Ignite Creation Date:
2025-12-24 @ 4:23 PM
Ignite Modification Date:
2026-01-04 @ 6:39 PM
Study NCT ID:
NCT03824366
Status:
COMPLETED
Last Update Posted:
2025-01-10
First Post:
2019-01-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2022-12-14', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}, {'id': 'D006469', 'term': 'Hemoptysis'}, {'id': 'D006471', 'term': 'Gastrointestinal Hemorrhage'}, {'id': 'D013479', 'term': 'Superior Vena Cava Syndrome'}, {'id': 'D008477', 'term': 'Mediastinal Diseases'}], 'ancestors': [{'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013896', 'term': 'Thoracic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'kim.hyun@wustl.edu', 'phone': '314-362-8502', 'title': 'Hyun Kim, M.D.', 'organization': 'Washington University School of Medicine'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events and all-cause mortality were tracked through 1 week following the last day of MRgRT, an average of 2 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'Volumetric MR Imaging Planning', 'description': '* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.\n* Patients will receive standard of care palliative radiation therapy', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 6, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'seriousEvents': [{'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Death due to disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Volumetric MR Imaging Planning', 'description': '* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.\n* Patients will receive standard of care palliative radiation therapy'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Completion of enrollment (approximately 29 months)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Volumetric MR Imaging Planning', 'description': '* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.\n* Patients will receive standard of care palliative radiation therapy'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Previously unidentified metal artifact', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Unable to tolerate lying flat on MR table', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Patients would be considered evaluable for the study if they were able to be scheduled for radiation treatment per protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Volumetric MR Imaging Planning', 'description': '* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.\n* Patients will receive standard of care palliative radiation therapy'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'groupId': 'BG000', 'lowerLimit': '28', 'upperLimit': '90'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-01-25', 'size': 429325, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-11-14T08:36', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-26', 'studyFirstSubmitDate': '2019-01-29', 'resultsFirstSubmitDate': '2022-11-21', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-01-04', 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Feasibility of Same-session MRI-only Simulation as Defined as More Than 70% of Patients Receiving at Least 70% of Their Scheduled Treatment Fractions on the First On-table Attempt for Each Respective Fraction.', 'timeFrame': 'Completion of enrollment (approximately 29 months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Malignancy', 'Metastasis', 'Hemoptysis', 'Gastrointestinal Bleeding', 'Pelvic Bleeding', 'Superior Vena Cava Syndrome', 'Mediastinal Disease']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'This proposed study is unique in that patients will not undergo computed tomography (CT) simulation at any point during their treatment course and will instead have same-session magnetic resonance (MR)-only simulation and treatment planning, on-table, using the adaptive radiotherapy (ART) workflow. In this manner, patients requiring urgent treatment could initiate treatment as early as the day of initial radiation oncology consultation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of malignancy (biopsy proven or high clinical suspicion with urgent/emergent clinical indications for palliative RT)\n* Requires delivery of palliative radiation therapy for the treatment of painful metastasis, hemoptysis, gastrointestinal bleeding, pelvic bleeding, or superior vena cava syndrome/bulky mediastinal disease.\n* At least 18 years of age.\n* Able to understand and willing to sign an IRB-approved written informed consent document.\n\nExclusion Criteria:\n\n* Pregnant. Patients of childbearing potential must have a negative pregnancy test within 14 days of study entry.\n* Medical contraindication to undergoing MR imaging.'}, 'identificationModule': {'nctId': 'NCT03824366', 'acronym': 'MAP-RT', 'briefTitle': 'Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Pilot Study of Same-session MR-only Simulation and Treatment With MRI-guided Adaptive Palliative RadioTherapy (MAP-RT)', 'orgStudyIdInfo': {'id': '201901172'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Volumetric MR imaging planning', 'description': '* All patients will undergo volumetric MR imaging on treatment days in positioning appropriate for the specific treatment site.\n* Patients will receive standard of care palliative radiation therapy', 'interventionNames': ['Device: Volumetric MR imaging', 'Radiation: Radiation therapy']}], 'interventions': [{'name': 'Volumetric MR imaging', 'type': 'DEVICE', 'description': 'This will most frequently be supine with arms positioned so not in the way of treatment beams.', 'armGroupLabels': ['Volumetric MR imaging planning']}, {'name': 'Radiation therapy', 'type': 'RADIATION', 'description': '-Standard of care', 'armGroupLabels': ['Volumetric MR imaging planning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Hyun Kim, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Beginning 3 months and ending 5 years following article publication', 'ipdSharing': 'YES', 'description': 'Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices). Participants who opted out of data sharing in the informed consent will not be included.', 'accessCriteria': 'Researches must provide a methodologically sound proposal. Proposals should be directed to kim.hyun@wustl.edu. To gain access, data requestors will need to sign a data access agreement and provide proof of appropriate regulatory approvals as necessary.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}