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1.5T Intraoperative MR Imaging in Craniopharyngiomas

NCT ID: NCT01206543

Last Updated: 2010-09-22

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

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-04-30

Study Completion Date

2006-08-31

Brief Summary

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Purpose of this study is to investigate whether intraoperative imaging using a 1.5T MRI in craniopharyngioma surgery is useful in order to increase the rate of complete tumor removal.

Detailed Description

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Conditions

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Craniopharyngioma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intraoperative imaging

Group Type EXPERIMENTAL

Intraoperative imaging using 1.5T MRI

Intervention Type OTHER

Intraoperative imaging and determination of degree of resection / complete tumor removal

Interventions

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Intraoperative imaging using 1.5T MRI

Intraoperative imaging and determination of degree of resection / complete tumor removal

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* complex craniopharyngioma \> 1cm extension within 2 or more cranial fossae or ventricular system
* Patient or legal representative able to provide written informed consent

Exclusion Criteria

* tumor size\< 1 cm
* Patients with any condition considered a contraindication to MRI
* Patients with any condition considered a contraindication for surgery
* Hypothalamic disturbances
* Hypothalamic edema
Minimum Eligible Age

3 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hofmann, Bernd, M.D.

INDIV

Sponsor Role lead

Responsible Party

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University of Erlangen-Nuremberg

Principal Investigators

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Bernd Hofmann, MD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Department of Neurosurgery University of Erlangen

Erlangen, , Germany

Site Status

Countries

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Germany

Other Identifiers

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Cranio 15

Identifier Type: -

Identifier Source: org_study_id