1.5T Intraoperative MR Imaging in Craniopharyngiomas

This study has been completed.
Sponsor:
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
  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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01206543

Locations
Germany
Department of Neurosurgery University of Erlangen
Erlangen, Germany, 91052
Sponsors and Collaborators
Hofmann, Bernd, M.D.
Investigators
Principal Investigator: Bernd Hofmann, MD
  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 July 22, 2014