Ignite Creation Date:
2025-12-24 @ 9:44 PM
Ignite Modification Date:
2025-12-25 @ 7:24 PM
Study NCT ID:
NCT03427632
Status:
UNKNOWN
Last Update Posted:
2018-02-09
First Post:
2018-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001859', 'term': 'Bone Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001843', 'term': 'Bone Cements'}, {'id': 'D019904', 'term': 'Polymethyl Methacrylate'}], 'ancestors': [{'id': 'D012117', 'term': 'Resins, Synthetic'}, {'id': 'D010969', 'term': 'Plastics'}, {'id': 'D011108', 'term': 'Polymers'}, {'id': 'D046911', 'term': 'Macromolecular Substances'}, {'id': 'D001697', 'term': 'Biomedical and Dental Materials'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}, {'id': 'D008768', 'term': 'Methylmethacrylates'}, {'id': 'D011109', 'term': 'Polymethacrylic Acids'}, {'id': 'D000179', 'term': 'Acrylates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000180', 'term': 'Acrylic Resins'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 11}, 'targetDuration': '4 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-03-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-02-03', 'studyFirstSubmitDate': '2018-01-29', 'studyFirstSubmitQcDate': '2018-02-03', 'lastUpdatePostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-02-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain relief', 'timeFrame': 'immediate', 'description': 'reduction of spine pain following the injection of bone cement in the tumor according to Numeric Rating Scale, Improvement will be considered if NRS score decrease ≧ 20% after PVP'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PVP', 'bone tumor'], 'conditions': ['Bone Tumor']}, 'referencesModule': {'references': [{'pmid': '12687441', 'type': 'BACKGROUND', 'citation': 'Alvarez L, Perez-Higueras A, Quinones D, Calvo E, Rossi RE. Vertebroplasty in the treatment of vertebral tumors: postprocedural outcome and quality of life. Eur Spine J. 2003 Aug;12(4):356-60. doi: 10.1007/s00586-003-0525-z. Epub 2003 Mar 22.'}, {'pmid': '15746994', 'type': 'BACKGROUND', 'citation': 'Melton LJ 3rd, Kyle RA, Achenbach SJ, Oberg AL, Rajkumar SV. Fracture risk with multiple myeloma: a population-based study. J Bone Miner Res. 2005 Mar;20(3):487-93. doi: 10.1359/JBMR.041131. Epub 2004 Nov 29.'}, {'pmid': '11074686', 'type': 'BACKGROUND', 'citation': 'Wenger M, Markwalder TM. Re: Percutaneous vertebroplasty for pain relief and spinal stabilization (Spine 2000; 25: 923-8). Spine (Phila Pa 1976). 2000 Nov 15;25(22):2968-9. doi: 10.1097/00007632-200011150-00022. No abstract available.'}, {'pmid': '28105496', 'type': 'BACKGROUND', 'citation': 'Tsoumakidou G, Too CW, Koch G, Caudrelier J, Cazzato RL, Garnon J, Gangi A. CIRSE Guidelines on Percutaneous Vertebral Augmentation. Cardiovasc Intervent Radiol. 2017 Mar;40(3):331-342. doi: 10.1007/s00270-017-1574-8. Epub 2017 Jan 19.'}]}, 'descriptionModule': {'briefSummary': 'Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain for patients with vertebral tumors', 'detailedDescription': 'Destructive vertebral lesions are a common in metastatic disease, multiple myeloma and lymphoma. Symptoms are caused by pathologic fracture consequences secondary to vertebral destruction, development of spinal instability and compression of adjacent neurological elements. Nonoperative treatments include radiotherapy, hormone therapy, cytotoxic drugs which are effective to halt the osteolytic process and reverse the neurological compromise, however; they cannot provide stability or relieve pain or cord compression. Surgical management options including vertebrectomy, reconstruction with a cage or PMMA bone cement, and stabilization with pedicle screws can restore spinal canal support and neurological functions also control pain, however; usually associated with high postoperative morbidity and mortality. Also not advisable for multifocal spinal disease. Percutaneous vertebroplasty is a new technique to strengthen bone and reduce pain. It is percutaneous, minimally invasive, image-guided procedure that involves injection of radio-opaque bone cement into a partially collapsed vertebral body, in an effort to provide stability and pain relief. The exact mechanism of pain relief remains unclear. Proposed theories include more favourable biomechanics after cement strengthening, chemical toxicity and exothermic effect of cement polymerization on nerve endings.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '1 Year', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Male or female patients diagnosed with vertebral body metastasis, multiple myloma, lymphoma meet the inclusion and exclusion criteria.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Spinal instability\n* Pain with movement\n* Multiple level involvement\n* Expected survival 3-6 months\n\nExclusion Criteria:\n\n* Absolute\n* Asymptomatic\n* improving on medical treatment without worsening of the collapse.\n* infection local or systemic\n* uncorrectable coagulopathy\n* Allergy to bone cement or contrast media\n* Relative\n* Radicular pain\n* Tumor extension inside the vertebral canal or cord compression\n* Fracture of the posterior column\n* Sclerotic metastasis\n* Diffuse metastases'}, 'identificationModule': {'nctId': 'NCT03427632', 'acronym': 'PVP', 'briefTitle': 'Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Role of Percutaneous Vertebroplasty in Treatment of Vertebral Tumors', 'orgStudyIdInfo': {'id': 'PVPfortumors'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'percutaneous Vertebroplasty', 'description': 'patients meet the inclusion and exclusion criteria will be subjected to percutaneous vertebroplasty receiving bone cement (Polymethyl methacrylate)', 'interventionNames': ['Drug: Bone Cements']}], 'interventions': [{'name': 'Bone Cements', 'type': 'DRUG', 'otherNames': ['Polymethyl methacrylate'], 'description': 'patents in PVP group will get injected with bone cement inside the collapsed malignant vertebra', 'armGroupLabels': ['percutaneous Vertebroplasty']}]}, 'contactsLocationsModule': {'locations': [{'zip': '71515', 'city': 'Asyut', 'country': 'Egypt', 'contacts': [{'name': 'graduate studies, No', 'role': 'CONTACT', 'email': 'vp_grad@aun.edu.eg', 'phone': '+2088 22080150'}], 'facility': 'Assiut University hospital', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'centralContacts': [{'name': 'mustafa saed, MSc', 'role': 'CONTACT', 'email': 'msaed9939@gmail.com', 'phone': '01118894427'}], 'overallOfficials': [{'name': 'Nisreen Abbas, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mustafa syd', 'investigatorAffiliation': 'Assiut University'}}}}