CClinicalTrials.gg
Sign In
RecruitingNCT05956977Neuro3DUSUpdated Jul 24, 2023

Evaluation of 3D Ultrasound in Brain Tumor Surgery

An interventional study of resection with help of 3D ultrasound in Residual Tumor, sponsored by University of Ulm. Recruiting at 2 sites in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-24.

Sponsored by University of Ulm · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2024, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Registered 1 year 6 months after the study started (first participant enrolled Oct 2021, registered Apr 2023).
  • Started Oct 2021; still recruiting 5 years later.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Residual Tumor

Browse trials for

03

In context

Neoplasm, Residual

263 studies on the registry are indexed under Neoplasm, Residual; 120 are open to participants now.

This study's planned enrollment of 90 is above the median of 46 across 167 interventional studies indexed under Neoplasm, Residual.

Browse Neoplasm, Residual studies →

Lead sponsor

University of Ulm is the lead sponsor of 141 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

Exclusion Criteria:

  • no ability for informed consent
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
90 participants (estimated)

Study arms

  • Experimental
    prospective arm

    Use of 3D ultrasound intraoperative before intraoperative MRI

    Device: resection with help of 3D ultrasound

  • No intervention
    retrospective matched pair arm

    no use of intraoperative ultrasound before intraoperative MRI

Interventions

  • Deviceresection with help of 3D ultrasound

    see above

06

What researchers measure

Primary outcomes

  1. Extent of resection

    Volumetric assessment of residual T1 contrast enhancement or FLAIR signal changes in enhancing and non-enhancing glioma, respectively.

    Time frame: 48 hours after surgery

Secondary outcomes

  1. image quality

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

    Time frame: during surgery

  2. neurological outcome

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

    Time frame: both after surgery and at 3 months

  3. 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.

    Time frame: during surgery

Other outcomes

  1. brainshift during surgery

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

    Time frame: during surgery

07

Study locations

2 of 2 sites recruiting
  • University of Tübingen
    Tübingen, Baden Würtemberg, Germany
    • Constantin Roder, Prof. Dr. me.d · Contact
    Recruiting
  • University of Ulm
    Ulm, Germany
    Recruiting
08

References and documents

Publications

  • 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. PubMed 36135087 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05956977
Lead sponsor
University of Ulm
Collaborators
Brainlab AG
Responsible party
Jan Coburger (apl. Prof. Dr. med. Jan Coburger, Consultant, University of Ulm) — Principal investigator
First posted
Jul 24, 2023
Start date
Oct 1, 2021
Primary completion
Dec 1, 2024 (estimated)
Completion
Mar 31, 2025 (estimated)
Last update
Jul 24, 2023

Study contacts

Jan Coburger, apl. Prof. Dr. med.
Contact
jan.coburger@uni-ulm.de
0822196 ext. 28858
Christian R Wirtz, Prof. Dr. med.
Contact
0822196 ext. 0

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Neoplasm, Residual→

Other studies from this sponsor

University of Ulm

Start the discussion