Back to resultsEvaluation of 3D Ultrasound in Brain Tumor Surgery (Neuro3DUS)
Primary Purpose
Residual Tumor
Status
Recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
resection with help of 3D ultrasound
Sponsored by
About this trial
This is an interventional treatment trial for Residual Tumor
Eligibility 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
Sites / Locations
- University of TübingenRecruiting
- University of UlmRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
prospective arm
retrospective matched pair arm
Arm Description
Use of 3D ultrasound intraoperative before intraoperative MRI
no use of intraoperative ultrasound before intraoperative MRI
Outcomes
Primary Outcome Measures
Extent of resection
Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
Secondary Outcome Measures
image quality
ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
neurological outcome
both at discharge and at 3 months follow up using NIHSS Score
Accuracy of device
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.
Full Information
NCT ID
NCT05956977
First Posted
April 24, 2023
Last Updated
July 13, 2023
Sponsor
University of Ulm
Collaborators
Brainlab AG
1. Study Identification
Unique Protocol Identification Number
NCT05956977
Brief Title
Evaluation of 3D Ultrasound in Brain Tumor Surgery
Acronym
Neuro3DUS
Official Title
Evaluation of 3D Ultrasound in Brain Tumor Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2024 (Anticipated)
Study Completion Date
March 31, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Ulm
Collaborators
Brainlab AG
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Residual Tumor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
retrospective matched pair control
Masking
Investigator
Allocation
Non-Randomized
Enrollment
90 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
prospective arm
Arm Type
Experimental
Arm Description
Use of 3D ultrasound intraoperative before intraoperative MRI
Arm Title
retrospective matched pair arm
Arm Type
No Intervention
Arm Description
no use of intraoperative ultrasound before intraoperative MRI
Intervention Type
Device
Intervention Name(s)
resection with help of 3D ultrasound
Intervention Description
see above
Primary Outcome Measure Information:
Title
Extent of resection
Description
Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.
Time Frame
48 hours after surgery
Secondary Outcome Measure Information:
Title
image quality
Description
ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
Time Frame
during surgery
Title
neurological outcome
Description
both at discharge and at 3 months follow up using NIHSS Score
Time Frame
both after surgery and at 3 months
Title
Accuracy of device
Description
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.
Time Frame
during surgery
Other Pre-specified Outcome Measures:
Title
brainshift during surgery
Description
brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI
Time Frame
during surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Coburger, apl. Prof. Dr. med.
Phone
0822196
Ext
28858
Email
jan.coburger@uni-ulm.de
First Name & Middle Initial & Last Name or Official Title & Degree
Christian R Wirtz, Prof. Dr. med.
Phone
0822196
Ext
0
Facility Information:
Facility Name
University of Tübingen
City
Tübingen
State/Province
Baden Würtemberg
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Constantin Roder, Prof. Dr. me.d
Facility Name
University of Ulm
City
Ulm
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Coburger, MD
Email
jan.coburger@uni-ulm.de
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
36135087
Citation
Aleo D, Elshaer Z, Pfnur A, Schuler PJ, Fontanella MM, Wirtz CR, Pala A, Coburger J. Evaluation of a Navigated 3D Ultrasound Integration for Brain Tumor Surgery: First Results of an Ongoing Prospective Study. Curr Oncol. 2022 Sep 15;29(9):6594-6609. doi: 10.3390/curroncol29090518.
Results Reference
result
Learn more about this trial
Evaluation of 3D Ultrasound in Brain Tumor Surgery
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