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

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

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

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 spectroscopy

participants who had reduction of tumor size from avastin at 3 months

Outcome measures

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

Barbara Fisher

London Health Sciences Hospital

Phone: 519-685-8650

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place