Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Comparative Study of Intraoperative MRI-guided vs. Conventional Glioma Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian Senft, Goethe University
ClinicalTrials.gov Identifier:
NCT01394692
First received: July 13, 2011
Last updated: October 29, 2012
Last verified: October 2012
Results First Received: September 20, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Glioma
Interventions: Procedure: intraoperative MRI-guided tumor resection
Procedure: standard microsurgery

  Participant Flow
  Hide Participant Flow

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
Intraoperative MRI tumor resection with intraoperative MRI-guidance
Conventional Group standard microsurgical tumor resection

Participant Flow:   Overall Study
    Intraoperative MRI     Conventional Group  
STARTED     29     29  
COMPLETED     29     29  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

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.
No text entered.

Reporting Groups
  Description
Intraoperative MRI tumor resection with intraoperative MRI-guidance
Conventional Group standard microsurgical tumor resection
Total Total of all reporting groups

Baseline Measures
    Intraoperative MRI     Conventional Group     Total  
Number of Participants  
[units: participants]
  29     29     58  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     20     19     39  
>=65 years     9     10     19  
Age  
[units: years]
Mean ± Standard Deviation
  57  ± 13     58  ± 13     58  ± 13  
Gender  
[units: participants]
     
Female     10     13     23  
Male     19     16     35  
Region of Enrollment  
[units: participants]
     
Germany     29     29     58  



  Outcome Measures

1.  Primary:   Extent of Resection   [ Time Frame: 72 hours ]

2.  Secondary:   Progression-free Survival   [ Time Frame: 6 months ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

3.  Secondary:   Volumetric Assessment   [ Time Frame: 72 hours ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

4.  Secondary:   Neurological Deficit   [ Time Frame: 7 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   Yes


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

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
  Hide More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Christian Senft
Organization: Johann Wolfgang Goethe University
phone: +49 69 63015939
e-mail: c.senft@med.uni-frankfurt.de


Publications of Results:

Responsible Party: Christian Senft, Goethe University
ClinicalTrials.gov Identifier: NCT01394692     History of Changes
Other Study ID Numbers: JWG-EK 239/07
Study First Received: July 13, 2011
Results First Received: September 20, 2012
Last Updated: October 29, 2012
Health Authority: Germany: Ethics Commission