Evaluation of 3D Ultrasound in Brain Tumor Surgery (Neuro3DUS)

July 13, 2023 updated by: Jan Coburger, University of Ulm
Evaluation of impact of use of 3D ultrasound in brain tumor surgery on extend of resection. Benefit for surgery, neurological outcome, accuracy and image quality are secondary outcome parameters. Control group is a retrospective matched pair cohort.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Christian R Wirtz, Prof. Dr. med.
  • Phone Number: 0822196

Study Locations

  • Germany
    • Baden Würtemberg
      • Tübingen, Baden Würtemberg, Germany
        • Recruiting
        • University of Tubingen
        • Contact:
          • Constantin Roder, Prof. Dr. me.d

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion

Exclusion Criteria:

  • no ability for informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: prospective arm
Use of 3D ultrasound intraoperative before intraoperative MRI
Device: resection with help of 3D ultrasound
see above
No Intervention: retrospective matched pair arm
no use of intraoperative ultrasound before intraoperative MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Extent of resection
Time Frame: 48 hours after surgery
Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
48 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
image quality
Time Frame: during surgery
ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
during surgery
neurological outcome
Time Frame: both after surgery and at 3 months
both at discharge and at 3 months follow up using NIHSS Score
both after surgery and at 3 months
Accuracy of device
Time Frame: during surgery
ultrasound image acuracy compared to preoperative MRI, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst), including rating of brainshift and navigation inaccuracy.
during surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
brainshift during surgery
Time Frame: during surgery
brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI
during surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Ulm

Collaborators

Brainlab AG

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

April 24, 2023

First Submitted That Met QC Criteria

July 13, 2023

First Posted (Estimated)

July 24, 2023

Study Record Updates

Last Update Posted (Estimated)

July 24, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Neuro3DUS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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