Technical Development of up to 7T Magnetic Field Strength

NCT ID: NCT02666638

Last Updated: 2022-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-09-18
• Study Completion Date: 2022-03-24

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.

Conditions

Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Control Volunteers

MRI on up to a 7T scanner without contrast.

Group Type: ACTIVE_COMPARATOR

Control Volunteers

Intervention Type: OTHER

MRI on up to a 7T scanner without contrast.

Clinical Patients

MRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans.

Group Type: EXPERIMENTAL

Clinical Volunteers

Intervention Type: OTHER

One-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils

Interventions

Control Volunteers

MRI on up to a 7T scanner without contrast.

Intervention Type: 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

Intervention Type: OTHER

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yongxian Qian, MD

Role: PRINCIPAL_INVESTIGATOR

New York University Medical School

Locations

New York University School of Medicine

New York, New York, United States

Countries

United States

Other Identifiers

14-01932

Identifier Type: -

Identifier Source: org_study_id