Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2025-12-26 @ 3:00 PM
Study NCT ID:
NCT04654156
Status:
COMPLETED
Last Update Posted:
2020-12-04
First Post:
2020-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011655', 'term': 'Pulmonary Embolism'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D004617', 'term': 'Embolism'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-29', 'studyFirstSubmitDate': '2020-10-06', 'studyFirstSubmitQcDate': '2020-11-29', 'lastUpdatePostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of thrombi within each branch of the pulmonary arteries', 'timeFrame': 'Between March and June 2018', 'description': 'The pulmonary arteries were divided into 11 zones according to their anatomical characteristics then each visible thrombus was reported in a Excel table according to the zone where it was located'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary embolism'], 'conditions': ['Pulmonary Embolism']}, 'descriptionModule': {'briefSummary': 'Pulmonary embolism is a common cardiovascular disease and thoracic CT angiography is currently considered the gold standard for its non-invasive diagnosis. However, the diagnostic performance of CT angiography can be hampered by an insufficient enhancement of pulmonary arteries. Contrast Enhancement Boost (CE Boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement.\n\nThis retrospective study compares standard CT-angiography images with CE Boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patient referred in our institution by emergency practitioners who underwent thoracic CT angiography for clinical suspicion of pulmonary embolism between March and June 2018', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient who underwent thoracic CT angiography for suspicion of pulmonary embolism in our institution between March and June 2018\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04654156', 'briefTitle': 'Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Assessment of Contrast Enhancement Boost for the Direct Identification of Pulmonary Emboli in Thoracic CT Angiography', 'orgStudyIdInfo': {'id': '2020PI216'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Pathological group', 'description': 'Patients with pulmonary embolism on thoracic CT angiography', 'interventionNames': ['Diagnostic Test: Contrast Boost post processing technique']}, {'label': 'Healthy group', 'description': 'Patients without pulmonary embolism on thoracic CT angiography', 'interventionNames': ['Diagnostic Test: Contrast Boost post processing technique']}], 'interventions': [{'name': 'Contrast Boost post processing technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Contrast Enhancement Boost is a post-processing technique that uses an iodine density map generated by subtracting a pre- and post-contrast CT acquisition to artificially enhance pulmonary artery enhancement.', 'armGroupLabels': ['Healthy group', 'Pathological group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Nancy', 'state': 'Meurthe-et-Moselle', 'country': 'France', 'facility': 'CHRU Nancy', 'geoPoint': {'lat': 48.68439, 'lon': 6.18496}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pedro TEIXEIRA-GONDIM, MD', 'investigatorAffiliation': 'Central Hospital, Nancy, France'}}}}