Technical Development of up to 7T Magnetic Field Strength

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Control Volunteers; Other: Clinical Volunteers

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Volunteers; MRI on up to a 7T scanner without contrast.	Other: Control Volunteers; MRI on up to a 7T scanner without contrast.
Experimental: Clinical Patients; MRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans.	Other: Clinical Volunteers; One-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Yongxian Qian, MD, New York University Medical School

Study record dates

Study Major Dates

• Study Start (Actual): September 18, 2015
• Primary Completion (Actual): March 24, 2022
• Study Completion (Actual): March 24, 2022

Study Registration Dates

• First Submitted: January 21, 2016
• First Submitted That Met QC Criteria: January 27, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Actual): April 1, 2022
• Last Update Submitted That Met QC Criteria: March 24, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Magnetic Resonance Imaging (MRI)
• Other Study ID Numbers: 14-01932

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No