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Trial record 5 of 101 for:    "Craniopharyngioma"

1.5T Intraoperative MR Imaging in Craniopharyngiomas

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01206543
Recruitment Status : Completed
First Posted : September 22, 2010
Last Update Posted : September 22, 2010
Information provided by:
Hofmann, Bernd, M.D.

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.

Condition or disease Intervention/treatment Phase
Craniopharyngioma Other: Intraoperative imaging using 1.5T MRI Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (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")
Study Start Date : April 2002
Actual Primary Completion Date : September 2005
Actual Study Completion Date : August 2006

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Arm Intervention/treatment
Experimental: Intraoperative imaging Other: Intraoperative imaging using 1.5T MRI
Intraoperative imaging and determination of degree of resection / complete tumor removal

Primary Outcome Measures :
  1. 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.

  2. 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

  3. 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

Secondary Outcome Measures :
  1. Surgical complication [ Time Frame: within 1st week following surgery ]
    Rate of new deficits following surgery (excluding new endocrine deficits)

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Ages Eligible for Study:   3 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01206543

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

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Responsible Party: Department of Neurosurgery, University of Erlangen-Nuremberg Identifier: NCT01206543     History of Changes
Other Study ID Numbers: Cranio 15
First Posted: September 22, 2010    Key Record Dates
Last Update Posted: September 22, 2010
Last Verified: September 2010
Keywords provided by Hofmann, Bernd, M.D.:
Intraoperative imaging
Rate of total removal
Additional relevant MeSH terms:
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Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Bone Neoplasms
Neoplasms by Site
Bone Diseases
Musculoskeletal Diseases