Autoguide Positioning Device for Multiple Stereotactic Biopsies

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT06306118

Studienbeginn:
April 2024

Letztes Update:
12.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Brain Neoplasms

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Medical University of Graz

Collaborator:
-

Studienleiter

Stefan Wolfsberger, Prof.
Principal Investigator
Medical University of Graz

Kontakt

Alexander SG Micko, MD, PhD
Kontakt:
Phone: +43031638581257
E-Mail: alexander.micko@medunigraz.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Medical University of Graz
8036 Graz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Stefan Wolfsberger, Prof.
Phone: +43031638583102
E-Mail: stefan.wolfsberger@medunigraz.at» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Operations involving positioning of needles and catheters are amongst the most common

procedures in cranial neurosurgery. One of the most important matters that have to be

considered is that, submillimetric (<0.1 mm) precision is essential for the success of these

procedures. However, many biopsy needle procedures for obtaining tissue specimens are

currently performed with limited accuracy, i.e. using a mechanical arm. This could

potentially lead to procedural failure such as inconclusive tissue sampling and even major

complications, e.g. cerebral hemorrhage with consecutive neurologic deficits.

Therefore, navigation-guidance was implemented and established over the last two decades.

Using preoperatively compiled anatomical patient data from radiological images (Computerized

Tomography [CT] or Magnetic Resonance Imaging [MRI] scans) a trajectory from entry to target

point can be defined and matched intraoperatively on the patient's head.

In case of stereotactic needle biopsies, inaccuracy is associated with the acquisition of

non-diagnostic samples in up to 24% of stereotactic biopsy series or non-representative tumor

samples in up to 64% of biopsies. Therefore, serial biopsies could be performed to overcome

this drawback - associated with an increased risk of intracranial hemorrhages, which have

been reported in 0.3 - 59.8% of the cases and contribute considerably to the reported

morbidity of 0-16.1% of this procedure.

The Autoguide® system is a modular guidance system for surgical invasive tools which provides

a precise, submillimetric trajectory alignment according to the predefined navigation data.

After the development of this miniaturized robotic guidance system for neurosurgery was

successfully finalized, AutoGuide®, a robot for clinical application in neurosurgery, is now

commercially available from the Medtronic company.

Precision medicine requires highly accurate tissue sampling from radiologic targets. Thereby,

multiple targets on molecular imaging (e.g., MR-spectroscopy, PET) are of interest in many

cases. On the basis of the pathologist's diagnosis of these tissue samples, the oncologist

can provide patient-specific targeted therapy - a current standard practice in modern cancer

treatment.

The aim of this study is to perform a clinical series of multiple stereotactic needle

biopsies with the AutoGuide® system previous of brain tumor resection to achieve a more

accurate diagnosis of a possible hotspot within the tumor.

Prior to oncologic treatment, neurosurgical resection for maximum reduction of tumor cell

load is still the basis of brain tumor treatment. During surgery, tissue sampling is

performed manually by removing tumor tissue from hotspots as shown on the navigation system

screen. This method of tissue harvesting, however, is prone to considerable inaccuracy due to

the brain shift that occurs as soon as the craniotomy has been performed. High precision

targeting is therefore required for highly accurate tissue sampling from radiologic targets

to ensure correct postoperative therapy allocation.

A robotic system such as AutoGuide® has the potential to provide highly accurate tissue

samples from hotspots of interest prior to craniotomy. This allows to send a highly relevant

tumor sample to pathology for frozen section right at the very beginning of surgery for

decisions about further resection.

The major advantage in AutoGuide® performed surgeries lies in its rapid re-alignment if

multiple areas have to be targeted. Such "pre-resection biopsies" could be routinely

performed before brain tumor surgery with only minimal additional time expenditure and a more

accurate diagnosis of a hotspot area of the tumor.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- Age 18-80 years

- Diagnosis of a cerebral lesion with the indication for surgical resection

- Written informed consent to participate in the present study

- MRI and CT scanner compatibility

Exclusion Criteria:

- Pregnancy, breast feeding

- Patients not able to reason

- Age <18 or >80 years

- Claustrophobia

Studien-Rationale

Primary outcome:

1. Biopsy Results (Time Frame - 30 minutes to 1 hour (frozen section procedure)):
histopathological results (according to the WHO classification of CNS tumours) of the multiple biopsies will be matched with the results of the main tumor specimen

Geprüfte Regime

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.

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

"Autoguide Positioning Device for Multiple Stereotactic Biopsies"

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!