Trial Outcomes & Findings for Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma (NCT NCT00060008)
NCT ID: NCT00060008
Last Updated: 2014-04-04
Results Overview
We correlated SUVmax and change in tumor volume over the subsequent year
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
18 participants
Primary outcome timeframe
One year
Results posted on
2014-04-04
Participant Flow
Participant milestones
| Measure |
18FDG-PET Scan and MR Perfusion
Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
fludeoxyglucose F 18
gadopentetate dimeglumine
|
|---|---|
|
Overall Study
STARTED
|
18
|
|
Overall Study
COMPLETED
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Fludeoxyglucose F 18 Positron Emission Tomography and Magnetic Resonance Perfusion Imaging in Patients With Neurofibromatosis 1 and Plexiform Neurofibroma
Baseline characteristics by cohort
| Measure |
18FDG-PET Scan and MR Perfusion
n=18 Participants
Subjects will undergo MRI for quantitative (2D and 3D) evaluation of plexiform neurofibroma size, MR perfusion scan, and fludeoxyglucose (18FDG) PET scan at the time of study entry. Subjects who are treated for plexiform neurofibroma will undergo another 18FDG PET scan after one year of study entry.
fludeoxyglucose F 18
gadopentetate dimeglumine
|
|---|---|
|
Age, Customized
|
14.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: One yearWe correlated SUVmax and change in tumor volume over the subsequent year
Outcome measures
| Measure |
SUVmax < 2
n=11 Participants
Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
|
SUVmax >2
n=4 tumors
Subjects underwent MRI for quantitative (3D) evaluation of plexiform neurofibroma size and fludeoxyglucose (18FDG) PET scan at the time of study entry.
|
|---|---|---|
|
Tumor Progression as Measured by Tumor Area and Volume at 1 Year.
|
4 percentage of change
Interval -0.6 to 63.0
|
27 percentage of change
Interval 16.0 to 32.0
|
Adverse Events
18FDG-PET Scan and MR Perfusion
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