1.5T Intraoperative MR Imaging in Craniopharyngiomas

Sponsor

Hofmann, Bernd, M.D. (Other)

Overall Status

Completed

CT.gov ID

NCT01206543

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Craniopharyngioma	Other: Intraoperative imaging using 1.5T MRI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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")

Study Start Date :

Apr 1, 2002

Actual Primary Completion Date :

Sep 1, 2005

Actual Study Completion Date :

Aug 1, 2006

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: Intraoperative imaging

Other: Intraoperative imaging using 1.5T MRI

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

Outcome Measures

Primary Outcome Measures

Rate of additional tumor removal [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.
Rate of achievement of intended extent of removal [up to three months following surgery]
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Diagnostic reliability [within 3 -4 months following surgery]
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery

Secondary Outcome Measures

Surgical complication [within 1st week following surgery]
Rate of new deficits following surgery (excluding new endocrine deficits)

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 75 Years

Sexes Eligible for Study:

All

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