NCT05956977
Recruiting
Not Applicable
Evaluation of 3D Ultrasound in Brain Tumor Surgery
University of Ulm2 sites in 1 country90 target enrollmentOctober 1, 2021
ConditionsResidual Tumor
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Residual Tumor
- Sponsor
- University of Ulm
- Enrollment
- 90
- Locations
- 2
- Primary Endpoint
- Extent of resection
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
Jan Coburger
apl. Prof. Dr. med. Jan Coburger, Consultant
University of Ulm
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
Outcomes
Primary Outcomes
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 Outcomes
- neurological outcome(both after surgery and at 3 months)
- image quality(during surgery)
- Accuracy of device(during surgery)
Study Sites (2)
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