1.5T Intraoperative MR Imaging in Craniopharyngiomas

Craniopharyngioma Clinical Trial

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")

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01206543
• Other study ID #: Cranio 15
• Status: Completed
• Phase: N/A
• First received: September 20, 2010
• Last updated: September 21, 2010
• Start date: April 2002
• Est. completion date: August 2006

Study information

• Verified date: September 2010
• Source: Hofmann, Bernd, M.D.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2006
• Est. primary completion date: September 2005
• Gender: Both
• Age group: 3 Years to 75 Years

Eligibility

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

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Craniopharyngioma

Intervention

Other:
• Intraoperative imaging using 1.5T MRI
Intraoperative imaging and determination of degree of resection / complete tumor removal

Locations

Country	Name	City	State
Germany	Department of Neurosurgery University of Erlangen	Erlangen

Sponsors (1)

Lead Sponsor	Collaborator
Hofmann, Bernd, M.D.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of additional tumor removal	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	No
Primary	Rate of achievement of intended extent of removal	It is examined whether the extent of tumor removal defined prior to surgery was achieved	up to three months following surgery	No
Primary	Diagnostic reliability	false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery	within 3 -4 months following surgery	No
Secondary	Surgical complication	Rate of new deficits following surgery (excluding new endocrine deficits)	within 1st week following surgery	No