Evaluation of 3D Ultrasound in Brain Tumor Surgery

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05956977

Acronym

Neuro3DUS

Enrollment

Registered

2023-07-24

Start date

2021-10-01

Completion date

2025-03-31

Last updated

2023-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Residual Tumor

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.

Interventions

DEVICEresection with help of 3D ultrasound

see above

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Intervention model description

retrospective matched pair control

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
image quality	during surgery	ultrasound image quality, both for 2D and 3D as rated by surgeon and scored from 1(best) to 6 (worst).
neurological outcome	both after surgery and at 3 months	both at discharge and at 3 months follow up using NIHSS Score
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

Measure	Time frame	Description
brainshift during surgery	during surgery	brainshift in mm during surgery comparing preoperative landmarks with intraoperative landmarks in ultrasound and intraooperative MRI

Countries

Germany

Contacts

Primary ContactJan Coburger, apl. Prof. Dr. med.

jan.coburger@uni-ulm.de0822196

Backup ContactChristian R Wirtz, Prof. Dr. med.

0822196

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026