Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-17 @ 5:36 AM
Study NCT ID:
NCT06555861
Status:
COMPLETED
Last Update Posted:
2024-08-15
First Post:
2024-08-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002289', 'term': 'Carcinoma, Non-Small-Cell Lung'}], 'ancestors': [{'id': 'D002283', 'term': 'Carcinoma, Bronchogenic'}, {'id': 'D001984', 'term': 'Bronchial Neoplasms'}, {'id': 'D008175', 'term': 'Lung Neoplasms'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D013899', 'term': 'Thoracic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-13', 'studyFirstSubmitDate': '2024-08-13', 'studyFirstSubmitQcDate': '2024-08-13', 'lastUpdatePostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Local Recurrence', 'timeFrame': 'Time-to-Event measures up to 5 years', 'description': 'accuracy'}], 'secondaryOutcomes': [{'measure': 'Cancer specific survival', 'timeFrame': 'Time-to-Event measures up to 5 years', 'description': 'accuracy'}, {'measure': 'Distant metastasis free survival', 'timeFrame': 'Time-to-Event measures up to 5 years', 'description': 'accuracy'}, {'measure': 'Recurrence free survival', 'timeFrame': 'Time-to-Event measures up to 5 years', 'description': 'accuracy'}, {'measure': 'Overall survival', 'timeFrame': 'Time-to-Event measures up to 5 years', 'description': 'accuracy'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'Radiomics', 'Early-stage NSCLC', 'Stereotactic radiotherapy'], 'conditions': ['Identify FDG PET/CT Parameters Predictive of Local Control']}, 'descriptionModule': {'briefSummary': 'The aim of this retrospective multicentric study was to develop and evaluate a prognostic FDG PET/CT radiomics signature in early-stage non-small cell lung cancer (NSCLC) patients treated with stereotactic radiotherapy (SBRT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Eighty-seven patients with NSCLC stage I-II and tumours diameters below 5 cm according to the 8th American Joint Committee on Cancer classification, treated with definitive curative SBRT from January 2012 to December 2016 at 4 French institutions (Rennes, Tours, Brest and Nantes) were retrospectively included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* NSCLC stage I-II treated by SBRT\n* PET/CT imaging performed within 60 days of SBRT\n\nExclusion Criteria:\n\n* Lack of follow-up\n* Refusal of consent'}, 'identificationModule': {'nctId': 'NCT06555861', 'acronym': 'MUMOFRAT retro', 'briefTitle': 'Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT) (Retros MUMOFRAT)', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Brest'}, 'officialTitle': 'Local Recurrence Prediction of by Texture Analysis Derived From Positron Emission Tomography (PET / CT) Imaging of Non-small Cell Lung Cancer (NSCLC) Treated With Stereotactic Radiotherapy (SBRT)', 'orgStudyIdInfo': {'id': '29BRC18.0283 - Retros MUMOFRAT'}}, 'contactsLocationsModule': {'locations': [{'zip': '44800', 'city': 'Nantes', 'state': 'Saint Herblain', 'country': 'France', 'facility': 'ICO', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '29609', 'city': 'Brest', 'country': 'France', 'facility': 'CHRU de Brest', 'geoPoint': {'lat': 48.39029, 'lon': -4.48628}}, {'zip': '35042', 'city': 'Rennes', 'country': 'France', 'facility': 'Centre Eugènes Marquis', 'geoPoint': {'lat': 48.11109, 'lon': -1.67431}}, {'zip': '37000', 'city': 'Tours', 'country': 'France', 'facility': 'CHU de Tours', 'geoPoint': {'lat': 47.39484, 'lon': 0.70398}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Brest', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}