Subjects With Clinical Indication for PET/CT
Conditions
Brief summary
The investigational PET/MRI scanner, including attenuation correction method, is capable of producing diagnostic quality images and appropriate device functionality per user feedback.
Interventions
DEVICEPET/MRI system
Enrolled subject undergoes PET/MR scan
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
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; and 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; and 4. Subject must be able to hear and understand instructions without assistive devices; and 5. Subject must provide written informed consent; and 6. Subject has the necessary mental capacity to understand instructions, and is able to comply with protocol requirements; and 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 2 hours of concluding their PET/CT exam and within 4 hours of PET radiotracer administration.
Exclusion criteria
1. Subjects who have any axial diameter larger than 55 cm; or 2. Subjects with a weight greater than 227 kgs; or 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; or 4. Subjects that have implants with MR Unsafe labeling; or 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 ; or 6. Subjects who have a contraindication to MRI according to the screening policy of the participating site
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number Usable PET/MRI Image Sets | 1 day | The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale |
| Number of Diagnostic Quality Images | 1 day | Number of images sets deemed diagnostic quality by the investigator |
Countries
Switzerland
Participant flow
Recruitment details
First participant enrolled on January 20, 2014. Last participant enrolled on July 07, 2014 at the Zurich University Hospital site. Subject or participant recruitment was prematurely terminated because the sponsor had determined that sufficient data was collected for regulatory submissions
Pre-assignment details
Subjects/participants were enrolled in one of three study segments and received a clinically indicated PET/CT exam with radiopharmaceutical injection followed by PET/MRI scanning. Up to two subject datasets (each dataset labelled with unique subject ID) can be collected from one enrolled participant/subject.
Participants by arm
| Arm | Count |
|---|---|
| Single-Arm PET/MRI Single-group evaluation of PET/MRI for diagnostic quality of image
PET/MRI system: Enrolled subject undergoes PET/MR scan | 62 |
| Total | 62 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Withdrawal by Subject | 2 |
Baseline characteristics
| Characteristic | Single-Arm PET/MRI |
|---|---|
| Age, Customized Equal to or more than 18 years of age | 62 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 62 |
| other Total, other adverse events | 2 / 62 |
| serious Total, serious adverse events | 0 / 62 |
Outcome results
Primary
Number of Diagnostic Quality Images
Number of images sets deemed diagnostic quality by the investigator
Time frame: 1 day
Population: PET/MR Scans with qualitative comments
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm PET/MRI | Number of Diagnostic Quality Images | 67 Image sets |
Primary
Number Usable PET/MRI Image Sets
The number PET/MRI image sets determined usable by a radiologist on a yes/no binary scale
Time frame: 1 day
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Single-Arm PET/MRI | Number Usable PET/MRI Image Sets | 70 Usable image sets |