Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2026-01-24 @ 8:41 AM
Study NCT ID:
NCT01071434
Status:
TERMINATED
Last Update Posted:
2012-12-07
First Post:
2009-12-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D055752', 'term': 'Small Cell Lung Carcinoma'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'whyStopped': 'PI left', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-05', 'studyFirstSubmitDate': '2009-12-16', 'studyFirstSubmitQcDate': '2010-02-18', 'lastUpdatePostDateStruct': {'date': '2012-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.', 'timeFrame': 'two hours'}]}, 'conditionsModule': {'conditions': ['Pancreatic Cancer', 'Liver Cancer', 'Lung Cancer', 'Lung Cancer Non-Small Cell Cancer (NSCLC)', 'Lung Cancer Small Cell Lung Cancer (SCLC)', 'Hepatobiliary Cancers', 'Hepatobiliary Cancers Liver', 'Hepatobiliary Cancers Hepatocellular Carcinoma (Hepatoma)', 'Hepatobiliary Cancers Gallbladder', 'Hepatobiliary Cancers Bile Duct']}, 'descriptionModule': {'briefSummary': 'This study aims to investigate and optimize imaging sequences and parameters of rapid real-time MRI in order to obtain adequate guidance for accurately and precisely delivering radiation to moving abdominal and thoracic tumors.', 'detailedDescription': 'Accurate dose delivery remains one of the weakest aspects of radiotherapy, especially in the case of thoracic and abdominal tumors, where significant patient motion occurs during dose delivery (intrafraction motion). Such motion results in geometric and dosimetric uncertainties that compromise treatment quality. Effective management of intrafraction motion is therefore key to realizing the full potential of modern image-guided radiation therapy (IGRT). While external markers have been found to be well-correlated with internal anatomy within an imaging session, there is no guarantee that these correlations will continue to exist and be constant throughout the course of the therapy. In general, implanted, radio-opaque seeds have been found to be more reliable than external markers. However, implantation of fiducials, whether radio-opaque or electromagnetic, is necessarily invasive and carries with it the risk of associated complications - an issue that becomes especially important for cancer patients with weakened immune systems. Currently, MR imaging is the only modality that is non-invasive and provides high quality volumetric information for the whole body.\n\nThe "ideal" intrafraction motion management requires complete spatio-temporal knowledge of the irradiated anatomy. However, to date, there is no clinical method of directly visualizing the tumor volume during dose delivery. Most techniques rely on external or internal surrogate markers which often provide (usually non-volumetric) information of limited accuracy and reliability. In addition, internal markers impose significant "costs" on the patient in terms of interventional complications and increased imaging dose. In this work, we investigate the feasibility of using in-room, fast cine MR imaging as a non-invasive means to provide real-time, soft-tissue-based, volumetric image guidance for continuous monitoring of the target and surrounding anatomy. To date, there has been no systematic investigation of the imaging requirements of an integrated MRI+linac for the specific task of real-time radiotherapy guidance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eligible disease(s)/stage(s) \\\\AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:3.1.1. Eligible disease(s)/stage(s) \\\\AJCC Stage I, II, III or IV lung, liver or pancreatic cancer of any histology to be treated using radiotherapy will be eligible for this study.\n\n3.1.2. Allowable type and amount of prior therapy \\ Any types and amounts of prior therapy will be allowed for this study.\n\n3.1.3. Age restriction and/or gender/ethnic restrictions \\\\Patients must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions.\n\n3.1.4. Life expectancy restrictions \\ None.\n\n3.1.5. ECOG or Karnofsky Performance Status \\ Karnofsky performance status of 50 or greater\n\n3.1.6. Requirements for organ and marrow function \\ None.\n\n3.1.7. Ability to understand and the willingness to sign a written informed consent document.\n\n3.1.8. Pain-free in supine position Exclusion Criteria:3.2.1 Children (age \\<18)\n\n3.2.2 Metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers\n\n3.2.3 Women who are pregnant or trying to get pregnant\n\n3.2.4 Pain in supine position\n\n3.2.5 Karnofsky performance status \\< 50'}, 'identificationModule': {'nctId': 'NCT01071434', 'briefTitle': 'Feasibility of Using Real-time Cine-MRI for Treating Moving & Deforming Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Investigating the Feasibility of Using Real-time Cine-MRI for Treating Moving and Deforming Tumors', 'orgStudyIdInfo': {'id': 'VAR0042'}, 'secondaryIdInfos': [{'id': 'SU-06112009-2702', 'type': 'OTHER', 'domain': 'Stanford University'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'MR Imaging', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Amit Sawant', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}, {'name': 'Paul J Keall', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'The American Association of Physicists in Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}