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Imaging Study of Glioblastomas Treated With Avastin

This study has been terminated.
(insufficient accrual)
Sponsor:
Collaborators:
University of Western Ontario, Canada
London Regional Cancer Program, Canada
Information provided by (Responsible Party):
Barbara Fisher, London Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01549392
First received: February 17, 2012
Last updated: September 11, 2014
Last verified: September 2014
Results First Received: April 2, 2014  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Malignant Gliomas
Interventions: Device: DECT
Device: MR spectroscopy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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


Participant Flow:   Overall Study
    DECT/MRS in Patients Receiving Avastin     DECT/MRS in Glioma Patients Not Receiving Avastin  
STARTED     3     0  
COMPLETED     2     0  
NOT COMPLETED     1     0  
Withdrawal by Subject                 1                 0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
patients with recurrent glioblastoma

Reporting Groups
  Description
DECT/MRS in Patients Receiving Avastin

-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 Total of all reporting groups

Baseline Measures
    DECT/MRS in Patients Receiving Avastin     DECT/MRS in Glioma Patients Not Receiving Avastin     Total  
Number of Participants  
[units: participants]
  3     0     3  
Age  
[units: years]
Median ( Full Range )
  50  
  ( 45 to 65 )  
   
   
  50  
  ( 45 to 65 )  
Age  
[units: participants]
     
<=18 years     0         0  
Between 18 and 65 years     3         3  
>=65 years     0         0  
Gender  
[units: participants]
     
Female     2         2  
Male     1         1  
Region of Enrollment  
[units: participants]
     
Canada     3         3  



  Outcome Measures

1.  Primary:   3 Month Response   [ Time Frame: at 3 months after initial DECT and MR spectroscopy ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Barbara Fisher
Organization: London Health Sciences Hospital
phone: 519-685-8650
e-mail: barbara.fisher@lhsc.on.ca


No publications provided


Responsible Party: Barbara Fisher, London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01549392     History of Changes
Other Study ID Numbers: LRCP02
Study First Received: February 17, 2012
Results First Received: April 2, 2014
Last Updated: September 11, 2014
Health Authority: Canada: Ethics Review Committee