1.5T Intraoperative MR Imaging in Craniopharyngiomas

Not Applicable

Completed

• Conditions: Craniopharyngioma
• Interventions: Other: Intraoperative imaging using 1.5T MRI

• Registration Number: NCT01206543
• Lead Sponsor: Hofmann, Bernd, M.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-04
• Primary Completion: 2005-09
• Study Completion: 2006-08
• Status Verified: 2010-09
• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-21
• Last Update Submitted: 2010-09-21
• Study First Posted: 2010-09-22
• Last Update Posted: 2010-09-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intraoperative imaging	Intraoperative imaging using 1.5T MRI	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Surgical complication	within 1st week following surgery	Rate of new deficits following surgery (excluding new endocrine deficits)

Trial Locations

Locations (1)

Department of Neurosurgery University of Erlangen; 🇩🇪 Erlangen, Germany