Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT06306118
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2023-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Autoguide Positioning Device for Multiple Stereotactic Biopsies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Routine neuropathological examination of biopsies from areas of expected highest malignancy by PET (Positron Emission Tomography) or MRS (Magnetic Resonance Spectroscopy) scans'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-02', 'studyFirstSubmitDate': '2023-11-07', 'studyFirstSubmitQcDate': '2024-03-07', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biopsy Results', 'timeFrame': '30 minutes to 1 hour (frozen section procedure)', 'description': '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'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['autoguide', 'tumor biopsy', 'stereotatic', 'undergrading'], 'conditions': ['Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nOn 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.\n\nTo 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.', 'detailedDescription': '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.\n\nTherefore, 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.\n\nIn 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.\n\nThe Autoguide® system is a modular guidance system for surgical invasive tools which provides a precise, submillimetric trajectory alignment according to the predefined navigation data.\n\nAfter 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.\n\nPrecision 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.\n\nThe 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.\n\nPrior 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.\n\nA 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a preoperative suspected low grade glioma, in whom a tumor resection is planned.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-80 years\n* Diagnosis of a cerebral lesion with the indication for surgical resection\n* Written informed consent to participate in the present study\n* MRI and CT scanner compatibility\n\nExclusion Criteria:\n\n* Pregnancy, breast feeding\n* Patients not able to reason\n* Age \\<18 or \\>80 years\n* Claustrophobia'}, 'identificationModule': {'nctId': 'NCT06306118', 'acronym': 'AMB', 'briefTitle': 'Autoguide Positioning Device for Multiple Stereotactic Biopsies', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Graz'}, 'officialTitle': 'Application of the Autoguide® Positioning Device for Multiple Stereotactic Tumor Biopsies During a Brain Tumor Resection', 'orgStudyIdInfo': {'id': '35-046 ex 22/23'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Multiple stereotactic Tumor Biopsies during a Brain Tumor Resection', 'type': 'DEVICE', 'description': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '8036', 'city': 'Graz', 'state': 'Styria', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Stefan Wolfsberger, Prof.', 'role': 'CONTACT', 'email': 'stefan.wolfsberger@medunigraz.at', 'phone': '+43031638583102'}], 'facility': 'Medical University of Graz', 'geoPoint': {'lat': 47.06733, 'lon': 15.44197}}], 'centralContacts': [{'name': 'Alexander SG Micko, MD, PhD', 'role': 'CONTACT', 'email': 'alexander.micko@medunigraz.at', 'phone': '+43031638581257'}], 'overallOfficials': [{'name': 'Stefan Wolfsberger, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Medical University of Graz'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Graz', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}