Ignite Creation Date:
2025-12-24 @ 2:35 PM
Ignite Modification Date:
2026-02-01 @ 5:08 PM
Study NCT ID:
NCT02279459
Status:
COMPLETED
Last Update Posted:
2020-08-06
First Post:
2014-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}], 'ancestors': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-04', 'studyFirstSubmitDate': '2014-10-28', 'studyFirstSubmitQcDate': '2014-10-28', 'lastUpdatePostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlate iodine quantification with the microvascular density in the biopsy specimen', 'timeFrame': 'up to 18 months'}], 'secondaryOutcomes': [{'measure': 'Utility of dual-energy computerized tomography obtained during chemoradiation therapy to predict treatment response.', 'timeFrame': 'up to 18 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to utilize dual-energy computed tomography (DECT) to investigate changes in tumor iodine concentration in patients with head and neck squamous cell carcinomas (HNSCC). Dual-energy computerized tomography could easily replace a standard CT neck with the added benefit of providing functional information that would only be possible with advanced computerized tomography perfusion, magnetic resonance diffusion (MRI) or positron emission tomography (PET) imaging techniques.', 'detailedDescription': 'Patients with head and/or neck tumors routinely have head and neck imaging completed with a computerized tomography scan, commonly called a CT scan. A CT scan combines a series of x-ray views that are taken from many different angles and uses computer processing to create cross-sectional images inside your body. These cross-sectional images are very thin slices, often less than 1 mm thick and allow the radiologist to examine parts of your tissue very closely.\n\nDual energy computed tomography (DECT) is a fairly new technology that uses both the normal x-ray and also a second less powerful x-ray to make the images. The Ottawa Hospital has scanners in use that are able to take the images that oncologists typically order for patients and can also be set to obtain DECT images at the same time.\n\nThe purpose of this study is to investigate whether DECT images can provide helpful information to better predict how the tumor will respond to treatment and the likely course of head and neck tumors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients, aged 18 years and older with untreated, histologically confirmed head and neck squamous cell carcinoma', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years and older\n* untreated, histologically confirmed head and neck squamous cell carcinoma\n\nExclusion Criteria:\n\n* paranasal sinus involvement of head and neck squamous cell carcinoma'}, 'identificationModule': {'nctId': 'NCT02279459', 'briefTitle': 'Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas', 'organization': {'class': 'OTHER', 'fullName': 'Ottawa Hospital Research Institute'}, 'officialTitle': 'Dual-Energy CT in Patients With Head and Neck Squamous Cell Carcinomas: Assessing Tumor Perfusion and Prediction of Treatment Outcomes', 'orgStudyIdInfo': {'id': '20140728-01H'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patient', 'description': 'Patients head and neck CT scans performed as standard of care done prior to radiation treatment and approximately 12 weeks following treatment, will be acquired in the dual-energy computed tomography (DECT) mode. Participants will have one additional scan, also in the DECT mode, 2 to 3 weeks after the start of their radiation treatment.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K1Y 4E9', 'city': 'Ottawa', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}], 'overallOfficials': [{'name': 'Santanu Chakraborty, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OHRI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ottawa Hospital Research Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'GE Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}