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Clinical Trials/NCT05956977
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.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
March 31, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University of Ulm
Responsible Party
Principal Investigator
Principal Investigator

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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