

Brief Summary

The objective of this study is to determine whether these new image acquisition strategies and techniques using of up to 7T can produce meaningful structural and physiological information that can serve to improve our understanding of various disease processes in the clinical setting. 200 Control volunteers will be scanned for approximately one hour, without contrast, on up to 7T MRI scanner. 200 Study Participants will be scanned using newly developed imaging software or hardware that conforms to applicable FDA standards and recommendations. The data (images) for the Control and Experimental Group will be de-identified by the scan technologist and downloaded to a workstation within the Radiology Department for offline processing. These images will be reviewed by a trained Radiologist after the subject has departed.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09-18
• Study First Submitted: 2016-01-21
• Study First Submitted QC: 2016-01-27
• Study First Posted: 2016-01-28
• Status Verified: 2022-03
• Primary Completion: 2022-03-24
• Study Completion: 2022-03-24
• Last Update Submitted: 2022-03-24
• Last Update Posted: 2022-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

Inclusion Criteria

• Healthy control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)

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Exclusion Criteria

• Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Volunteers	Control Volunteers	MRI on up to a 7T scanner without contrast.
Clinical Patients	Clinical Volunteers	MRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans.

Primary Outcome Measures

Name	Time	Method
Change in artifact reduction using statistical analysis	25 minutes
Change in Temporal Resolution using statistical analysis	25 minutes
Change in signal to noise ratio using statistical analysis	25 minutes
Change in image homogeneity using statistical analysis	25 minutes
Change in spatial resolution using statistical analysis	25 minutes
Change in Image Contrast using statistical analysis	25 Minutes

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States