Technical Development of up to 7T Magnetic Field Strength

• Sponsor: NYU Langone Health (Other)
• Overall Status: Completed
• CT.gov ID: NCT02666638
• Collaborator: (none)
• Enrollment: 69
• Location: 1
• Arms: 2
• Actual Duration (Months): 78.2
• Patients Per Site Per Month: 0.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy	Other: Control Volunteers; Other: Clinical Volunteers	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 69 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Technical Development of up to 7T Magnetic Field Strength
• Actual Study Start Date: Sep 18, 2015
• Actual Primary Completion Date: Mar 24, 2022
• Actual Study Completion Date: Mar 24, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in signal to noise ratio using statistical analysis [25 minutes]

2. Change in spatial resolution using statistical analysis [25 minutes]

3. Change in Temporal Resolution using statistical analysis [25 minutes]

4. Change in Image Contrast using statistical analysis [25 Minutes]

5. Change in image homogeneity using statistical analysis [25 minutes]

6. Change in artifact reduction using statistical analysis [25 minutes]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• NYU Langone Health

Investigators

• Principal Investigator: Yongxian Qian, MD, New York University Medical School

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: NYU Langone Health
• ClinicalTrials.gov Identifier: NCT02666638
• Other Study ID Numbers: 14-01932
• First Posted: Jan 28, 2016
• Last Update Posted: Apr 1, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by NYU Langone Health: Magnetic Resonance Imaging (MRI)

Study Results

No Results Posted as of Apr 1, 2022