NCT01206543

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2002

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2002

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2005

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 22, 2010

Completed
Last Updated

September 22, 2010

Status Verified

September 1, 2010

Enrollment Period

3.4 years

First QC Date

September 20, 2010

Last Update Submit

September 21, 2010

Conditions

Craniopharyngioma

Keywords

CraniopharyngiomaSurgeryIntraoperative imagingRate of total removal

Outcome Measures

Primary Outcomes (3)

  • Rate of additional tumor removal

    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.

    up to 3-4 months following surgery

  • Rate of achievement of intended extent of removal

    It is examined whether the extent of tumor removal defined prior to surgery was achieved

    up to three months following surgery

  • Diagnostic reliability

    false positive or negative interpretation of intraoperative imaging determined after follow-up imaging 3 - 4 months following surgery

    within 3 -4 months following surgery

Secondary Outcomes (1)

  • Surgical complication

    within 1st week following surgery

Study Arms (1)

Intraoperative imaging

EXPERIMENTAL
Other: Intraoperative imaging using 1.5T MRI

Interventions

Intraoperative imaging using 1.5T MRIOTHER

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

Intraoperative imaging

Eligibility Criteria

Age3 Years - 75 Years
Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • complex craniopharyngioma \> 1cm extension within 2 or more cranial fossae or ventricular system
  • Patient or legal representative able to provide written informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery University of Erlangen

Erlangen, 91052, Germany

Location

MeSH Terms

Conditions

Craniopharyngioma

Condition Hierarchy (Ancestors)

Neuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve Tissue

Study Officials

  • Bernd Hofmann, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDIV

Study Record Dates

First Submitted

September 20, 2010

First Posted

September 22, 2010

Study Start

April 1, 2002

Primary Completion

September 1, 2005

Study Completion

August 1, 2006

Last Updated

September 22, 2010

Record last verified: 2010-09

Locations

DE(1)