Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
IMAGER
2 other identifiers
interventional
108
1 country
1
Brief Summary
The investigators hypothesize that the rate of radiologically complete resections of contrast-enhancing brain tumors following surgeries aided by use of 5-ALA induced fluorescence guidance and use of an intraoperative ultra-low field MRI is higher compared to surgeries aided by 5-ALA induced fluorescene alone.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2013
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2013
CompletedFirst Posted
Study publicly available on registry
February 26, 2013
CompletedStudy Start
First participant enrolled
March 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2016
CompletedFebruary 26, 2013
February 1, 2013
1.9 years
February 22, 2013
February 25, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Extent of Resection
The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.
Early postoperative MRI within 72 hrs
Secondary Outcomes (4)
Volumetric extent of resection
Early postoperative MRI within 72hrs
PFS 6
6 months following surgery
PFS 12
12 months following surgery
Quality of life
6 months/12 months
Other Outcomes (1)
NIHSS
5 days following surgery
Study Arms (2)
Control arm
OTHER5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Interventional arm
OTHER5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Interventions
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Eligibility Criteria
You may qualify if:
- adult patient (\> 18 years) able to give informed consent
- primary supratentorial intra-axial brain tumor exhibiting contrast enhancement suspected to be malignant glioma
- tumor must be deemed completely resectable by neurosurgeon
- diagnostic MRI
You may not qualify if:
- patient unable or unwilling to give informed consent
- infratentorial tumor location
- tumor location in or near eloquent areas
- multifocal tumor
- existance of contraindications to undergo MRI examination
- previous surgical treatment for an intraaxial brain tumor
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Klinik für Neurochirurgie Johann Wolfgang Goethe University
Frankfurt am Main, Hesse, 60528, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christian Senft, MD PhD
Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PD Dr. med. Christian Senft
Study Record Dates
First Submitted
February 22, 2013
First Posted
February 26, 2013
Study Start
March 1, 2013
Primary Completion
February 1, 2015
Study Completion
February 1, 2016
Last Updated
February 26, 2013
Record last verified: 2013-02