Clinical Indication for a Head MRI
Conditions
Brief summary
The purpose of the study is to collect in vivo human image data to demonstrate neurological magnetic resonance imaging (MRI) of subjects using short pulse sequences.
Detailed description
This is a single-site; open-label, prospective research Study involving human subjects. There will be no comparative efficacy or safety analysis and therefore no randomization
Interventions
DEVICEpulse sequences
Collect in vivo human data to demonstrate neurological Magnetic Resonance Imaging of subjects using a pulse sequence
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject must be at least 18 years of age * Subject must be willing and able to undergo verbal and written informed consent * Subject must have a clinical indication for a head MRI with and without Gadolinium-based contrast agent administration
Exclusion criteria
* Subjects who have any of the conditions below at the time of the enrollment or scan session are excluded from this study. Further, should it be determined by study staff that an enrolled subject meets any of the conditions below during the course of the study, the subject will be removed from the study. * Any contraindication to an MRI scan per the policy of Spectrum Health * Any contraindication to administration of an MRI contrast agent per the policy of Spectrum Health * Off-label utilization of contrast agents administered for the subject's clinical exam
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Head Images Successfully Collected | 6-months | Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence. |
Countries
United States
Participant flow
Recruitment details
Subjects with orders from their doctor for an MRI were screened from Spectrum Health's Neurology Department. The study coordinator contacts each subject that met the inclusion criteria. If the subject is interested to volunteer, a copy of the Informed Consent was sent and appointment scheduled. Seg. 1 enrolled 11 subjects; no Seg. 2 enrollment.
Pre-assignment details
This is a single arm study.
Participants by arm
| Arm | Count |
|---|---|
| Single Arm Magnetic Resonance Image Collection Using Innovative Pulse Sequences | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Scan was not completed | 1 |
Baseline characteristics
| Characteristic | Single Arm |
|---|---|
| Age, Customized <=18 years | 0 participants with images collected |
| Age, Customized >=65 years | 0 participants with images collected |
| Age, Customized Between 18 and 65 years | 10 participants with images collected |
| Region of Enrollment United States | 10 particpants with images collected |
| Sex/Gender, Customized | NA participants with images collected |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 11 |
| serious Total, serious adverse events | 0 / 11 |
Outcome results
Primary
Number of Head Images Successfully Collected
Collect head human images and associated technical and clinical information to demonstrate neurological magnetic resonance imaging of subjects using short pulse sequence.
Time frame: 6-months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm | Number of Head Images Successfully Collected | 10 Images |