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

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ClinicalTrials.gov Identifier: NCT05956977
Recruitment Status : Recruiting
First Posted : July 24, 2023
Last Update Posted : July 24, 2023
Sponsor:
Collaborator:
Brainlab AG
Information provided by (Responsible Party):
Jan Coburger, University of Ulm

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Residual Tumor Device: resection with help of 3D ultrasound Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: retrospective matched pair control
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of 3D Ultrasound in Brain Tumor Surgery
Actual Study Start Date : October 1, 2021
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : March 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Brain Tumors

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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).

  2. neurological outcome [ Time Frame: both after surgery and at 3 months ]
    both at discharge and at 3 months follow up using NIHSS Score

  3. 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.


Other Outcome Measures:
  1. brainshift during surgery [ Time Frame: during surgery ]
    brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05956977


Contacts
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Contact: Jan Coburger, apl. Prof. Dr. med. 0822196 ext 28858 jan.coburger@uni-ulm.de
Contact: Christian R Wirtz, Prof. Dr. med. 0822196 ext 0

Locations
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Germany
University of Tübingen Recruiting
Tübingen, Baden Würtemberg, Germany
Contact: Constantin Roder, Prof. Dr. me.d         
University of Ulm Recruiting
Ulm, Germany
Contact: Jan Coburger, MD       jan.coburger@uni-ulm.de   
Sponsors and Collaborators
University of Ulm
Brainlab AG
More Information
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Publications of Results:

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Responsible Party: Jan Coburger, apl. Prof. Dr. med. Jan Coburger, Consultant, University of Ulm
ClinicalTrials.gov Identifier: NCT05956977    
Other Study ID Numbers: Neuro3DUS
First Posted: July 24, 2023    Key Record Dates
Last Update Posted: July 24, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasm, Residual
Neoplasms
Neoplastic Processes
Pathologic Processes