Ignite Creation Date:
2025-12-24 @ 11:49 PM
Ignite Modification Date:
2025-12-25 @ 9:43 PM
Study NCT ID:
NCT00582751
Status:
COMPLETED
Last Update Posted:
2010-11-02
First Post:
2007-12-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Volumetric Analysis in the Assessment of Therapy Response by CT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-11', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-11-01', 'studyFirstSubmitDate': '2007-12-21', 'studyFirstSubmitQcDate': '2007-12-21', 'lastUpdatePostDateStruct': {'date': '2010-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To compare volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.', 'timeFrame': '1 year'}]}, 'conditionsModule': {'keywords': ['Volumetric Analysis', 'Multiple Diseases'], 'conditions': ['Multiple Diseases']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org', 'label': 'Memorial Sloan-Kettering Web Site'}]}, 'descriptionModule': {'briefSummary': 'To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.', 'detailedDescription': 'To compare the volumetric response achieved using semi-automated computer techniques with the uni-dimensional (RECIST) and bi-dimensional (WHO) criteria as part of clinical trials running at MSKCC, testing new agents for different types of solid tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '90 patients from 3 different sections will be accrued (30 liver lesions, 30 lung lesions, 30 lymph node lesions).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Registered and being treated on one of the following therapeutic protocols:\n\n06-043, 07-052, 07-057, 07-112, 07-116, 08-093, and 08-054\n\n* Have at least one measurable lesion\\* as per RECIST criteria situated in lung, liver or lymph node meeting RECIST criteria noted on a baseline CT scan.\n* Baseline\\*\\* and at least one follow-up CT scan to likely to be obtained at an MSKCC facility\n* All patients must be \\> or = to 18 years old\n\n * The measurable lesions are metastatic in the liver, lung and lymph nodes. The algorithms do not distinguish between primary and metastatic disease, therefore, in selected cases, a primary lesion such as in the liver or lung may also be assessed.\n\n * Baseline CT are prefer but if not able to obtain for volumetric reconstructions follow up studies will still be use for other objectives if the study.\n\nExclusion Criteria:\n\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT00582751', 'briefTitle': 'Volumetric Analysis in the Assessment of Therapy Response by CT', 'nctIdAliases': ['NCT00577291'], 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Volumetric Analysis in the Assessment of Therapy Response by CT', 'orgStudyIdInfo': {'id': '07-141'}}, '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}}], 'overallOfficials': [{'name': 'Robert Lefkowitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Robert Lefkowitz, MD', 'oldOrganization': 'Memorial Sloan-Kettering Cancer Center'}}}}