NCT05956977

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2021

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 24, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2025

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

3.2 years

First QC Date

April 24, 2023

Last Update Submit

July 13, 2023

Conditions

Residual Tumor

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • image quality

    during surgery

  • neurological outcome

    both after surgery and at 3 months

  • Accuracy of device

    during surgery

Other Outcomes (1)

  • brainshift during surgery

    during surgery

Study Arms (2)

prospective arm

EXPERIMENTAL

Use of 3D ultrasound intraoperative before intraoperative MRI

Device: resection with help of 3D ultrasound

retrospective matched pair arm

NO INTERVENTION

no use of intraoperative ultrasound before intraoperative MRI

Interventions

resection with help of 3D ultrasoundDEVICE

see above

prospective arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age above 18 suspected intra-axial lesion (metastasis or Glioma) potential gross total resection of lesion

You may not qualify if:

  • no ability for informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Tübingen

Tübingen, Baden Würtemberg, Germany

RECRUITING

University of Ulm

Ulm, Germany

RECRUITING

Related 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: 10.3390/curroncol29090518.

    PMID: 36135087RESULT

MeSH Terms

Conditions

Neoplasm, Residual

Condition Hierarchy (Ancestors)

Neoplastic ProcessesNeoplasmsPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Jan Coburger, apl. Prof. Dr. med.

CONTACT

0822196jan.coburger@uni-ulm.de

Christian R Wirtz, Prof. Dr. med.

CONTACT

0822196

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: retrospective matched pair control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
apl. Prof. Dr. med. Jan Coburger, Consultant

Study Record Dates

First Submitted

April 24, 2023

First Posted

July 24, 2023

Study Start

October 1, 2021

Primary Completion

December 1, 2024

Study Completion

March 31, 2025

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)