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1.5T Intraoperative MR Imaging in Craniopharyngiomas

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)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01206543
Enrollment
25
Registered
2010-09-22
Start date
2002-04-30
Completion date
2006-08-31
Last updated
2010-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Craniopharyngioma

Keywords

Craniopharyngioma, Surgery, Intraoperative imaging, Rate of total removal

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.

Interventions

OTHERIntraoperative imaging using 1.5T MRI

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

Sponsors

Hofmann, Bernd, M.D.
Lead SponsorINDIV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 75 Years

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

Design outcomes

Primary

MeasureTime frameDescription
Rate of additional tumor removalup to 3-4 months following surgeryNumber 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 removalup to three months following surgeryIt is examined whether the extent of tumor removal defined prior to surgery was achieved
Diagnostic reliabilitywithin 3 -4 months following surgeryfalse positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery

Secondary

MeasureTime frameDescription
Surgical complicationwithin 1st week following surgeryRate of new deficits following surgery (excluding new endocrine deficits)

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026