Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2026-03-16 @ 10:49 AM
Study NCT ID:
NCT06548061
Status:
RECRUITING
Last Update Posted:
2025-04-03
First Post:
2023-03-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
D20054;LITT for Spine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 25}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2023-03-09', 'studyFirstSubmitQcDate': '2024-08-05', 'lastUpdatePostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local tumor control', 'timeFrame': 'Local control rate at 12 months', 'description': 'Any increase in the epidural spinal cord compression score (ESCC grade 1 (no compression) to 3 (spinal cord compression) compared to the initial post-procedure MRI will be considered local radiographic failure or evidence of tumor recurrence.'}], 'secondaryOutcomes': [{'measure': 'Evaluate neurologic function before and after sLITT.', 'timeFrame': '3, 6, 9, and 12 months post-operatively', 'description': 'Using Frankel score. Frankel scores (scale form A to E where A= complete loss of motor and sensory function, B= complete motor paralysis but some sensory function, C= some motor function but not usable, D= weakened but usable motor function, E= neurologically intact)'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Spinal Metastases']}, 'descriptionModule': {'briefSummary': 'The objective of this clinical study is to evaluate the efficacy and safety of spinal laser interstitial therapy in the treatment of metastatic spinal tumors. The investigators hypothesize that rates of local tumor control are comparable between conventional open surgical techniques and spinal laser interstitial therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histology confirmed spinal tumor involving the T2-T12 spine segments.\n2. Indication for spine stereotactic radiosurgery or palliative intervention.\n3. Normal neurologic exam at the time of presentation (Frankel grade E).\n\nExclusion Criteria:\n\n1. Contraindication to MRI\n2. ANY neurologic deficit\n3. Tumor spanning more than 3 consecutive vertebral segments\n4. Contraindication to general anesthesia\n5. Pregnancy'}, 'identificationModule': {'nctId': 'NCT06548061', 'briefTitle': 'D20054;LITT for Spine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Dartmouth-Hitchcock Medical Center'}, 'officialTitle': 'Single Center Observational Study Using Spinal Laser Interstitial Thermal Therapy (sLITT) in the Treatment of Spine Metastases and Tumors', 'orgStudyIdInfo': {'id': 'STUDY02001761'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Spinal Laser Interstitial Thermal Therapy (sLITT)', 'description': 'Patients will undergo surgery utilizing the Visualase Thermal Therapy System (Medtronic) device.', 'interventionNames': ['Device: Visualase Thermal Therapy System']}], 'interventions': [{'name': 'Visualase Thermal Therapy System', 'type': 'DEVICE', 'description': 'Spine laser interstitial therapy used instead of open decompression followed by spine stereotactic radiosurgery (SSRS).', 'armGroupLabels': ['Spinal Laser Interstitial Thermal Therapy (sLITT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03766', 'city': 'Lebanon', 'state': 'New Hampshire', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lauren Sinks, MPH', 'role': 'CONTACT', 'email': 'lauren.j.sinks@hitchcock.org', 'phone': '603-650-6380'}], 'facility': 'Dartmouth Health', 'geoPoint': {'lat': 43.64229, 'lon': -72.25176}}], 'centralContacts': [{'name': 'Lauren Sinks, MPH', 'role': 'CONTACT', 'email': 'lauren.j.sinks@hitchcock.org', 'phone': '603-650-6380'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dartmouth-Hitchcock Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Neuro-oncology, Principle Investigator, Assistant Professor', 'investigatorFullName': 'Linton T. Evans', 'investigatorAffiliation': 'Dartmouth-Hitchcock Medical Center'}}}}