Ignite Creation Date:
2025-12-24 @ 5:31 PM
Ignite Modification Date:
2026-02-26 @ 4:31 PM
Study NCT ID:
NCT03038568
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2017-01-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing How Normal Variations in CT Scanning Affects Its Interpretation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Canada']}, 'interventionBrowseModule': {'meshes': [{'id': 'D014057', 'term': 'Tomography, X-Ray Computed'}], 'ancestors': [{'id': 'D007090', 'term': 'Image Interpretation, Computer-Assisted'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011856', 'term': 'Radiographic Image Enhancement'}, {'id': 'D007089', 'term': 'Image Enhancement'}, {'id': 'D010781', 'term': 'Photography'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D014056', 'term': 'Tomography, X-Ray'}, {'id': 'D014054', 'term': 'Tomography'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-22', 'size': 540964, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-04-14T11:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 169}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-17', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-01-30', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-01-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans', 'timeFrame': '2 years', 'description': 'There will be 18 cohorts, each cohort differing by the length of the time gap in acquisition and noise index. In addition each acquisition will be reconstructed in 21 different ways (combinations of 3 slice thicknesses and 7 ASiR levels).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['colorectal liver metastases', 'CT scan', '17-010'], 'conditions': ['Colorectal Cancer Metastatic']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to see how measurements of tumor differences vary with slight changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even in the setting of variable scan parameters and variable contrast timing. Participants will be consented to undergo an additional CT of their abdomen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who undergo contrast enhanced CT scanning for colorectal liver metastases will be consented for one additional CT abdomen phase during the same imaging session.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients ≥ 18 years of age on the day of signed informed consent\n* Patients scheduled and approved for contrast enhanced CT that includes imaging of the abdomen and pelvis following the Department of Radiology standard of care protocol as per local institutional guidelines\n* Patients with measurable colorectal liver metastases on prior imaging, with at least one tumor greater than 2.0 cm in axial maximal diameter\n\nExclusion Criteria:\n\n* Patient who is pregnant and/or lactating\n* Patient scheduled for CT that includes the abdomen with a multiphasic contrast enhanced protocol (e.g. Triple Phase or Quadruple Phase Liver CT)\n* Patient who require reduced intravenous contrast dose based on the Department of Radiology contrast policy as per local institutional guidelines\n* Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or follow up procedures"}, 'identificationModule': {'nctId': 'NCT03038568', 'briefTitle': 'Assessing How Normal Variations in CT Scanning Affects Its Interpretation', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Stability of Radiomic Features for Abdominal Tumors on Contrast Enhanced CT', 'orgStudyIdInfo': {'id': '17-010'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cohort 1', 'description': '-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 2', 'description': '-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 3', 'description': '-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 4', 'description': '-10 second time gap between routine abdominal CT and add on CT, Noise index 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 5', 'description': '-10 second time gap between routine abdominal CT and add on CT, Noise index 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 6', 'description': '-10 second time gap between routine abdominal CT and add on CT, Noise index 16', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 7', 'description': '\\- 5 second time gap between routine abdominal CT and add on CT, Noise index 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 8', 'description': '\\- 5 second time gap between routine abdominal CT and add on CT, Noise index 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 9', 'description': '\\- 5 second time gap between routine abdominal CT and add on CT, Noise index 16', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 10', 'description': '\\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 11', 'description': '\\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 12', 'description': '\\+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 13', 'description': '\\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 14', 'description': '\\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 15', 'description': '\\+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 16', 'description': '\\+ 15 second time gap between routine abdominal CT and add on CT, Noise 12', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 17', 'description': '\\+ 15 second time gap between routine abdominal CT and add on CT, Noise 14', 'interventionNames': ['Diagnostic Test: CT scan']}, {'label': 'Cohort 18', 'description': '\\+ 15 second time gap between routine abdominal CT and add on CT, Noise 16', 'interventionNames': ['Diagnostic Test: CT scan']}], 'interventions': [{'name': 'CT scan', 'type': 'DIAGNOSTIC_TEST', 'description': 'Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.', 'armGroupLabels': ['Cohort 1', 'Cohort 10', 'Cohort 11', 'Cohort 12', 'Cohort 13', 'Cohort 14', 'Cohort 15', 'Cohort 16', 'Cohort 17', 'Cohort 18', 'Cohort 2', 'Cohort 3', 'Cohort 4', 'Cohort 5', 'Cohort 6', 'Cohort 7', 'Cohort 8', 'Cohort 9']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center, Texas (Data collection only)', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Kinh Gian Richard Do, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Kingston Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}