Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 2:27 PM
Study NCT ID:
NCT04031534
Status:
UNKNOWN
Last Update Posted:
2020-07-30
First Post:
2019-07-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], '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': 'D009371', 'term': 'Neoplasms by Site'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-03-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2022-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-29', 'studyFirstSubmitDate': '2019-07-19', 'studyFirstSubmitQcDate': '2019-07-23', 'lastUpdatePostDateStruct': {'date': '2020-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Comparison of biodistribution of F-Miso PET scan in pre-therapeutic and sequences of MRI in patient with squamous cells carcinoma of oropharynx', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Correlation of F-Miso PET scan and Magnetic resonance imaging to measure hypoxia', 'timeFrame': '1 year'}, {'measure': 'Correlation between recurrence free survival at one year and rate of hypoxia determined by the 3 techniques (PET scan, MRI and IHC)', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['F-Miso PET scan', 'Magnetic resonance imaging', 'immunohistochemistry', 'Head and neck cancer'], 'conditions': ['Squamous Cell Carcinoma of the Oropharynx']}, 'descriptionModule': {'briefSummary': 'Hypoxia imaging has not been studied extensively by combining PET and MRI data. Few studies performed the double imaging and none associated anatomopathology with it . This study will use a rigorous methodology through the production of PET/MRI images at the same time by transferring the patient directly from PET to MRI. In addition, the population, unlike other studies, will include preoperative patients with 24-hour surgery for hypoxia imaging by obtaining additional data through specific immunohistochemical analysis of hypoxia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient with squamous cells carcinoma of oropharynx\n* Age Superior to 10 years old\n* Male or Female\n* measurable target according RECIST criteria\n\nExclusion Criteria:\n\n* -Other histologic cancer than squamous cells carcinoma of oropharynx\n* No measurable target\n* Presence of metastasis'}, 'identificationModule': {'nctId': 'NCT04031534', 'acronym': 'HYPONECK', 'briefTitle': 'Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Centre Henri Becquerel'}, 'officialTitle': 'Comparative Study of Hypoxia Measured in F-Miso PET/Scan and MRI in Patients With Squamous Cells Carcinoma : Correlation With Immunohistochemistry', 'orgStudyIdInfo': {'id': 'CHB16.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Measure of hypoxia by F-Miso PET scan and RMI', 'description': 'Patient will undergo F-Miso PET scan and MRI to detect hypoxia. Imaging will be correlated with immunohistochemistry on tumour biopsy', 'interventionNames': ['Drug: F-Miso PET scan coupled with MRI']}], 'interventions': [{'name': 'F-Miso PET scan coupled with MRI', 'type': 'DRUG', 'description': 'Patient will undergo F-Miso PET and MRI before surgery for their head and neck cancer. Hypoxia detect with imaging will be correlated with hypoxia detected by immunohistochemistry on tumour biopsy', 'armGroupLabels': ['Measure of hypoxia by F-Miso PET scan and RMI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76000', 'city': 'Rouen', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Sebastien Thureau, Md, PhD', 'role': 'CONTACT', 'email': 'sebastien.thureau@chb.unicancer.fr', 'phone': '+33232082992'}], 'facility': 'Centre Henri Becquerel', 'geoPoint': {'lat': 49.44313, 'lon': 1.09932}}], 'centralContacts': [{'name': 'Sebastien Thureau, MD, PhD', 'role': 'CONTACT', 'email': 'sebastien.thureau@chb.unicancer.fr', 'phone': '+33232082992'}, {'name': 'Doriane Richard, PhD', 'role': 'CONTACT', 'email': 'doriane.richard@chb.unicancer.fr', 'phone': '+33232082985'}], 'overallOfficials': [{'name': 'Sebastien Thureau, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Henri Becquerel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Henri Becquerel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}