Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-27 @ 11:05 PM
Study NCT ID:
NCT03986593
Status:
TERMINATED
Last Update Posted:
2023-07-05
First Post:
2019-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cryoablation of Bone Metastases From Endocrine Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D010673', 'term': 'Pheochromocytoma'}, {'id': 'D000310', 'term': 'Adrenal Gland Neoplasms'}, {'id': 'D018358', 'term': 'Neuroendocrine Tumors'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}, {'id': 'D010235', 'term': 'Paraganglioma'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D000307', 'term': 'Adrenal Gland Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'open, single-arm group, prospective'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}}, 'statusModule': {'whyStopped': 'The study achieved n=17 participants (56.6% of the initial proposition) with a mean = 18 months follow-up. All patients completed 12 months follow-up or deceased. We chose to terminate and publish the data available.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-09-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2023-05-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-30', 'studyFirstSubmitDate': '2019-05-22', 'studyFirstSubmitQcDate': '2019-06-11', 'lastUpdatePostDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in the local disease status of the cryoablation treated bone metastases', 'timeFrame': 'baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months', 'description': 'absence of neurological impairment and/or pain evaluated by clinical examination and brief pain inventory forms avoiding additional radiation therapy or surgery need'}], 'secondaryOutcomes': [{'measure': 'evaluation of pain control', 'timeFrame': 'baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months', 'description': 'evaluation of pain control with the help of Brief Pain Inventory forms'}, {'measure': 'evaluation of quality of life', 'timeFrame': 'baseline (preprocedure), 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months', 'description': 'evaluation of quality of life with the help of Brief Pain Inventory forms'}, {'measure': 'number of participants with treatment-related adverse events according to CTCAE 5.0', 'timeFrame': 'baseline (preprocedure); 01 week, 01 month, 03 months, 06 months, 12 months, 18 months, 24 months', 'description': 'Major complications rates below 10%; Minor complication rates below 15%; Side effects rates bellow 20%; according to general guidelines (Society of Interventional Radiology - SIR);'}, {'measure': 'imaging evaluation (CT or MRI)', 'timeFrame': 'baseline (preprocedure); 03 months, 06 months, 12 months, 24 months', 'description': 'Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions'}, {'measure': 'functional imaging evaluation (PET-CT)', 'timeFrame': 'baseline (preprocedure); immediate post-procedure; 06 months', 'description': 'Computed tomography or Magnetic resonance imaging evaluation of eligible treated lesions'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Neoplasm Metastasis', 'Thyroid Neoplasm', 'Pheochromocytoma', 'Adrenal Neoplasm', 'Neuroendocrine Tumors', 'Bone Metastases']}, 'referencesModule': {'references': [{'pmid': '21170528', 'type': 'BACKGROUND', 'citation': 'de Freitas RM, de Menezes MR, Cerri GG, Gangi A. Sclerotic vertebral metastases: pain palliation using percutaneous image-guided cryoablation. Cardiovasc Intervent Radiol. 2011 Feb;34 Suppl 2:S294-9. doi: 10.1007/s00270-010-0085-7. Epub 2010 Dec 18.'}, {'pmid': '12091666', 'type': 'BACKGROUND', 'citation': 'Callstrom MR, Charboneau JW, Goetz MP, Rubin J, Wong GY, Sloan JA, Novotny PJ, Lewis BD, Welch TJ, Farrell MA, Maus TP, Lee RA, Reading CC, Petersen IA, Pickett DD. Painful metastases involving bone: feasibility of percutaneous CT- and US-guided radio-frequency ablation. Radiology. 2002 Jul;224(1):87-97. doi: 10.1148/radiol.2241011613.'}, {'pmid': '21500132', 'type': 'BACKGROUND', 'citation': 'Munk PL, Murphy KJ, Gangi A, Liu DM. Fire and ice: percutaneous ablative therapies and cement injection in management of metastatic disease of the spine. Semin Musculoskelet Radiol. 2011 Apr;15(2):125-34. doi: 10.1055/s-0031-1275595. Epub 2011 Apr 15.'}, {'pmid': '29734509', 'type': 'BACKGROUND', 'citation': 'Ferrer-Mileo L, Luque Blanco AI, Gonzalez-Barboteo J. Efficacy of Cryoablation to Control Cancer Pain: A Systematic Review. Pain Pract. 2018 Nov;18(8):1083-1098. doi: 10.1111/papr.12707. Epub 2018 Jun 7.'}, {'pmid': '23065947', 'type': 'BACKGROUND', 'citation': 'Callstrom MR, Dupuy DE, Solomon SB, Beres RA, Littrup PJ, Davis KW, Paz-Fumagalli R, Hoffman C, Atwell TD, Charboneau JW, Schmit GD, Goetz MP, Rubin J, Brown KJ, Novotny PJ, Sloan JA. Percutaneous image-guided cryoablation of painful metastases involving bone: multicenter trial. Cancer. 2013 Mar 1;119(5):1033-41. doi: 10.1002/cncr.27793. Epub 2012 Oct 12.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the clinical response and safety of cone beam computed-tomography guided percutaneous cryoablation in bone metastases from thyroid, adrenal and neuroendocrine tumors in 30 patients.', 'detailedDescription': 'Thyroid neoplasms, as well as adrenal and neuroendocrine tumors have the potential to metastasize to bone. About 3% of patients with well-differentiated thyroid carcinomas develop secondary bone lesions, while adrenal and neuroendocrine tumors have 10% and 13% bone metastases rates, respectively. Spinal metastases are associated to a worst prognosis. The progressive systemic disease, the post-operative complications, and the pre-operative neurologic impairment were associated to a worst global survival rate in the thyroid cancer. Additionally, extensive spinal instrumentation of metastatic thyroid carcinoma was associated to greater complication rates. Interventional radiology offers promising techniques for the minimally invasive approach of bone metastases. Image-guided percutaneous radiofrequency ablation and cryoablation techniques have been studied in clinical trials and are considered effective options in pain palliation of patients with bone metastatic disease. These techniques may be associated with conventional treatment, as well as radiation therapy and percutaneous embolization, avoiding major surgical interventions and its complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with bone metastases from thyroid, adrenal or neuroendocrine tumor diagnosis, associated to one of the following: pain; risk fracture; risk of compression of spinal cord; hypercalcemia; performance status (ECOG) 0-3; mean life expectancy over one month;\n\nExclusion Criteria:\n\n* age \\< 18 years\n* active anticoagulant therapy or uncorrectable coagulopathy\n* pregnancy or breast feeding'}, 'identificationModule': {'nctId': 'NCT03986593', 'briefTitle': 'Cryoablation of Bone Metastases From Endocrine Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Instituto do Cancer do Estado de São Paulo'}, 'officialTitle': 'Cone-beam Computed Tomography Guided Percutaneous Cryoablation of Bone Metastases From Endocrine Tumors', 'orgStudyIdInfo': {'id': '990/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Cryoablation +- cementoplasty treated patients', 'description': 'cone beam computed tomography guided cryoablation +- cementoplasty', 'interventionNames': ['Device: cryoablation']}], 'interventions': [{'name': 'cryoablation', 'type': 'DEVICE', 'description': 'cryoablation of bone metastases by cone beam-CT image-guidance', 'armGroupLabels': ['Cryoablation +- cementoplasty treated patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246000', 'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Instituto do Cancer do Estado de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Ricardo MC Freitas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Instituto do Cancer do Estado de São Paulo'}]}, 'ipdSharingStatementModule': {'timeFrame': 'Data will become available within 18 months of study completion and for 6 months.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data for all primary and secondary outcome measures will be made available.\n\nSupporting information: Study protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR); Analytic Code; Time frame: Data will be available within 18 months of study completion. Access Criteria: Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.', 'accessCriteria': 'Data access requests will be reviewed by an external Independent Review Panel. Requestors will be required to sign a Data Access Agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto do Cancer do Estado de São Paulo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}