Ignite Creation Date:
2025-12-25 @ 4:46 AM
Ignite Modification Date:
2025-12-26 @ 3:48 AM
Study NCT ID:
NCT01004718
Status:
COMPLETED
Last Update Posted:
2021-05-18
First Post:
2009-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008223', 'term': 'Lymphoma'}], 'ancestors': [{'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'C000615276', 'term': 'Fluorine-18'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}], 'ancestors': [{'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ellen.napier@pennmedicine.upenn.edu', 'phone': '215.279.1972', 'title': 'Ellen Napier, CRNP', 'organization': 'University of Pennsylvania'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Fludeoxyglucose F18 (FDG) PET/CT Scans', 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.', 'otherNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Diffuse Large B-cell Lymphoma', 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.'}, {'id': 'OG001', 'title': "Hodgkin's Lymphoma", 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.2', 'spread': '12.4', 'groupId': 'OG000'}, {'value': '32', 'spread': '11.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '2 hours (between 60 minutes post-administration and 180 minutes post-administration)', 'description': 'Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).', 'unitOfMeasure': 'percentage of change in maximum SUV', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Fludeoxyglucose F18 (FDG) PET/CT Scans', 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.\n\nFludeoxyglucose F18: Undergo FDG PET/CT scans\n\nComputed Tomography: Undergo FDG PET/CT scans\n\nPositron emission tomography: Undergo FDG PET/CT scans'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Fludeoxyglucose F18 (FDG) PET/CT Scans', 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.\n\nFludeoxyglucose F18: Undergo FDG PET/CT scans\n\nComputed Tomography: Undergo FDG PET/CT scans\n\nPositron emission tomography: Undergo FDG PET/CT scans'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'BG000', 'lowerLimit': '25', 'upperLimit': '69'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'dispFirstSubmitDate': '2020-04-13', 'completionDateStruct': {'date': '2014-11-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2009-10-29', 'dispFirstSubmitQcDate': '2020-04-14', 'resultsFirstSubmitDate': '2020-09-11', 'studyFirstSubmitQcDate': '2009-10-29', 'dispFirstPostDateStruct': {'date': '2020-04-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2021-04-27', 'studyFirstPostDateStruct': {'date': '2009-10-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage Change in Maximum Lesional FDG Uptake From 60 to 180 Minutes After FDG Administration', 'timeFrame': '2 hours (between 60 minutes post-administration and 180 minutes post-administration)', 'description': 'Lesional fluorodeoxyglucose (FDG) uptake is measured by standardized uptake value (SUV). The study compared the percentage of change in maximum SUV over 2 hours (first measure was 60 minutes post-administration and second timepoint was 180 minutes post-administration).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lymphoma']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Imaging procedures, such as positron emission tomography or computed tomography, may help in detecting differences between Hodgkin lymphoma or diffuse large B-cell lymphoma cancer cells. PURPOSE: This clinical trial is studying positron emission tomogaphy and computed tomography in determining differences in Hodgkin lymphoma and diffuse large B-cell lymphoma.', 'detailedDescription': 'OBJECTIVES:\n\nI. Assess the feasibility of detection and quantification of differences in the temporal and spatial distribution of FDG uptake between lesions of HL and DLBCL.\n\nOUTLINE:\n\nPatients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans 60 and 180 minutes after FDG administration.\n\nAfter completion of study, patients are followed for 24 hours.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with a pathologically-proven diagnosis of classic HL or DLBCL with measurable disease by any imaging technique or physical examination.\n\nExclusion Criteria:\n\n* Pregnant or nursing,\n* Uncontrolled diabetes mellitus,\n* Active infection,\n* Inability to give informed consent or to comply with all study procedures,\n* Subjects may be excluded at the discretion of the principal investigator or study team members.'}, 'identificationModule': {'nctId': 'NCT01004718', 'briefTitle': 'Detection and Quant of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using Positron Emission Tomography/Computed Tomography (PET/CT)', 'organization': {'class': 'OTHER', 'fullName': 'Abramson Cancer Center at Penn Medicine'}, 'officialTitle': 'A Pilot Study to Assess the Feasibility of Detection and Quantification of Differences in Hodgkin Lymphoma and Diffuse Large B-cell Lymphoma Using FDG-PET/CT Imaging', 'orgStudyIdInfo': {'id': 'UPCC 21408'}, 'secondaryIdInfos': [{'id': 'NCI-2009-01348'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fludeoxyglucose F18 (FDG) PET/CT scans', 'description': 'Patients undergo fludeoxyglucose F18 (FDG) positron emission tomography/computed tomography scans and 180 minutes after FDG administration.', 'interventionNames': ['Radiation: Fludeoxyglucose F18', 'Procedure: Computed Tomography', 'Procedure: Positron emission tomography']}], 'interventions': [{'name': 'Fludeoxyglucose F18', 'type': 'RADIATION', 'otherNames': ['18FDG, FDG, Fluorine-18, 2 Fluoro-2-deoxy-D-Glucose, Fludeoxyglucose F18'], 'description': 'Undergo FDG PET/CT scans', 'armGroupLabels': ['Fludeoxyglucose F18 (FDG) PET/CT scans']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['tomography, computed'], 'description': 'Undergo FDG PET/CT scans', 'armGroupLabels': ['Fludeoxyglucose F18 (FDG) PET/CT scans']}, {'name': 'Positron emission tomography', 'type': 'PROCEDURE', 'otherNames': ['FDG-PET, PET, PET scan, tomography, emission computed'], 'description': 'Undergo FDG PET/CT scans', 'armGroupLabels': ['Fludeoxyglucose F18 (FDG) PET/CT scans']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abramson Cancer Center of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abramson Cancer Center at Penn Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}