Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT01823094
Status:
COMPLETED
Last Update Posted:
2016-01-26
First Post:
2013-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CTP Imaging of Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-22', 'studyFirstSubmitDate': '2013-03-22', 'studyFirstSubmitQcDate': '2013-03-28', 'lastUpdatePostDateStruct': {'date': '2016-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-04-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Yield of conducting CTP studies', 'timeFrame': '2 years', 'description': 'Yield is determined as the percentage of assessable CTP studies, relative to all performed studies'}], 'secondaryOutcomes': [{'measure': 'Variability of CTP measurements', 'timeFrame': '2 years', 'description': 'Variability will be determined from two consecutively acquired CTP examinations, and repeated analyses of the same studies'}, {'measure': 'Magnitude of treatment induced changes in tumor blood flow', 'timeFrame': '2 years', 'description': 'The magnitude of treatment induced changes in blood flow will be determined from comparisons of bloodflow before and after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['lung cancer', 'computed tomography', 'blood flow'], 'conditions': ['Non Small Cell Lung Cancer']}, 'descriptionModule': {'briefSummary': 'Investigators hope to learn more about how to use computed tomography (CT) scans to measure blood flow in lung tumors and how it may change in response to treatment. This measurement technique is called computed tomography perfusion (CTP). CT scanners use X-rays to produce 3-dimensional images of the body.\n\nCurrently, doctors determine the response to treatment by measuring the size of the tumor. Investigators are trying to find out if measuring the blood flow in the tumor is equal to or better than measuring the size of the tumor.', 'detailedDescription': 'This is an experimental study of CT perfusion (CTP) imaging in subjects with non-small cell lung cancer. The objectives of this study are to demonstrate the feasibility of CT blood flow measurements in lung cancer, to develop a foundation for the use of CT blood flow measurements in lung cancer to assess the response to treatment, and to develop an optimized CTP imaging protocol for evaluating blood flow in solid body tumors. In this study, tumor blood flow will be evaluated at baseline and follow-up routine CT examinations of patients with non-small cell lung cancer, and the response of tumor blood flow will be recorded as a secondary endpoint. This research study will entail two study visits - one required and one optional - which will coincide with regularly scheduled standard of care CT scans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients with non small cell lung cancer who are planned to receive systemic therapy', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nadult patients with non small cell lung cancer who receive, or are considered for, systemic therapy\n\nExclusion Criteria:\n\nrenal failure pregnancy known contrast allergy\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01823094', 'acronym': 'CTPLC', 'briefTitle': 'CTP Imaging of Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'CTP (Computed Tomography Perfusion) Imaging of Lung Cancer', 'orgStudyIdInfo': {'id': '393991'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Variability of measurements', 'description': 'variability of CTP measurements will be determined by repeating the CTP examination, and comparing the resultant blood flow estimates'}, {'label': 'Treatment induced effects', 'description': 'The magnitude of treatment induced effects will be assessed by comparing tumor blood flow estimates before and after treatment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'overallOfficials': [{'name': 'Friedrich Knollmann, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Univeristy of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'collaborators': [{'name': 'Radiological Society of North America', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}