Status:
COMPLETED
MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants
Lead Sponsor:
SpinTech, Inc.
Collaborating Sponsors:
Summit Medical Center
Center for Diagnostic Imaging
Conditions:
MRI
Eligibility:
All Genders
6-80 years
Phase:
NA
Brief Summary
The study's purpose is to validate STAGE images and, when applicable, their equivalence to conventional MRI through an assessment by a trained certified neuroradiologist in a clinical setting. For STA...
Detailed Description
The scope of the study includes the acquisition of MR images from a specified MR manufacturer, the installation of the STAGE device at the clinical site, the subsequent processing of the acquired MR i...
Eligibility Criteria
Inclusion
- Subjects 6-80 years of age, inclusive.
- Literate in English
- No contraindications to MR
- Not claustrophobic
Exclusion
- Subject has diffuse white matter disease or leukoaraiosis.
- Participant, or if participant is under 18 years of age, participant's parent or guardian unable to read and sign an informed consent.
- Women who are pregnant or breast-feeding.
- Those with major surgery within the past eight weeks or scheduled surgery within 30 days.
- Chronic back pain or inability to lie still for 5 minutes or more.
- History of drug or alcohol abuse.
- Individuals who exceed 28 BMI or 320 lbs.
- Individual whose girth exceeds the magnetic bore.
- Direct employee or student of the PI.
- Participants belong to a vulnerable group.
Key Trial Info
Start Date :
June 30 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 7 2021
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT04292301
Start Date
June 30 2020
End Date
January 7 2021
Last Update
June 28 2022
Active Locations (5)
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1
Loma Linda University Health
Loma Linda, California, United States, 92354
2
Insight Imaging - Center for Diagnostic Imaging
Los Gatos, California, United States, 95032
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Summit Medical Center
Edmond, Oklahoma, United States, 73013