Ignite Creation Date:
2025-12-24 @ 4:45 PM
Ignite Modification Date:
2025-12-27 @ 4:10 AM
Study NCT ID:
NCT00896350
Status:
TERMINATED
Last Update Posted:
2019-02-18
First Post:
2009-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2009-05-08', 'studyFirstSubmitQcDate': '2009-05-08', 'lastUpdatePostDateStruct': {'date': '2019-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2009-05-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MRI signal sensitivity to oxygen', 'timeFrame': '12 weeks', 'description': 'MRI signal sensitivity to oxygen breathing and delayed contrast-enhancement (DCE)'}, {'measure': 'Tumor shrinkage and blood oxygen association', 'timeFrame': '12 weeks', 'description': 'Association between tumor shrinkage and blood oxygen level dependent'}], 'secondaryOutcomes': [{'measure': 'Correlate tumor hypoxia with patient prognosis and treatment response', 'timeFrame': '12 weeks', 'description': 'Association between tumor hypoxia, patient prognosis, and treatment response.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Diagnostic procedures, such as functional MRI, may help measure oxygen levels in tumor cells and may help in planning cancer treatment.\n\nPURPOSE: This phase I trial is studying functional MRI to see how well it works in finding hypoxia in patients undergoing chemotherapy and radiation therapy for stage III or stage IV head and neck cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the undertaken oxygen sensitive MRI for the detection of hypoxia in patients with Stage III-IV head and neck cancer.\n* Correlate MRI parameters with histology, gene expression, and plasma osteopontin.\n* Correlate tumor hypoxia measurements with patient prognosis and treatment response.\n\nOUTLINE:\n\n* Pre-therapy MRI: Patients undergo blood oxygen level dependant (BOLD) contrast MRI on room air breathing over 2 minutes and with oxygen gas over 15 minutes. Patients also undergo MR-spectroscopy over 15 minutes to measure choline and lactate markers, and dynamic contrast MRI with gadolinium contrast over 8 minutes.\n* Chemoradiotherapy: Patients receive platinum based chemotherapy every two weeks. Patients also undergo radiation therapy for 6 weeks.\n* Post-radiation MRI: Patients undergo MRI as before chemoradiotherapy. Blood and tumor samples are collected at baseline for biomarker analysis associated with tumor progression or response.\n\nAfter completion of study, patients are followed every 3 months for up to 1 year.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed squamous cell carcinoma of the head and neck\n\n * Stage III or IV disease\n* Measurable disease\n* Scheduled to undergo standard treatment including radiation therapy and chemotherapy\n* Participation on study # 092004-010 for tissue procurement\n\nPATIENT CHARACTERISTICS:\n\n* ECOG performance status 0-2\n* Serum creatinine ≤ 1.5 OR creatinine clearance ≥ 40\n* Body mass index ≤ 34 Kg/m\\^2\n* Not claustrophobic\n* No other contraindications to MRI (i.e., implanted pacemaker device)\n* Not pregnant or nursing\n* Negative pregnancy test\n* No allergy to gadolinium\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00896350', 'briefTitle': 'MRI in Finding Hypoxia in Patients Undergoing Chemo and Radiation for Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Predicting Treatment Response Based on Hypoxia in Head and Neck Cancers Using Non-Invasive Oxygen Sensitive MRI', 'orgStudyIdInfo': {'id': 'SCCC-02308'}, 'secondaryIdInfos': [{'id': 'CDR0000637640', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'NCI-2011-02811', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trials Reporting System)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BOLD MRI', 'description': 'Determine the amount of oxygen supply to tumors.', 'interventionNames': ['Drug: Standard Care Chemoradiation']}], 'interventions': [{'name': 'Standard Care Chemoradiation', 'type': 'DRUG', 'description': 'External beam radiation to the neck and tumor site of head and neck. Concurrent platinum based chemotherapy. External beam "boost" at discretion of treating physician.', 'armGroupLabels': ['BOLD MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Baran Sumer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Simmons Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}