Any Condition With a Clinical Indication for PET/CT Exam
Conditions
Brief summary
The objective of this study is to gather image and associated data to of a pre-market PET/MRI scanner and to use the data for regulatory submission and future product development and marketing. Clinical data is required in order to test the MR attenuation correction of PET data. These aims can only be accomplished through a clinical study.
Interventions
DEVICEPET/MRI system
Compared to PET CT
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
1. Subject must have a clinical indication for a PET/CT exam 2. Subject must be at least eighteen (18) years of age 3. Female subjects that are determined to be non-pregnant by a physician investigator or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before PET/CT imaging 4. Subject must be able to hear and understand instructions without assistive devices 5. Subject must provide written informed consent 6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements 7. Subject is able to remain still for duration of imaging procedure (approximately 60 minutes total for PET/MRI); and 8. Subject must be able to participate in a PET/MR imaging session within 1 hour of concluding their PET/CT exam.
Exclusion criteria
1. Subjects who have any axial diameter larger than 55 cm 2. Subjects with a weight greater than 499 lbs 3. Subjects that have metallic/conductive or electrically/magnetically active implants without MR Safe or MR Conditional labeling, with the exception of dental devices/fillings, surgical clips, and surgical staples determined to be safe for MRI scanning by a physician investigator 4. Subjects that have implants with MR Unsafe labeling; 5. Subjects that have implants labeled as MR Conditional by the manufacturer for which the allowable conditions are not expected to be achieved by the MR/PET environment or scan protocol; 6. Subjects who have a contraindication to MRI per the screening policy of the participating site.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PET/MR Images Clinical Usefulness | 1 day | Clinically relevant images are obtained |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Single Arm PET MRI single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT | 58 |
| Total | 58 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Scan not completed due to malfunction | 3 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Single Arm PET MRI |
|---|---|
| Age, Customized Adult (>=18 years) | 58 participants |
| Sex/Gender, Customized Female | 29 participants |
| Sex/Gender, Customized Male | 29 participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 58 |
| serious Total, serious adverse events | 0 / 58 |
Outcome results
Primary
PET/MR Images Clinical Usefulness
Clinically relevant images are obtained
Time frame: 1 day
Population: Subjects with images successfully collected using PET/ MR
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single Arm PET MRI | PET/MR Images Clinical Usefulness | 51 Participants |