NCT02723214

Brief Summary

The purpose of the present study is to compare the characteristics, i.e. efficacy, duration, safety and hospital stay, of a frameless fiducial-less brain biopsy method with those of the standard frame-based stereotactic technique. Inclusion criteria: adult patients with cerebral lesions: 1) for whom no conclusive diagnosis could be settled in a noninvasive manner; and 2a) who also had surgically inaccessible lesions (or involving eloquent areas), or multifocal lesions, or lesions for which the probable diagnosis is a contraindication for craniotomy, or 2b) were too ill or too old for open craniotomy. Type of Intervention: standard frame-based stereotactic brain biopsy technique or frameless fiducial-less method using an optical based navigation system and a mini frame apparatus - trajectory guide.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2012

Longer than P75 for not_applicable

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

January 1, 2012

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 23, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2016

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

July 29, 2016

Status Verified

July 1, 2016

Enrollment Period

2.9 years

First QC Date

March 23, 2016

Last Update Submit

July 28, 2016

Conditions

Lesion of Brain

Outcome Measures

Primary Outcomes (2)

  • Diagnostic result

    Diagnostic yield, Histological - cytological evaluation of the biopsy specimens

    One month postoperatively

  • Complications

    Neurologic morbidity, New abnormal findings in the postoperative head CT scan

    One month postoperatively

Secondary Outcomes (2)

  • Length of hospitalization

    One month postoperatively

  • Duration of the whole procedure or steps

    Immediately postoperatively

Study Arms (2)

Frame-based stereotactic brain biopsy

ACTIVE COMPARATOR

Brain biopsy

Procedure: Brain biopsy

Frameless fiducial-less brain biopsy

ACTIVE COMPARATOR

Brain biopsy

Procedure: Brain biopsy

Interventions

Brain biopsyPROCEDURE

Brain biopsy using either the frame-based stereotactic technique, or a frameless fiducial-less brain biopsy method using an optical based navigation system and a mini frame apparatus - trajectory guide.

Frame-based stereotactic brain biopsyFrameless fiducial-less brain biopsy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Constantine Constantoyannis, MD, PhD

    Department of Neurosurgery, University Hospital of Patras, Faculty of Medicine, University of Patras

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 23, 2016

First Posted

March 30, 2016

Study Start

January 1, 2012

Primary Completion

December 1, 2014

Study Completion

April 1, 2016

Last Updated

July 29, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share