Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 5:34 AM
Study NCT ID:
NCT06716294
Status:
RECRUITING
Last Update Posted:
2024-12-04
First Post:
2024-11-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D054854', 'term': 'Vertebroplasty'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D060826', 'term': 'Cementoplasty'}, {'id': 'D019637', 'term': 'Orthopedic Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 16}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2028-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-29', 'studyFirstSubmitDate': '2024-11-29', 'studyFirstSubmitQcDate': '2024-11-29', 'lastUpdatePostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PET', 'timeFrame': 'SUV measurement of PET in 24 hours', 'description': 'PET ACTIVITY'}], 'secondaryOutcomes': [{'measure': 'GBPI', 'timeFrame': '1 MONTH, 6 MONTHS, 12 MONTHS', 'description': 'NVS SCORE OF PAIN AND MOBLITY'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bone Cancer Metastatic', 'Radiofrequency Ablation', 'Spine Metastases', 'Vertebral Metastasis']}, 'descriptionModule': {'briefSummary': 'This pilot study will try to demonstrate metabolic changes in spine lesions treated by Augmentation and Ablation, according to existing standards of practice. Our purpose is to show the efficacy of a new radiofrequency radioablation (RFA) in combination with augmentation, using a percutaneous ablation device (Osteocool-Medtronic) in the treatment of secondary vertebral bone tumor, avoiding concurrent bias related to other treatments of the disease.', 'detailedDescription': 'Only patient supposed to undergo percutaneous vertebral augmentation for secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled. Lesions to be treated must be metabolically active on PET-CT, performed during the last month. Patients will be informed and sign and inform consent. Patients will be treated with Augmentation and Ablation (Osteocool-Medtronic). Post treatment patients will be submitted to a new PET-CT in order to verify activity on treated site.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '* Sixteen (16) patients will be enorolled.\n* \\- only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.\n* lesions to be treated must be metabolically active on PET-CT performed during the last month.\n* Patients will be informed and sould sign an inform consent.\n* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* only patients with secondary osteolytic and mixed (lytic and sclerotic) spine tumors with one to three active lesions will be enrolled.\n* lesions to be treated must be metabolically active on PET-CT performed during the last month.\n* Patients will be informed and sould sign an inform consent.\n* post treatment patients should submittes a new PET-CT in order to verify the activity of the treated area.\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT06716294', 'acronym': 'ABLASPINE', 'briefTitle': 'Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation', 'organization': {'class': 'OTHER', 'fullName': 'National and Kapodistrian University of Athens'}, 'officialTitle': 'Effectiveness Of Radiofrequency Ablation And Stabilization In Metastatic Spine Lesions By PET Confirmation', 'orgStudyIdInfo': {'id': '46351/2020'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiofrequency Ablation and Bone Augmentation', 'type': 'DEVICE', 'otherNames': ['Vertebroplasty'], 'description': 'Percutaneous Tumor Ablation of Spine Lesions followed by Polymer Augmentation'}]}, 'contactsLocationsModule': {'locations': [{'zip': '12462', 'city': 'Athens', 'state': 'Haidari', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Alexis Kelekis', 'role': 'CONTACT', 'email': 'akelekis@hotmail.com', 'phone': '+306932580787'}], 'facility': 'Attikon General University Hospital', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}], 'centralContacts': [{'name': 'Alexis Kelekis, MD PHD, EBIR', 'role': 'CONTACT', 'email': 'akelekis@med.uoa.gr', 'phone': '+302105831806'}, {'name': 'MARIA IOANNIDI, MD', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'ALEXIOS KELEKIS, MD, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National and Kapodistrian University of Athens, Greece'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National and Kapodistrian University of Athens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PROFESSOR OF DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY', 'investigatorFullName': 'Alexis Kelekis', 'investigatorAffiliation': 'National and Kapodistrian University of Athens'}}}}