Ignite Creation Date:
2025-12-24 @ 2:06 PM
Ignite Modification Date:
2026-02-20 @ 4:32 PM
Study NCT ID:
NCT03160495
Status:
COMPLETED
Last Update Posted:
2019-03-26
First Post:
2017-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens
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': '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'The gross specimen will be examined, sectioned and placed in tissue cassettes as done in routine. Six tissue blocks will be picked for microscopic evaluation and IHC staining. The specific selection of cancer related IHC biomarkers is based on their relationship with tumor cell metabolism, radiotherapy resistance (proliferation and hypoxia), association with FDG accumulation and institutional experience from a previous study'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2018-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-25', 'studyFirstSubmitDate': '2017-05-16', 'studyFirstSubmitQcDate': '2017-05-17', 'lastUpdatePostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantified measures from FDG PET and pathology', 'timeFrame': '3-6 months', 'description': 'Correlation between FDG uptake (measured as SUV) and expression of IHC biomarkers'}, {'measure': 'Quantified measures from DWI and pathology', 'timeFrame': '3-6 months', 'description': 'Correlation between diffusion weighted imaging and expression of IHC biomarkers'}, {'measure': 'Quantified measures from DCE and pathology', 'timeFrame': '3-6 months', 'description': 'Correlation between dynamic contrast enhancement and expression of IHC biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/MR', 'Squamous cell carcinoma', 'Heterogeneity'], 'conditions': ['Squamous Cell Carcinoma of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate if heterogeneity in head and neck squamous cell carcinoma as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.', 'detailedDescription': 'The following is a presentation of a prospective protocol, named FIGHHT, including patients with squamous cell carcinoma of the head and neck (HNSCC) who are referred for surgery.\n\nThis is a prospective imaging/biomarker expression study where patients referred for surgery for HNSCC will be included. The purpose of the study is to investigate if heterogeneity in HNSCC as seen in functional imaging with PET/MR can be correlated to biologic heterogeneity in surgical specimens.\n\nMultiparametric imaging(MPI) is performed before surgery using a PET/MR system (Siemens Biograph mMR) with a 3 T magnet using a head and neck coil. The scan protocol includes diffusion weighted MRI, dynamic contrast enhanced perfusion MRI and FDG-PET (4 MBq/kg). Morphometric imaging is performed with a 3D T2 weighted sequence (SPACE, voxel size 1.0 mm isotropic in vivo and 0.5 mm isotropic for specimens).\n\nThe scans are evaluated by a radiologist and a specialist in nuclear medicine and regions of interest and reference areas (anatomical landmarks) are marked. The tumor and if indicated lymp nodes are removed en bloc and per-operatively the reference areas and other anatomical landmarks are marked in the specimen with intravenous tubes. The specimen is fixed to a corkboard and scanned morphometric (as described) using a knee coil before and after formalin fixation within 1 hour after surgery. The whole surgical specimen is sectioned for histological processing.\n\nTissue blocks will undergo microscopic pathological evaluation and IHC staining. The specific selection of cancer related IHC biomarkers is based on their relationship with tumor cell metabolism, radiotherapy resistance (proliferation and hypoxia), association with FDG accumulation and institutional experience from a previous study.\n\nThe quantified measurements from the FDG PET, DWI and DCE scan will be correlated to the expression of IHC biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Please see detailed description', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Informed consent\n* Age above 18\n* Primary or recurrent squamous cell carcinoma in the head and neck area\n* Referred to surgery\n* Primary tumor \\> 1.5 cm and or neck metastasis of more than 1 cm.\n\nExclusion Criteria:\n\n* Patient refusal\n* Contraindications for FDG-PET/MR scan\n\n * Pacemaker\n * Severe claustrophobia\n * Magnetic metal in the body that is not MR compatible'}, 'identificationModule': {'nctId': 'NCT03160495', 'acronym': 'FIGHHT', 'briefTitle': 'Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Functional ImaGing of Heterogeneity in Head and Neck Tumors - Validation From Surgical Specimens', 'orgStudyIdInfo': {'id': 'H-16049387'}}, 'armsInterventionsModule': {'interventions': [{'name': 'All patients', 'type': 'OTHER', 'description': 'All patients are scanned with PET/MR prior to surgery.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Department of Otorhinolaryngology, Head & Neck Surgery and Audiology Rigshospitalet, University of Copenhagen', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Jacob Rasmussen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}