Neuro3DUS: Evaluation of 3D Ultrasound in Brain Tumor Surgery

• Sponsor: University of Ulm (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05956977
• Collaborator: Brainlab AG (Industry)
• Enrollment: 90
• Locations: 2
• Arms: 2
• Anticipated Duration (Months): 42
• Patients Per Site: 45
• Patients Per Site Per Month: 1.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Residual Tumor	Device: resection with help of 3D ultrasound	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 90 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: retrospective matched pair controlretrospective matched pair control
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of 3D Ultrasound in Brain Tumor Surgery
• Actual Study Start Date: Oct 1, 2021
• Anticipated Primary Completion Date: Dec 1, 2024
• Anticipated Study Completion Date: Mar 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prospective arm Use of 3D ultrasound intraoperative before intraoperative MRI	Device: resection with help of 3D ultrasound; see above
No Intervention: retrospective matched pair arm no use of intraoperative ultrasound before intraoperative MRI

Outcome Measures

Primary Outcome Measures

1. 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

1. image quality [during surgery]

   ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).

2. neurological outcome [both after surgery and at 3 months]

   both at discharge and at 3 months follow up using NIHSS Score

3. 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.

Other Outcome Measures

1. brainshift during surgery [during surgery]

   brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Tübingen	Tübingen	Baden Würtemberg	Germany
2	University of Ulm	Ulm		Germany

Sponsors and Collaborators

• University of Ulm
• Brainlab AG

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jan Coburger, apl. Prof. Dr. med. Jan Coburger, Consultant, University of Ulm
• ClinicalTrials.gov Identifier: NCT05956977
• Other Study ID Numbers: Neuro3DUS
• First Posted: Jul 24, 2023
• Last Update Posted: Jul 24, 2023
• Last Verified: Jul 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Neoplasm, Residual

Study Results

No Results Posted as of Jul 24, 2023