Ignite Creation Date:
2025-12-26 @ 2:43 PM
Ignite Modification Date:
2025-12-26 @ 2:43 PM
Study NCT ID:
NCT04563806
Status:
TERMINATED
Last Update Posted:
2022-07-11
First Post:
2020-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D008279', 'term': 'Magnetic Resonance Imaging'}], 'ancestors': [{'id': 'D014054', 'term': 'Tomography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DEVICE_FEASIBILITY', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'whyStopped': 'Per PI', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-07', 'studyFirstSubmitDate': '2020-06-10', 'studyFirstSubmitQcDate': '2020-09-20', 'lastUpdatePostDateStruct': {'date': '2022-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of intraoperative adverse events', 'timeFrame': 'During surgery', 'description': 'Safety will be assessed as a dichotomous variable. Frequencies and descriptive statistics of the outcomes under study will be performed. 95% confidence intervals will be computed. Other ad-hoc analyses may be performed as well.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thoracic Spine Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'M D Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'This trial investigates the safety and accuracy of using 2 pieces of hardware (a clamp and a needle) that are able to be used with magnetic resonance imaging (MRI) during spinal surgery. During a standard spinal surgery, a computed tomography (CT) scan is used to help plan the placement of surgical instruments used during the procedure or for needle biopsies. Then, the patient is moved to the MRI. For this study, the patient is able to stay in place as the hardware used in this study is able to work with the MRI. Using MRI compatible hardware may allow for an extra degree of safety and facilitate better surgical workflow.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To document the safety of utilizing MRI compatible hardware for intraoperative MRI-based image guidance to perform percutaneous spinal procedures.\n\nSECONDARY OBJECTIVE:\n\nI. To determine the accuracy of the MRI-based image guidance.\n\nOUTLINE:\n\nPatients undergo standard of care spine surgery with MRI-based image guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing percutaneous spinal procedures requiring image guidance at MD Anderson\n* Age \\> 18 years old. (The indication for this technique is controversial in skeletally immature patients.)\n* All diagnoses are eligible\n* Vertebral body site to be treated located from T2 to T12\n* Signed informed consent\n\nExclusion Criteria:\n\n* Requires open spinal procedure or a percutaneous procedure without the use of image guidance\n* Unable to tolerate general anesthesia and prone position\n* Unable to undergo MRI scan of the spine'}, 'identificationModule': {'nctId': 'NCT04563806', 'briefTitle': 'Safety of MRI Compatible Hardware for MRI-based Image Guidance During Spine Surgery', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'A Pilot Study to Evaluate the Safety of MRI Compatible Hardware for Intraoperative MRI-Based Image Guidance for Spinal Procedures', 'orgStudyIdInfo': {'id': '2017-0663'}, 'secondaryIdInfos': [{'id': 'NCI-2020-03700', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '2017-0663', 'type': 'OTHER', 'domain': 'M D Anderson Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device feasibility (MRI-guided surgery)', 'description': 'Patients undergo standard of care spine surgery with MRI-based image guidance.', 'interventionNames': ['Device: Magnetic Resonance Imaging', 'Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Magnetic Resonance Imaging', 'type': 'DEVICE', 'otherNames': ['Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo MRI-guided surgery', 'armGroupLabels': ['Device feasibility (MRI-guided surgery)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo spinal surgery', 'armGroupLabels': ['Device feasibility (MRI-guided surgery)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M D Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Claudio E Tatsui', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}