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

NCT ID: NCT01798771

Last Updated: 2013-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2016-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Primary Malignant Neoplasm of Nervous System Glioma Glioblastoma Metastasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control arm

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

Group Type OTHER

Control arm

Intervention Type PROCEDURE

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

Interventional arm

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Group Type OTHER

Interventional arm

Intervention Type PROCEDURE

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Interventions

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Interventional arm

5-ALA fluorescence guided surgery with the additional use of an intraoperative MRI for resection control in patients with contrast enhancing tumors.

Intervention Type PROCEDURE

Control arm

5-ALA fluorescence guided surgery in patients with contrast enhancing tumors.

Intervention Type PROCEDURE

Other Intervention Names

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5-ALA 5-Aminolevulinic acid hydrochloride 5-ALA 5-Aminolevulinic acid hydrochloride

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johann Wolfgang Goethe University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Dr. Christian Senft

PD Dr. med. Christian Senft

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Christian Senft, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Dept. of Neurosurgery, Johann Wolfgang Goethe University Hospital

Locations

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Klinik für Neurochirurgie Johann Wolfgang Goethe University

Frankfurt am Main, Hesse, Germany

Site Status

Countries

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Germany

Central Contacts

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Christian Senft, MD PhD

Role: CONTACT

069-6301 ext. 5939

Facility Contacts

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Christian Senft, MD PhD

Role: primary

069-6301 ext. 5939

Other Identifiers

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206/12

Identifier Type: OTHER

Identifier Source: secondary_id

JohannWGUH_IMAGER

Identifier Type: -

Identifier Source: org_study_id

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