Evaluation of 3D Ultrasound in Brain Tumor Surgery

Residual Tumor Clinical Trial

— Neuro3DUS  

Official title:

Evaluation of 3D Ultrasound in Brain Tumor Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05956977
• Other study ID #: Neuro3DUS
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: July 2023
• Source: University of Ulm
• Contact: Jan Coburger, apl. Prof. Dr. med.
• Phone: 0822196
• Email: jan.coburger[@]uni-ulm.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasm, Residual
• Residual Tumor

Intervention

Device:
• resection with help of 3D ultrasound
see above

Locations

Country	Name	City	State
Germany	University of Tübingen	Tübingen	Baden Würtemberg
Germany	University of Ulm	Ulm

Sponsors (2)

Lead Sponsor	Collaborator
University of Ulm	Brainlab AG

Country where clinical trial is conducted

Germany, 

References & Publications (1)

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: — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	brainshift during surgery	brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI	during surgery
Primary	Extent of resection	Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.	48 hours after surgery
Secondary	image quality	ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).	during surgery
Secondary	neurological outcome	both at discharge and at 3 months follow up using NIHSS Score	both after surgery and at 3 months
Secondary	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.	during surgery