Clinical Trial: 1.5T Intraoperative MR Imaging in Craniopharyngiomas

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Intraoperative Use of a MR Tomography System Combined With Neuronavigation - Analysis of the Craniopharyngioma Subgroup ("Intraoperative Nutzung Eines Kernspintomogra

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 Summary:
Sponsor: Hofmann, Bernd, M.D.

Current Primary Outcome:

  • Rate of additional tumor removal [ Time Frame: 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 [ Time Frame: up to three months following surgery ]
    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 ]
    false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery


Original Primary Outcome: Same as current

Current Secondary Outcome: Surgical complication [ Time Frame: within 1st week following surgery ]

Rate of new deficits following surgery (excluding new endocrine deficits)


Original Secondary Outcome: Same as current

Information By: Hofmann, Bernd, M.D.

Dates:
Date Received: September 20, 2010
Date Started: April 2002
Date Completion:
Last Updated: September 21, 2010
Last Verified: September 2010