Ignite Creation Date:
2025-12-24 @ 3:03 PM
Ignite Modification Date:
2026-02-10 @ 8:40 AM
Study NCT ID:
NCT01764659
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2013-01-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation
Sponsor:
Organization:
Raw JSON
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'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CE 3DCT', 'description': 'Contrast-enhanced 3DCT'}, {'id': 'OG001', 'title': '4DCT', 'description': '4DCT without contrast'}, {'id': 'OG002', 'title': 'CE 4DCT', 'description': 'Individually optimized contrast-enhanced 4DCT'}], 'classes': [{'title': 'Anatomic details', 'categories': [{'measurements': [{'value': '4.1', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '0.6', 'groupId': 'OG001'}, {'value': '3.6', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Motion artifacts', 'categories': [{'measurements': [{'value': '3.9', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.7', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Beam hardening', 'categories': [{'measurements': [{'value': '4.2', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.5', 'spread': '0.8', 'groupId': 'OG002'}]}]}, {'title': 'Enhancement of pancreatic tissue and tumor', 'categories': [{'measurements': [{'value': '3.2', 'spread': '1.0', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.9', 'groupId': 'OG001'}, {'value': '3.3', 'spread': '1.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.'}, {'type': 'PRIMARY', 'title': 'Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CE 3DCT', 'description': 'Contrast-enhanced 3DCT'}, {'id': 'OG001', 'title': '4DCT', 'description': '4DCT without contrast'}, {'id': 'OG002', 'title': 'CE 4DCT', 'description': 'Individually optimized contrast-enhanced 4DCT'}], 'classes': [{'title': 'Pancreas CT number (HU)', 'categories': [{'measurements': [{'value': '49.2', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '44.6', 'spread': '15.9', 'groupId': 'OG001'}, {'value': '75.5', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Tumor CT number (HU)', 'categories': [{'measurements': [{'value': '53.0', 'spread': '9.2', 'groupId': 'OG000'}, {'value': '58.9', 'spread': '14.3', 'groupId': 'OG001'}, {'value': '76.3', 'spread': '15.0', 'groupId': 'OG002'}]}]}, {'title': 'Tumor to pancreas contrast (HU)', 'categories': [{'measurements': [{'value': '15.5', 'spread': '20.7', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '12.3', 'groupId': 'OG002'}]}]}, {'title': 'Noise (HU)', 'categories': [{'measurements': [{'value': '12.5', 'spread': '3.9', 'groupId': 'OG000'}, {'value': '19.4', 'spread': '5.8', 'groupId': 'OG001'}, {'value': '22.1', 'spread': '5.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.', 'unitOfMeasure': 'HU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.'}, {'type': 'PRIMARY', 'title': 'Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'CE 3DCT', 'description': 'Contrast-enhanced 3DCT'}, {'id': 'OG001', 'title': '4DCT', 'description': '4DCT without contrast'}, {'id': 'OG002', 'title': 'CE 4DCT', 'description': 'Individually optimized contrast-enhanced 4DCT'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '0.6', 'spread': '0.7', 'groupId': 'OG001'}, {'value': '0.8', 'spread': '0.6', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 year', 'description': 'Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.', 'unitOfMeasure': 'contrast to noise ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Image data of 10 patients (of the 12 patients who completed the study) was good for analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Patients', 'description': 'Individually optimized CE 4D-CT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '12'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'GI Group', 'description': 'Study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '5', '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': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '9', '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-16', 'studyFirstSubmitDate': '2013-01-02', 'resultsFirstSubmitDate': '2017-08-22', 'studyFirstSubmitQcDate': '2013-01-07', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-03-16', 'studyFirstPostDateStruct': {'date': '2013-01-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2014-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Individually Optimized Contrast-enhanced 4DCT for Radiotherapy Simulation', 'timeFrame': '1 year', 'description': 'Image quality (anatomic details, motion artifacts, beam hardening and enhancement of pancreatic tissue and tumor were scored from 1 to 5, with 1 being very poor and 5 being excellent), CT number of pancreas and tumor, tumor-to-pancreas contrast, image noise and contrast-to-noise ration (CNR) were compared among contrast-enhanced (CE) 4DCT, CE 3DCT and 4DCT without contrast enhancement.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['4D-CT', 'Contrast Enhanced CT', 'Radiotherapy Simulation'], 'conditions': ['Pancreatic Adenocarcinoma']}, 'descriptionModule': {'briefSummary': 'The primary objective is to study the feasibility and efficacy of individually optimized CE 4D-CT for PDA in radiotherapy simulation.', 'detailedDescription': 'Compared with current clinical practice, the individually optimized CE 4D-CT can potentially provide much improved tumor-to-parenchyma conspicuity of pancreatic adenocarcinoma. This will help the radiation oncologists or radiologists to contour the tumor with higher precision and confidence, and compute the tumor volume and tumor motion more accurately.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'GI/GU multi-d clinic', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients 18 years old or older\n2. Patients with PDA who have not had surgical removal of their tumor and who are planned for treatment with radiotherapy in the Radiation Oncology Department at the University of Maryland.\n3. Patients who have signed the contrast consent form and have been recommended by physicians to have contrast-enhanced CT scans.\n4. Patients who have signed the consent form for this study\n\nExclusion Criteria:\n\n1. Pregnant or breast-feeding women.\n2. Patients with severely decreased renal function19-21.\n3. Patients with known severe allergic reactions to contrast.\n4. Patients who have difficulty lying flat on their back for extended periods of time.\n5. Patients with breaths per minute (BPM) rate less than 10, due to the limitation of 4D-CT image reconstruction software.'}, 'identificationModule': {'nctId': 'NCT01764659', 'acronym': 'GCC 1210', 'briefTitle': '4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation', 'organization': {'class': 'OTHER', 'fullName': 'University of Maryland, Baltimore'}, 'officialTitle': 'Individually Optimized Contrast-Enhancement 4D-CT for Pancreatic Adenocarcinoma in Radiotherapy Simulation', 'orgStudyIdInfo': {'id': 'HP-00052534'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'All enrolled patients', 'description': 'Contrast-enhanced 4D computed tomography', 'interventionNames': ['Other: Contrast-enhanced 4D computed tomography']}], 'interventions': [{'name': 'Contrast-enhanced 4D computed tomography', 'type': 'OTHER', 'description': 'All enrolled patients each underwent three CT scans: a 4DCT immediately following a contrast-enhanced 3DCT and an individually optimized contrast-enhanced 4DCT.', 'armGroupLabels': ['All enrolled patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Ummc Msgcc', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Wei Lu, Ph. D., DABR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMMC MSGCC'}, {'name': 'Hao H Zhang, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UMMC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Maryland, Baltimore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, Physics', 'investigatorFullName': 'Department of Radiation Oncology', 'investigatorAffiliation': 'University of Maryland, Baltimore'}}}}