Back to results1.5T Intraoperative MR Imaging in Craniopharyngiomas
Primary Purpose
Craniopharyngioma
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Intraoperative imaging using 1.5T MRI
Sponsored by
About this trial
This is an interventional treatment trial for Craniopharyngioma focused on measuring Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal
Eligibility Criteria
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
Sites / Locations
- Department of Neurosurgery University of Erlangen
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Intraoperative imaging
Arm Description
Outcomes
Primary Outcome Measures
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.
Rate of achievement of intended extent of removal
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Diagnostic reliability
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
Secondary Outcome Measures
Surgical complication
Rate of new deficits following surgery (excluding new endocrine deficits)
Full Information
NCT ID
NCT01206543
First Posted
September 20, 2010
Last Updated
September 21, 2010
Sponsor
Hofmann, Bernd, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01206543
Brief Title
1.5T Intraoperative MR Imaging in Craniopharyngiomas
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
April 2002 (undefined)
Primary Completion Date
September 2005 (Actual)
Study Completion Date
August 2006 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Hofmann, Bernd, M.D.
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Craniopharyngioma
Keywords
Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intraoperative imaging
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Intraoperative imaging using 1.5T MRI
Intervention Description
Intraoperative imaging and determination of degree of resection / complete tumor removal
Primary Outcome Measure Information:
Title
Rate of additional tumor removal
Description
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.
Time Frame
up to 3-4 months following surgery
Title
Rate of achievement of intended extent of removal
Description
It is examined whether the extent of tumor removal defined prior to surgery was achieved
Time Frame
up to three months following surgery
Title
Diagnostic reliability
Description
false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
Time Frame
within 3 -4 months following surgery
Secondary Outcome Measure Information:
Title
Surgical complication
Description
Rate of new deficits following surgery (excluding new endocrine deficits)
Time Frame
within 1st week following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
75 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bernd Hofmann, MD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Neurosurgery University of Erlangen
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
1.5T Intraoperative MR Imaging in Craniopharyngiomas
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