1.5T Intraoperative MR Imaging in Craniopharyngiomas

September 21, 2010 updated by: Hofmann, Bernd, M.D.

Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomographie-Systems in Direkter Kopplung Mit Einem Neuronavigations-System")

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erlangen, Germany, 91052
        • Department of Neurosurgery University of Erlangen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intraoperative imaging
Other: Intraoperative imaging using 1.5T MRI
Intraoperative imaging and determination of degree of resection / complete tumor removal

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of additional tumor removal
Time Frame: up to 3-4 months following surgery
Number of patients in whom non suspected tumor remants were indicated by intraoperative MRI and remnants could be removed completely thereafter. Results have to be confirmed in 1st follow up imaging.
up to 3-4 months following surgery
Rate of achievement of intended extent of removal
Time Frame: up to three months following surgery
It is examined whether the extent of tumor removal defined prior to surgery was achieved
up to three months following surgery
Diagnostic reliability
Time Frame: within 3 -4 months following surgery
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
within 3 -4 months following surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical complication
Time Frame: within 1st week following surgery
Rate of new deficits following surgery (excluding new endocrine deficits)
within 1st week following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hofmann, Bernd, M.D.

Investigators

  • Principal Investigator: Bernd Hofmann, MD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2002

Primary Completion (Actual)

September 1, 2005

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

September 20, 2010

First Submitted That Met QC Criteria

September 21, 2010

First Posted (Estimate)

September 22, 2010

Study Record Updates

Last Update Posted (Estimate)

September 22, 2010

Last Update Submitted That Met QC Criteria

September 21, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cranio 15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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