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Completed

NCT Number: NCT01206543

1.5T Intraoperative MR Imaging in Craniopharyngiomas

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.

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Key information

Conditions

Craniopharyngioma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Nerve Tissue Neuroectodermal Tumors

Age range

3 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Neurosurgery University of Erlangen

Erlangen, 91052, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intraoperative imaging using 1.5T MRI

Other

Intraoperative imaging and determination of degree of resection / complete tumor removal

Primary outcomes

  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 outcomes

  1. Surgical complication

    Time frame: within 1st week following surgery

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

Sponsors and collaborators

Lead sponsor

Hofmann, Bernd, M.D.

Indiv

Registry information

Official study 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")

Important dates

Study start
2002
Primary completion
2005
Study completion
2006
First posted
Sep 22, 2010
Registry last updated
Sep 22, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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