Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-26 @ 2:07 AM
Study NCT ID:
NCT01123005
Status:
TERMINATED
Last Update Posted:
2017-11-06
First Post:
2009-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Imaging and Biomarkers of Hypoxia in Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C011700', 'term': 'carbogen'}, {'id': 'D003999', 'term': 'Dichloroacetic Acid'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D062845', 'term': 'Chloroacetates'}, {'id': 'D000085', 'term': 'Acetates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D006843', 'term': 'Hydrocarbons, Chlorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'whyStopped': 'Logistical', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2015-08-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-01', 'studyFirstSubmitDate': '2009-07-27', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2017-11-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-08-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-EF5 uptake (tumor: blood ratio) before and after carbogen breathing for a subset of subjects.', 'timeFrame': '1-5 days'}, {'measure': '18F-EF5 uptake (tumor: blood ratio) before and after administration of DCA for a subset of subjects.', 'timeFrame': '1-5 days'}], 'secondaryOutcomes': [{'measure': 'Levels of secreted hypoxia markers in plasma.', 'timeFrame': '1-5 days'}, {'measure': 'Hypoxia gene and protein expression scores in patients undergoing biopsy or surgical resection.', 'timeFrame': '1-5 days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neoplasms']}, 'descriptionModule': {'briefSummary': 'Hypoxia, meaning a lack of oxygen, has been associated strongly with a wide range of human cancers. Hypoxia occurs when tumor growth exceeds the ability of blood vessels to supply the tumor with oxygenated blood. It is currently understood that hypoxic tumors are more aggressive. Current methods for measuring hypoxia include invasive procedures such as tissue biopsy, or insertion of an electrode into the tumor. EF5-PET may be a non-invasive way to measure tumor hypoxia.', 'detailedDescription': 'To establish PET imaging with the tracer EF5 as an accurate and reliable method for measuring the oxygen content of a tumor and to establish the measurement of secreted markers in blood as an accurate and reliable method for measuring the oxygen content of a tumor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'INCLUSION CRITERIA\n\n* Any solid tumor malignancies of any stage meeting all of the following criteria: Minimum tumor dimension is at least 1 cm (to ensure it is above the detection threshold of PET imaging). Examples include but are not limited to: locally advanced squamous cell carcinoma of the head and neck to be treated by either initial surgery or primary chemoradiotherapy; inoperable non-small cell lung cancer or pancreatic carcinoma to be treated with stereotactic radiotherapy, which may be biopsied again at the time of percutaneous needle delivery of implanted fiducial markers.\n* Patients with newly diagnosed malignancies should not have initiated treatment for their disease before participating in this study. Patients with recurrent or second malignancies may have had prior therapy as appropriate for their disease, but should have completed all prior treatment at least 30 days before participation in this study and should not have initiated new treatment for the current problem.\n* Greater than or equal to eighteen years of age.\n* Sufficiently healthy to tolerate all study procedures.\n* Organ and marrow function sufficient to undergo planned therapy.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nEXCLUSION CRITERIA\n\n• Pregnant or nursing'}, 'identificationModule': {'nctId': 'NCT01123005', 'briefTitle': 'Imaging and Biomarkers of Hypoxia in Solid Tumors', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Imaging and Biomarkers of Hypoxia in Solid Tumors', 'orgStudyIdInfo': {'id': 'IRB-15039'}, 'secondaryIdInfos': [{'id': 'VAR0032', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Carbogen arm', 'interventionNames': ['Procedure: PET Scan', 'Drug: EF5', 'Drug: Carbogen']}, {'type': 'EXPERIMENTAL', 'label': 'DCA arm', 'interventionNames': ['Procedure: PET Scan', 'Drug: EF5', 'Drug: Dichloroacetate']}], 'interventions': [{'name': 'PET Scan', 'type': 'PROCEDURE', 'otherNames': ['positron emission tomography'], 'description': 'radiation calculated per patient', 'armGroupLabels': ['Carbogen arm', 'DCA arm']}, {'name': 'EF5', 'type': 'DRUG', 'otherNames': ['NSC-684681'], 'description': '10 mCi, IV', 'armGroupLabels': ['Carbogen arm', 'DCA arm']}, {'name': 'Carbogen', 'type': 'DRUG', 'otherNames': ["Meduna's Mixture"], 'description': 'Calculated per patient', 'armGroupLabels': ['Carbogen arm']}, {'name': 'Dichloroacetate', 'type': 'DRUG', 'otherNames': ['DCA'], 'armGroupLabels': ['DCA arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'Dr. Billy W. Loo Jr. M.D. Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Radiation Oncology', 'investigatorFullName': 'Billy W. Loo Jr.', 'investigatorAffiliation': 'Stanford University'}}}}