Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 1:11 AM
Study NCT ID:
NCT07417605
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-18
First Post:
2026-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077195', 'term': 'Squamous Cell Carcinoma of Head and Neck'}, {'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'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'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-11', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Parameters obtained using the Patlak Direct IDIF reconstruction method, Ki mean, Ki max, DV mean and DV max (standards) in FDG-PET LAFOV in the residual disease and post-treatment inflammation groups', 'timeFrame': '3 months post-curative radiotherapy', 'description': 'The reference test for the diagnosis of " residual diseases " and " post-radiation inflammation" will be based on the conclusion of the multidisciplinary team meeting ruling on the results of composite data, including clinical examination, pathological examination, morphological imaging (CT or MRI) and/or functional imaging (early evaluation PET).\n\nThe index test will be based on FDG-PET LAFOV whose parameters obtained using the Patlak Direct IDIF, Ki mean, Ki max, DV mean and DV max (standards) in the residual disease and post-therapy inflammation groups.'}], 'secondaryOutcomes': [{'measure': 'Standard Ki and DV parameters in LAFOV FDG-PET and anatomical pathology characteristics of tumours (p16 status, CPS, degree of tumour differentiation).', 'timeFrame': '3 months post-curative radiotherapy'}, {'measure': 'Dynamic (standard Ki and DV) and static (SUVmax, SUVmean, SUVpeak, MTV, TLG, textural features) parameters in LAFOV FDG-PET.', 'timeFrame': '3 months post-curative radiotherapy'}, {'measure': 'Ki and DV parameters in LAFOV FDG-PET and the occurrence of post-radiation toxicity', 'timeFrame': '3 months post-curative radiotherapy'}, {'measure': 'DV and Ki parameters derived from direct and indirect Patlak reconstructions with IDIF and/or PBIF.', 'timeFrame': '3 months post-curative radiotherapy'}, {'measure': 'Dates of imaging, dates of progression, dates of death and end of study dates', 'timeFrame': '12 months post TEP-FDG LAVOF imaging'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['4D dynamic analysis', 'post-radical inflammation', 'squamous cell carcinomas', 'FDG-PET LAFOV'], 'conditions': ['Head & Neck Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'This multicenter prospective observational study will evaluate the value of dynamic FDG-PET LAFOV imaging during the initial therapeutic assessment of a head and neck cancer 3 months after completion of curative radiotherapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients treated with radiotherapy for curative purposes for squamous cell carcinoma of the upper aerodigestive tract.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient ≥ 18 years of age\n* Presenting with head and neck squamous cell carcinoma\n* Completed curative treatment with external radiation therapy\n* Eligible for dynamic LAFOV FDG-PET scan for therapeutic evaluation at 3 months\n* Having given consent for the end-of-treatment consultation\n\nExclusion Criteria:\n\n* Hypersensitivity to 18F-FDG or other excipients contained in the contrast agent\n* Pregnancy or breastfeeding\n* History of treated upper gastrointestinal tract cancer\n* Other histology\n* Incomplete RTE treatment regimen\n* Refusal to participate'}, 'identificationModule': {'nctId': 'NCT07417605', 'acronym': 'POLARIS', 'briefTitle': 'Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Diagnostic Performance Of 4D Dynamic LAFOV FDG-PET Acquisition for Differentiation of Residual Disease and Post-radiation Inflammation in Head Neck SCC Treated by Radiotherapy.', 'orgStudyIdInfo': {'id': 'POLARIS - 29BRC24.0308'}}, 'contactsLocationsModule': {'locations': [{'zip': '29200', 'city': 'Brest', 'country': 'France', 'contacts': [{'name': 'Jean-Christophe Leclere, Dr', 'role': 'CONTACT', 'email': 'jean-christophe.leclere@chu-brest.fr', 'phone': '+33229020291'}], 'facility': 'CHU Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}], 'centralContacts': [{'name': 'Ronan ABGRAL, Pr', 'role': 'CONTACT', 'email': 'ronan.abgral@chu-brest.fr', 'phone': '+332 98 22 30 69'}, {'name': 'Jean-Christophe LECLERE, Dr', 'role': 'CONTACT', 'email': 'jean-christophe.leclere@chu-brest.fr', 'phone': '+332 98 22 02 91'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'Data will be available beginning two years and ending five years following the publication', 'ipdSharing': 'YES', 'description': 'All collected data that underlie results in a publication', 'accessCriteria': 'Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}