Technical Development of up to 7T Magnetic Field Strength
1 other identifier
interventional
69
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable healthy
Started Sep 2015
Longer than P75 for not_applicable healthy
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 18, 2015
CompletedFirst Submitted
Initial submission to the registry
January 21, 2016
CompletedFirst Posted
Study publicly available on registry
January 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 24, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
March 24, 2022
CompletedApril 1, 2022
March 1, 2022
6.5 years
January 21, 2016
March 24, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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
Study Arms (2)
Control Volunteers
ACTIVE COMPARATORMRI on up to a 7T scanner without contrast.
Clinical Patients
EXPERIMENTALMRI on up to a 7T scanner without contrast.+ 10 minutes of research development imaging added onto their clinical MRI scans.
Interventions
One-hour MRI on up to a 7T scanner without contrast + 10 minutes of research development imaging using radio frequency (RF) coils
Eligibility Criteria
You may qualify if:
- Healthy control volunteers, male and female, ages 18 and older (no history of chronic illness, concussion, malignancies, etc.)
You may not qualify if:
- Contraindications with MRI (e.g. pacemakers or ferromagnetic material near vital structures, etc.)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
New York University School of Medicine
New York, New York, 10016, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Yongxian Qian, MD
New York University Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 21, 2016
First Posted
January 28, 2016
Study Start
September 18, 2015
Primary Completion
March 24, 2022
Study Completion
March 24, 2022
Last Updated
April 1, 2022
Record last verified: 2022-03