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Autoguide Positioning Device for Multiple Stereotactic Biopsies

NCT06306118 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 25

Last updated 2025-04-03

No results posted yet for this study

Summary

The purpose of this clinical study should be that, in the context of planned resections of glial brain tumors, pieces of tissue (biopsies) are removed from the tumor at several specific locations before the actual tumor resection takes place.

The aim of these biopsies in advance to the actual tumor resection will be to receive tumor tissue samples not altered in such a way that it is no longer adequate for further treatment. If not adequate, a so-called "undergrading" could occur, which means that the biological structure of the tumor is misjudged and further therapy does not achieve the desired effect in the patient.

On the one hand, certain tumor regions can drift due to a "brain shift" which leads to inaccurate tissue removal, and on the other hand samples are not altered by pressure or bleeding.

To carry out these biopsies, a robot positioning device (AutoGuide®) will be used that has already been approved and tested for this type of intervention. The use of the AutoGuide® is intended to ensure that the tumor sample is taken with the greatest possible precision.

Conditions

  • Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection

Interventions

DEVICE

Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection

For pre-resection biopsy cases (3 target per patient), the targets will be selected from metabolite hotspots on MR-spectroscopy imaging and/or amino acid tracer uptake hotspots on PET imaging. Depending on the tumor location and surgical procedure, all biopsies will be performed via one single or multiple entry points.

Sponsors & Collaborators

  • Medical University of Graz

    lead OTHER

Principal Investigators

  • Stefan Wolfsberger, Prof. · Medical University of Graz

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2025-05-31
Completion
2025-10-31
FDA Device
Yes

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06306118 on ClinicalTrials.gov