1.5T Intraoperative MR Imaging in Craniopharyngiomas
This study has been completed.
Sponsor:
Hofmann, Bernd, M.D.
Information provided by:
Hofmann, Bernd, M.D.
ClinicalTrials.gov Identifier:
NCT01206543
First received: September 20, 2010
Last updated: September 21, 2010
Last verified: September 2010
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Purpose
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 | Intervention |
|---|---|
|
Craniopharyngioma |
Other: Intraoperative imaging using 1.5T MRI |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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") |
Resource links provided by NLM:
Further study details as provided by Hofmann, Bernd, M.D.:
Primary Outcome Measures:
- Rate of additional tumor removal [ Time Frame: up to 3-4 months following surgery ] [ Designated as safety issue: No ]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 [ Time Frame: up to three months following surgery ] [ Designated as safety issue: No ]It is examined whether the extent of tumor removal defined prior to surgery was achieved
- Diagnostic reliability [ Time Frame: within 3 -4 months following surgery ] [ Designated as safety issue: No ]false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery
Secondary Outcome Measures:
- Surgical complication [ Time Frame: within 1st week following surgery ] [ Designated as safety issue: No ]Rate of new deficits following surgery (excluding new endocrine deficits)
| Enrollment: | 25 |
| Study Start Date: | April 2002 |
| Study Completion Date: | August 2006 |
| Primary Completion Date: | September 2005 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Intraoperative imaging |
Other: Intraoperative imaging using 1.5T MRI
Intraoperative imaging and determination of degree of resection / complete tumor removal
|
Eligibility| Ages Eligible for Study: | 3 Years to 75 Years |
| Genders Eligible for Study: | Both |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | Department of Neurosurgery, University of Erlangen-Nuremberg |
| ClinicalTrials.gov Identifier: | NCT01206543 History of Changes |
| Other Study ID Numbers: | Cranio 15 |
| Study First Received: | September 20, 2010 |
| Last Updated: | September 21, 2010 |
| Health Authority: | Germany: Ethics Commission |
Keywords provided by Hofmann, Bernd, M.D.:
|
Craniopharyngioma Surgery Intraoperative imaging Rate of total removal |
Additional relevant MeSH terms:
|
Craniopharyngioma Adamantinoma Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms |
Neoplasms, Nerve Tissue Bone Neoplasms Neoplasms by Site Bone Diseases Musculoskeletal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013