Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-25 @ 7:36 PM
Study NCT ID:
NCT07197632
Status:
RECRUITING
Last Update Posted:
2025-09-29
First Post:
2025-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ioMRI in the Surgery of Brain Metastases.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 154}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-01-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2030-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-22', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-09-22', 'lastUpdatePostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-01-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'Through study completion, an average of 2 years'}], 'primaryOutcomes': [{'measure': 'Rate for complete resection', 'timeFrame': 'immediately after the surgery', 'description': 'The postoperative MRI obtained within 72 hours after surgery will be analyzed to identify the rates of resection.'}], 'secondaryOutcomes': [{'measure': 'Complications', 'timeFrame': 'Perioperatively', 'description': 'Hemorrhages, Ischemias, epileptic seizures, hydrocephalus, wound infection, Anesthesiological complications, neurological deficits'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ioMRI', 'Brain metastases', 'Neurosurgical resection'], 'conditions': ['Brain Metastases']}, 'descriptionModule': {'briefSummary': 'The study aims to improve the surgical treatment of brain metastases through the use of advanced imaging techniques. The investigators are examining how intraoperative MRI (iMRI) can aid surgeons in precisely locating and removing tumors, with the potential to enhance surgical outcomes and reduce the need for additional procedures. While iMRI offers the promise of better tumor visualization during surgery, it is also associated with longer surgical times and may carry the risk of increased complications. This study seeks to carefully evaluate these aspects to determine the overall benefits and challenges of iMRI in brain metastasis surgeries. The ultimate aim is to enhance treatment effectiveness and improve recovery and health outcomes for participants dealing with brain metastases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients for whom surgical resection of brain metastasis is indicated\n\nExclusion Criteria:\n\n* age \\< 18\n* 3T MRI contraindications'}, 'identificationModule': {'nctId': 'NCT07197632', 'acronym': 'MET-MRI', 'briefTitle': 'ioMRI in the Surgery of Brain Metastases.', 'organization': {'class': 'OTHER', 'fullName': 'Technical University of Munich'}, 'officialTitle': 'Evaluation of the Efficacy and Safety of Intraoperative MRI in the Surgery of Brain Metastases.', 'orgStudyIdInfo': {'id': '2024-452-S-KK Votum 12.12.2024'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Surgery without intraoperative MRI'}, {'type': 'EXPERIMENTAL', 'label': 'Surgery with intraoperative MRI', 'interventionNames': ['Procedure: Surgery with intraoperative MRI']}], 'interventions': [{'name': 'Surgery with intraoperative MRI', 'type': 'PROCEDURE', 'description': 'In this clinical study, we have the unique opportunity to utilize a 3 Tesla MRI intraoperatively during the surgical resection of brain metastases. This approach is distinctly different from standard procedures and offers several advantages. The use of a 3 Tesla MRI provides high-resolution imaging during surgery, offering unparalleled detail of brain structures and tumor boundaries. This level of imaging precision is typically not available in standard surgical procedures. Through real-time visualization, surgeons can better differentiate between tumor tissue and healthy brain tissue, potentially increasing the accuracy of tumor removal and minimizing damage to surrounding areas. Unlike conventional methods, this procedure allows for immediate intraoperative imaging feedback, enabling surgical teams to adjust their techniques dynamically', 'armGroupLabels': ['Surgery with intraoperative MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81675', 'city': 'Munich', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Maria Goldberg', 'role': 'CONTACT', 'email': 'maria.goldberg@tum.de', 'phone': '+498941402151'}], 'facility': 'Department of Neurosurgery, München University Hospital rechts der Isar (MRI)', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'centralContacts': [{'name': 'Maria Goldberg', 'role': 'CONTACT', 'email': 'maria.goldberg@tum.de', 'phone': '+498941402151'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Technical University of Munich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}