N/A
Completed N=92
MRI Assessing Clinical Usability of STrategically Acquired Gradient Echo on Human Participants
MRI
Source: ClinicalTrials.gov NCT04292301 ↗
Enrolled (actual)
92
Serious AEs
0.0%
Results posted
Jun 2022
Primary outcomePrimary: Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs — 49; 40; 0; 0 Participants
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 STAGE images without conventional equivalent, the neuroradiologist will determine if their contrasts, intensities, and quality are sufficient and meet expectations for images used in radiological reads of the brain. The study is a multi-center study in which STAGE can be assessed at sites with different MRI manufacturers and field strengths. Site names will be made available to the collaborators and participants. The sponsor is based out of Michigan, while participating sites may be located in other states. Any funding for the study will come from an industry source, SpinTech, Inc.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Numeric Rating Scale of Clinical Usability Assessment of STAGE Outputs |
49; 40; 0; 0; 44; 45 | — |
| PRIMARY Review of STAGE Outputs for Artifact and Image Contrast |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Review of STAGE Outputs for Expected Brain Structural Appearance |
89; 0; 89; 0; 89; 0 | — |
| PRIMARY Evaluation of STAGE Image Processing Times |
17.4; 7.6; 10.1; 11.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects 6-80 years of age, inclusive.
- Literate in English
- No contraindications to MR
- Not claustrophobic
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04292301). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.