Trial Outcomes & Findings for Comparison of 18F FDG PET/CT TO PET MRI (NCT NCT01986985)
NCT ID: NCT01986985
Last Updated: 2016-03-07
Results Overview
Clinically relevant images are obtained
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
58 participants
Primary outcome timeframe
1 day
Results posted on
2016-03-07
Participant Flow
Participant milestones
| Measure |
Single Arm PET MRI
single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT
|
|---|---|
|
Overall Study
STARTED
|
58
|
|
Overall Study
COMPLETED
|
51
|
|
Overall Study
NOT COMPLETED
|
7
|
Reasons for withdrawal
| Measure |
Single Arm PET MRI
single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Scan not completed due to malfunction
|
3
|
Baseline Characteristics
Comparison of 18F FDG PET/CT TO PET MRI
Baseline characteristics by cohort
| Measure |
Single Arm PET MRI
n=58 Participants
single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT
|
|---|---|
|
Age, Customized
Adult (>=18 years)
|
58 participants
n=5 Participants
|
|
Sex/Gender, Customized
Male
|
29 participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
29 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 dayPopulation: Subjects with images successfully collected using PET/ MR
Clinically relevant images are obtained
Outcome measures
| Measure |
Single Arm PET MRI
n=58 Participants
single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT
|
|---|---|
|
PET/MR Images Clinical Usefulness
|
51 Participants
|
Adverse Events
Single Arm PET MRI
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Single Arm PET MRI
n=58 participants at risk
single group evaluation of PET/ MR for diagnostic quality of image
PET/MRI system: Compared to PET CT
|
|---|---|
|
Skin and subcutaneous tissue disorders
Localized Warming
|
6.9%
4/58 • Number of events 4
|
|
Skin and subcutaneous tissue disorders
Unilateral superficial skin injury of ear from head coil placement
|
1.7%
1/58 • Number of events 1
|
Additional Information
Terri Hanlon, Clinical Affairs Project Manager
GE Healthcare
Phone: 609-578-0173
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60