Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-25 @ 11:09 PM
Study NCT ID:
NCT01359267
Status:
COMPLETED
Last Update Posted:
2020-05-08
First Post:
2011-05-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C522236', 'term': 'technetium 99m ethylenedicysteine deoxyglucose'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-04-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2011-05-20', 'studyFirstSubmitQcDate': '2011-05-23', 'lastUpdatePostDateStruct': {'date': '2020-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-05-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Persistent Disease within 6 months of CRT', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Persistent Disease within 2 years of CRT', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to obtain preliminary information on the potential of 99m Tc-EC-DG SPECT imaging to distinguish cancer from non cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Treatment naive patients with histologically proven cancer of the head and neck\n* T4 primary tumor (all sites), N2 or N3 locoregional disease (all sites)\n* At least one measurable site of disease\n* At least 18 years of age\n* Karnofsky performance status \\> or = 70% or ECOG \\<2\n* Able to tolerate SPECT/CT imaging\n* Adequate bone marrow function\n* Adequate liver function\n* Adequate renal function\n* Written consent from patients\n* Female patients of childbearing potential must have a negative pregnancy test within 0-7 days prior to the first SPECT study\n\nExclusion Criteria:\n\n* Diabetics with insulin dependence or blood sugar levels \\>200 mg/dL prior to imaging\n* Patient weight above the SPECT/CT table weight limit\n* Pregnant and/or lactating female\n* Unequivocal demonstration of metastatic disease\n* Patients unwilling to or unable to comply with protocol'}, 'identificationModule': {'nctId': 'NCT01359267', 'briefTitle': 'Feasibility of Imaging in the Treatment of Patients With Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Chicago'}, 'officialTitle': 'A Pilot Feasibility Study of 99mTc EC DG SPECT/CT Imaging in the Treatment Response Evaluation in Patients With Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': '11-0032'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imaging', 'interventionNames': ['Drug: 99mTc-EC-DG']}], 'interventions': [{'name': '99mTc-EC-DG', 'type': 'DRUG', 'description': '99mTc-EC-DG will be used before the SPECT/CT scans throughout the study to determine the its effectiveness. 20 mCi of 99mtc-EC-DG will be administered through a vein through a catheter. This will be done before the SPECT/CT scan at 4 weeks and 10 weeks.', 'armGroupLabels': ['Imaging']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Everett Vokes, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Chicago'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Chicago', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}