Evaluation of 3D Ultrasound in Brain Tumor Surgery

Not Applicable

Recruiting

• Conditions: Residual Tumor

• 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

Study Timeline

• Study Start: 2021-10-01
• Study First Submitted: 2023-04-24
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-13
• Last Update Submitted: 2023-07-13
• Study First Posted: 2023-07-24
• Last Update Posted: 2023-07-24
• Primary Completion: 2024-12-01
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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 Tübingen; 🇩🇪 Tübingen, Baden Würtemberg, Germany

University of Ulm; 🇩🇪 Ulm, Germany