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Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery (IMAGER)

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ClinicalTrials.gov Identifier: NCT01798771
Recruitment Status : Unknown
Verified February 2013 by Dr. Christian Senft, Johann Wolfgang Goethe University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : February 26, 2013
Last Update Posted : February 26, 2013
Sponsor:
Information provided by (Responsible Party):
Dr. Christian Senft, Johann Wolfgang Goethe University Hospital

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.

Condition or disease Intervention/treatment Phase
Primary Malignant Neoplasm of Nervous System Glioma Glioblastoma Metastasis Procedure: Interventional arm Procedure: Control arm Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intraoperative MRI and 5-ALA Guidance to Improve the Extent of Resection in Brain Tumor Surgery
Study Start Date : March 2013
Estimated Primary Completion Date : February 2015
Estimated Study Completion Date : February 2016


Arm Intervention/treatment
Control arm
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Procedure: Control arm
5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.
Other Names:
  • 5-ALA
  • 5-Aminolevulinic acid hydrochloride

Interventional arm
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Procedure: Interventional arm
5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.
Other Names:
  • 5-ALA
  • 5-Aminolevulinic acid hydrochloride




Primary Outcome Measures :
  1. Extent of Resection [ Time Frame: Early postoperative MRI within 72 hrs ]
    The primary efficacy endpoint is the rate of complete resections according to early postoperative MRI.


Secondary Outcome Measures :
  1. Volumetric extent of resection [ Time Frame: Early postoperative MRI within 72hrs ]
    Secondary endpoint is the volumetric extent of resection as determined by direct comparison of preoperative and early postoperative tumor volumes.

  2. PFS 6 [ Time Frame: 6 months following surgery ]
    Secondary endpoint is the rate of subjects with progression-free survival (PFS) 6 months after tumor resection

  3. PFS 12 [ Time Frame: 12 months following surgery ]
    Secondary endpoint is the rate of subjects with progression-free survival (PFS) 12 months after tumor resection

  4. Quality of life [ Time Frame: 6 months/12 months ]
    Patient quality of life at 6 and 12 months following surgery is a secondary endpoint


Other Outcome Measures:
  1. NIHSS [ Time Frame: 5 days following surgery ]
    The change of NIHSS (The NIH Stroke Scale) score is an other pre-specified outcome measure



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01798771


Contacts
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Contact: Christian Senft, MD PhD 069-6301 ext 5939 c.senft@med.uni-frankfurt.de

Locations
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Germany
Klinik für Neurochirurgie Johann Wolfgang Goethe University
Frankfurt am Main, Hessen, Germany, 60528
Contact: Christian Senft, MD PhD    069-6301 ext 5939    c.senft@med.uni-frankfurt.de   
Sponsors and Collaborators
Johann Wolfgang Goethe University Hospital
Investigators
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Principal Investigator: Christian Senft, MD PhD Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital
Additional Information:
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Responsible Party: Dr. Christian Senft, PD Dr. med. Christian Senft, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT01798771    
Other Study ID Numbers: JohannWGUH_IMAGER
206/12 ( Other Identifier: Ethics Committee Johann Wolfgang Goethe University )
First Posted: February 26, 2013    Key Record Dates
Last Update Posted: February 26, 2013
Last Verified: February 2013
Keywords provided by Dr. Christian Senft, Johann Wolfgang Goethe University Hospital:
primary brain tumor
malignant glioma
intraoperative MRI
5-ALA
Additional relevant MeSH terms:
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Glioblastoma
Glioma
Brain Neoplasms
Neoplasms
Nervous System Neoplasms
Astrocytoma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Central Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Aminolevulinic Acid
Photosensitizing Agents
Dermatologic Agents