Evaluation of 3D Ultrasound in Brain Tumor Surgery

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05956977
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Ulm
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Residual Tumor
Arms & Interventions

Arms

Experimental: prospective arm

Use of 3D ultrasound intraoperative before intraoperative MRI

No Intervention: retrospective matched pair arm

no use of intraoperative ultrasound before intraoperative MRI

Interventions

Device: - resection with help of 3D ultrasound

see above

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

University of Tübingen, Tübingen, Baden Würtemberg, Germany

Status

Recruiting

Address

University of Tübingen

Tübingen, Baden Würtemberg,

Site Contact

Constantin Roder, Prof. Dr. me.d

[email protected]

0822196

University of Ulm, Ulm, Germany

Status

Recruiting

Address

University of Ulm

Ulm, ,

Site Contact

Jan Coburger, MD

[email protected]

0822196

Stay Informed & Connected