Evaluation of 3D Ultrasound in Brain Tumor Surgery
- Conditions
- Residual Tumor
- Interventions
- Device: resection with help of 3D ultrasound
- Registration Number
- NCT05956977
- Lead Sponsor
- University of Ulm
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 90
- age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion
- no ability for informed consent
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description prospective arm resection with help of 3D ultrasound Use of 3D ultrasound intraoperative before intraoperative MRI
- Primary Outcome Measures
Name Time Method Extent of resection 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
Name Time Method image quality during surgery ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
Accuracy of device 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.
neurological outcome both after surgery and at 3 months both at discharge and at 3 months follow up using NIHSS Score
Trial Locations
- Locations (2)
University of Ulm
🇩🇪Ulm, Germany
University of Tübingen
🇩🇪Tübingen, Baden Würtemberg, Germany