Trial Outcomes & Findings for [18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors (NCT NCT00832598)
NCT ID: NCT00832598
Last Updated: 2018-04-27
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
13 participants
Primary outcome timeframe
2 years
Results posted on
2018-04-27
Participant Flow
Participant milestones
| Measure |
PET Imaging
We will perform \[18F\]FACBC PET and \[18F\]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
|
|---|---|
|
Overall Study
STARTED
|
13
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
[18F] FACBC and [18F] FLT PET Imaging in Central Nervous System Tumors
Baseline characteristics by cohort
| Measure |
PET Imaging
n=13 Participants
We will perform \[18F\]FACBC PET and \[18F\]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
|
|---|---|
|
Age, Continuous
|
46 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 2 yearsPopulation: Data was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data was not collected
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Data was not collected
Outcome measures
Outcome data not reported
Adverse Events
PET Imaging
Serious events: 4 serious events
Other events: 0 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
PET Imaging
n=13 participants at risk
We will perform \[18F\]FACBC PET and \[18F\]FLT PET imaging on participants with gliomas scheduled for treatment with pathway inhibitor agents such as receptor tyrosine kinase inhibitors, antibodies (e.g., bevacizumab), VEGF-Trap, etc.
|
|---|---|
|
Psychiatric disorders
Confusion
|
7.7%
1/13 • 17 months
|
|
General disorders
Extremity-lower (gait/walking)
|
7.7%
1/13 • 17 months
|
|
Nervous system disorders
Memory-impairment
|
7.7%
1/13 • 17 months
|
|
Nervous system disorders
Pain - headache
|
7.7%
1/13 • 17 months
|
Other adverse events
Adverse event data not reported
Additional Information
Dr. Ronald Blasburg, MD
Memorial Sloan Kettering Cancer Center
Phone: 646-888-2211
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place