Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2025-12-25 @ 11:10 PM
Study NCT ID:
NCT00450567
Status:
COMPLETED
Last Update Posted:
2020-08-03
First Post:
2007-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'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'}, {'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-30', 'studyFirstSubmitDate': '2007-03-20', 'studyFirstSubmitQcDate': '2007-03-20', 'lastUpdatePostDateStruct': {'date': '2020-08-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2007-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of glucose metabolic response with progression-free survival, overall survival, and changes in tumor size as measured by fludeoxyglucose F 18 positron emission tomography/CT scan', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['recurrent non-small cell lung cancer', 'stage I non-small cell lung cancer', 'stage II non-small cell lung cancer', 'stage IIIA non-small cell lung cancer', 'stage IIIB non-small cell lung cancer', 'stage IV non-small cell lung cancer'], 'conditions': ['Lung Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Measuring changes in glucose metabolism in patients with cancer may help doctors predict how patients respond to treatment.\n\nPURPOSE: This clinical trial is studying glucose metabolism in patients with non-small cell lung cancer treated with targeted therapy and chemotherapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the prognostic significance of changes in glucose metabolism measured by fludeoxyglucose F 18 positron emission tomography (FDG-PET)/CT scan in patients with non-small cell lung cancer treated with targeted drugs comprising gefitinib, erlotinib hydrochloride, or other ErbB inhibitors, cyclooxygenase-2 inhibitors, or estrogen receptor blockers in combination with conventional chemotherapy.\n\nOUTLINE: This is a prospective study.\n\nPatients undergo fludeoxyglucose F 18 positron emission tomography (FDG-PET) scan and CT scan at baseline and at 2 weeks and 12 weeks after receiving targeted anticancer treatment. Metabolic changes detected by FDG-PET and size changes identified by CT scan are related to patient outcome and tumor response to treatment.\n\nPROJECTED ACCRUAL: A total of 120 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects diagnosed with non-small cell lung cancer (stage III B or stage IV) and will be treated with an experiemntal drug or a combination of chemotherapy and new drugs, as part of standarad of care or because of enrollment in a study protocol.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Histologically or cytologically confirmed non-small cell lung cancer\n* Any disease stage allowed\n* Undergoing targeted treatment\n\nExclusion Criteria:\n\nNone'}, 'identificationModule': {'nctId': 'NCT00450567', 'briefTitle': 'Glucose Metabolism in Patients With Non-Small Cell Lung Cancer Treated With Targeted Therapy and Chemotherapy', 'organization': {'class': 'OTHER', 'fullName': 'Jonsson Comprehensive Cancer Center'}, 'officialTitle': 'Monitoring Targeted Lung Cancer Treatments With FDG-PET/CT', 'orgStudyIdInfo': {'id': 'CDR0000423222'}, 'secondaryIdInfos': [{'id': 'P50CA086306', 'link': 'https://reporter.nih.gov/quickSearch/P50CA086306', 'type': 'NIH'}, {'id': 'UCLA-0410068-01'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'computed tomography', 'type': 'PROCEDURE'}, {'name': 'positron emission tomography', 'type': 'PROCEDURE'}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center at UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Johannes Czernin, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Jonsson Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jonsson Comprehensive Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}