Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-04-18 @ 2:52 AM
Study NCT ID:
NCT01789892
Status:
WITHDRAWN
Last Update Posted:
2018-06-28
First Post:
2013-02-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008175', 'term': 'Lung Neoplasms'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008775', 'term': 'Methylprednisolone'}, {'id': 'D000077555', 'term': 'Methylprednisolone Acetate'}, {'id': 'D008776', 'term': 'Methylprednisolone Hemisuccinate'}, {'id': 'D019788', 'term': 'Fluorodeoxyglucose F18'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}], 'ancestors': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003847', 'term': 'Deoxyglucose'}, {'id': 'D003837', 'term': 'Deoxy Sugars'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'SINGLE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'no patient accrual', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-26', 'studyFirstSubmitDate': '2013-02-08', 'studyFirstSubmitQcDate': '2013-02-08', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Continuous standardized uptake values (SUV)', 'timeFrame': 'Within 1-14 days of first scan', 'description': 'The SUV on the first and second PET scans will be recorded and summarized on a receiver operating characteristic (ROC) curve. We will explore the ROC curve for percent change in SUV or uptake ratio from the first to the second scan. We will explore thresholds for SUV and uptake values on the ROC curve by determining the values of acceptable combinations of true positive fractions (TPF) and false positive fractions (FPFs). We will use regression methods to adjust for possible confounding patient demographics, disease severity and disease history.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Lung Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://cancer.osu.edu', 'label': 'Jamesline'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether giving an anti-inflammatory medication (corticosteroid) prior to a positron emission tomography scan (PET) scan may reduce or eliminate false findings related to inflammation', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To assess whether premedication with a corticosteroid may reduce false positive findings on fluorodeoxyglucose (fludeoxyglucose F 18 \\[FDG\\[) PET/computed tomography (CT) scans in lung cancer patients, by reducing radiotracer uptake in thoracic lymph nodes related to inflammation.\n\nOUTLINE:\n\nWithin 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone intravenously (IV) and then undergo a second FDG PET/CT scan.\n\nAfter completion of study treatment, patients are followed up for 2 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient undergoing initial staging of biopsy proven lung cancer (all cancer stages included)\n* Undergone clinical FDG PET/CT scan within 14 days of enrollment\n\nExclusion Criteria:\n\n* Prisoners\n* Diabetic patients (on insulin, on oral hypoglycemic, or fasting glucose \\> 180 mg/dl)\n* Serious infection within 14 days of enrollment\n* Known hypersensitivity to methylprednisolone\n* Viral skin lesions\n* Immunocompromised ANC(absolute neutrophil count \\< 1000/microliter)\n* Pregnant/nursing\n* History of tuberculosis or systemic fungal disease\n* History of steroid psychosis\n* Current peptic ulcer disease or diverticulitis\n* Corticosteroid use within 14 days of enrollment (including inhaled steroids)'}, 'identificationModule': {'nctId': 'NCT01789892', 'briefTitle': 'Methylprednisolone Before Fludeoxyglucose-Labeled Positron Emission Tomography in Patients With Lung Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Ohio State University Comprehensive Cancer Center'}, 'officialTitle': 'FDG PET/CT: Reducing False Positive Mediastinal Uptake by Premedicating With Methylprednisolone', 'orgStudyIdInfo': {'id': 'OSU-10012'}, 'secondaryIdInfos': [{'id': 'NCI-2012-00530', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (methylprednisolone and FDG PET/CT scan)', 'description': 'Within 1-14 days of undergoing standard FDG PET/CT scan, patients receive methylprednisolone IV and then undergo a second FDG PET/CT scan.', 'interventionNames': ['Drug: methylprednisolone', 'Radiation: fludeoxyglucose F 18', 'Procedure: positron emission tomography', 'Procedure: computed tomography']}], 'interventions': [{'name': 'methylprednisolone', 'type': 'DRUG', 'otherNames': ['Depo-Medrol', 'Medrol', 'MePRDL', 'Solu-Medrol', 'Wyacort'], 'description': 'Given IV', 'armGroupLabels': ['Diagnostic (methylprednisolone and FDG PET/CT scan)']}, {'name': 'fludeoxyglucose F 18', 'type': 'RADIATION', 'otherNames': ['18FDG', 'FDG'], 'description': 'Undergo FDG PET/CT scan', 'armGroupLabels': ['Diagnostic (methylprednisolone and FDG PET/CT scan)']}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'otherNames': ['FDG-PET', 'PET', 'PET scan', 'tomography, emission computed'], 'description': 'Undergo FDG PET/CT scan', 'armGroupLabels': ['Diagnostic (methylprednisolone and FDG PET/CT scan)']}, {'name': 'computed tomography', 'type': 'PROCEDURE', 'otherNames': ['tomography, computed'], 'description': 'Undergo FDG PET/CT scan', 'armGroupLabels': ['Diagnostic (methylprednisolone and FDG PET/CT scan)']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'David Barker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ohio State University Comprehensive Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ohio State University Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}