Ignite Creation Date:
2025-12-25 @ 4:27 AM
Ignite Modification Date:
2026-03-01 @ 6:00 AM
Study NCT ID:
NCT02960620
Status:
NO_LONGER_AVAILABLE
Last Update Posted:
2022-09-28
First Post:
2016-11-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therasphere for Unresectable Primary or Secondary Liver Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D008107', 'term': 'Liver Diseases'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}}, 'protocolSection': {'designModule': {'studyType': 'EXPANDED_ACCESS'}, 'statusModule': {'overallStatus': 'NO_LONGER_AVAILABLE', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'lastUpdateSubmitDate': '2022-09-27', 'studyFirstSubmitDate': '2016-11-08', 'studyFirstSubmitQcDate': '2016-11-08', 'lastUpdatePostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Humanitarian Device Exemption', 'Liver Disease', 'HDE #980006'], 'conditions': ['Liver Cancer', 'Liver Neoplasms', 'HepatoCellular Carcinoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://moffitt.org/clinical-trials-research/', 'label': 'Moffitt Cancer Center Clinical Trials website'}]}, 'descriptionModule': {'briefSummary': 'This is not a research study. The purpose is to provide supervised access to TheraSphere® therapy at this institution.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients will be recruited from the patient population referred to the principal clinician for regional liver cancer therapy.\n* Potential candidates are those diagnosed with primary or secondary liver neoplasia. The histopathology confirmation criterion may be waived in patients with a radiographically identifiable liver mass, known laboratory or clinical risk factors for cancer or elevated tumor markers and clinical findings. Guidelines from the American Association for the Study of Liver Diseases (AASLD) and the European Association for the Study of the Liver (EASL) describe in detail the approach and algorithm for diagnosing Hepatocellular Carcinoma (HCC).\n* Eastern Cooperative Oncology Group (ECOG) Performance Status Score 0 - 2\n* Life expectancy ≥ 3 months\n* \\> 4 weeks since prior radiation, surgery or chemotherapy\n* Able to comprehend and provide consent in accordance with institutional and federal guidelines\n\nExclusion Criteria:\n\n* Any other liver therapy planned for cancer treatment\n* Uncorrectable flow to the gastrointestinal tract\n* Estimated radiation doses to the lungs greater than 30 Gy in a single administration or 50 Gy in multiple administrations\n* Significant extrahepatic disease representing imminent life-threatening outcome\n* Pregnancy'}, 'identificationModule': {'nctId': 'NCT02960620', 'briefTitle': 'Therasphere for Unresectable Primary or Secondary Liver Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'H. Lee Moffitt Cancer Center and Research Institute'}, 'officialTitle': 'A Humanitarian Device Exemption (HDE) Treatment Protocol of TheraSphere® For Treatment of Unresectable Primary or Secondary Liver Neoplasia - HDE #980006', 'orgStudyIdInfo': {'id': 'MCC-15789'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TheraSphere Treatment', 'type': 'DEVICE', 'description': 'TheraSphere® is delivered into the liver tumor through a catheter placed into the hepatic artery. The hepatic artery provides the main blood supply to the tumor in the liver, whereas the portal vein supplies blood to normal liver parenchyma. TheraSphere® is embolized within the tumor and exerts a local beta radiation radiotherapeutic effect with relatively limited concurrent injury to surrounding normal tissue.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33612', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}], 'overallOfficials': [{'name': 'Junsung Choi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'H. Lee Moffitt Cancer Center and Research Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'H. Lee Moffitt Cancer Center and Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biocompatibles UK Ltd', 'class': 'INDUSTRY'}, {'name': 'BTG International Inc.', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}