Trial Outcomes & Findings for Imaging Study of Glioblastomas Treated With Avastin (NCT NCT01549392)
NCT ID: NCT01549392
Last Updated: 2014-09-15
Results Overview
participants who had reduction of tumor size from avastin at 3 months
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
3 participants
Primary outcome timeframe
at 3 months after initial DECT and MR spectroscopy
Results posted on
2014-09-15
Participant Flow
Participant milestones
| Measure |
DECT/MRS in Patients Receiving Avastin
3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks
|
DECT/MRS in Glioma Patients Not Receiving Avastin
0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
|---|---|---|
|
Overall Study
STARTED
|
3
|
0
|
|
Overall Study
COMPLETED
|
2
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
DECT/MRS in Patients Receiving Avastin
3 Glioma Patients underwent DECT and MRS pre-Avastin and 3 months later after receiving avastin 10 mg/kg iv q2weeks
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later Avastin 10 mg/kg iv q2weeks
|
DECT/MRS in Glioma Patients Not Receiving Avastin
0 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Imaging Study of Glioblastomas Treated With Avastin
Baseline characteristics by cohort
| Measure |
DECT/MRS in Patients Receiving Avastin
n=3 Participants
-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
DECT/MRS in Glioma Patients Not Receiving Avastin
15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
Total
n=3 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
50 years
n=5 Participants
|
—
|
50 years
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 participants
n=5 Participants
|
—
|
0 participants
n=5 Participants
|
|
Gender
Female
|
2 participants
n=5 Participants
|
—
|
2 participants
n=5 Participants
|
|
Gender
Male
|
1 participants
n=5 Participants
|
—
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
3 participants
n=5 Participants
|
—
|
3 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: at 3 months after initial DECT and MR spectroscopyparticipants who had reduction of tumor size from avastin at 3 months
Outcome measures
| Measure |
DECT/MRS in Patients Receiving Avastin
n=3 Participants
-15 Glioma Patients with progression will undergo DECT and MRS pre-Avastin and 3 months later
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
DECT/MRS in Glioma Patients Not Receiving Avastin
15 glioma patients not receiving Avastin for recurrence studied in the same manner as Arm 1
DECT: DECT at tumor progression and 3 months later
MR spectroscopy: MR spectroscopy at tumor progression and 3 months later
|
|---|---|---|
|
3 Month Response
|
3 participants who had tumor reduction
|
—
|
Adverse Events
DECT/MRS in Patients Receiving Avastin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
DECT/MRS in Glioma Patients Not Receiving Avastin
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