Trial Outcomes & Findings for Development of an Integrated Positron Emission Tomography/Magnetic Resonance (PET/MR) System, Accessories and Components (NCT NCT01992354)
NCT ID: NCT01992354
Last Updated: 2019-03-19
Results Overview
One PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
4 participants
Primary outcome timeframe
One (1) day
Results posted on
2019-03-19
Participant Flow
Participant milestones
| Measure |
PET/MR System
Evaluation of Positron Emission Tomography/Magnetic Resonance (PET/MR) device for image assessment and device performance
PET MR Device: General Electric (GE) PET/MRI system
|
|---|---|
|
Overall Study
STARTED
|
4
|
|
Overall Study
COMPLETED
|
4
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Single Arm
n=4 Participants
Evaluation of PET MR device for image assessment and device performance
PET MR Device: GE PET/MRI system
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
4 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
4 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: One (1) dayOne PET/MR scan per subject should be obtained. The scan images are evaluated by a subject matter expert for adequate diagnostic quality.
Outcome measures
| Measure |
PET/MR System
n=4 Participants
Evaluation of PET MR device for image assessment and device performance
PET MR Device: GE PET/MRI system
|
|---|---|
|
PET/MR Scan Obtained
Scans supporting Aim 1
|
5 scans completed
|
|
PET/MR Scan Obtained
Scans supporting Aim 2
|
0 scans completed
|
|
PET/MR Scan Obtained
Scans supporting Aim 3
|
0 scans completed
|
SECONDARY outcome
Timeframe: One dayNumber of device complaints reported during a scan
Outcome measures
| Measure |
PET/MR System
n=4 Participants
Evaluation of PET MR device for image assessment and device performance
PET MR Device: GE PET/MRI system
|
|---|---|
|
Device Complaints
|
0 Device complatints reported
|
Adverse Events
PET/MR System
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place