Ignite Creation Date:
2025-12-24 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
Study NCT ID:
NCT05800132
Status:
RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-03-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-11', 'studyFirstSubmitDate': '2023-03-23', 'studyFirstSubmitQcDate': '2023-03-23', 'lastUpdatePostDateStruct': {'date': '2024-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recall rate', 'timeFrame': 'End of the inclusion period 24 months', 'description': 'Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.'}], 'secondaryOutcomes': [{'measure': 'Cancer detection rate', 'timeFrame': 'End of the inclusion period 24 months', 'description': 'Number of biopsy proven cancers divided by the total number of patient receiving a second reading'}, {'measure': 'Sensitivity and Specificity', 'timeFrame': 'End of the follow_up period 48 months', 'description': 'True and false-positive rate'}, {'measure': 'Economic impact', 'timeFrame': 'End of the follow_up period 48 months', 'description': 'Difference in direct medical costs between the two arms Difference in annual budgetary impact on the French National Health Insurance between the two arms'}, {'measure': 'Time-to-results', 'timeFrame': 'End of the inclusion period 24 months', 'description': 'Time period \\[in days\\] between the day of the screening and the access to results'}, {'measure': 'Reading time', 'timeFrame': 'End of the inclusion period 24 months', 'description': 'Time needed \\[in seconds\\] to interpret a mammogram'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['artificial intelligence', 'breast cancer screening', 'second reading'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to compare, for the second reading of screening mammograms, the standard of care with an AI assisted scenario.\n\nThe main questions it aims to answer are:\n\n* will the experimental pathway be non-inferior to the standard pathway?\n* will the experimental pathway be economically superior to the standard pathway?\n\nParticipants will receive screening mammograms, as part of the breast cancer screening program. Researchers will compare the interpretation made by the second reader in the standard pathway with the AI assisted interpretation made by a different reader in the experimental pathway.', 'detailedDescription': "All mammograms eligible for a second reading, and included in the study, go through 2 arms:\n\n* Conventional second reading by a radiologist accredited to do second reading in France (L2 control arm),\n* Second reading assisted by the AI (L2-AI experimental arm): mammograms will be read by the AI first and only if deemed suspicious, a radiologist accredited to do second reading in France will review them.\n\nThe most pejorative assessment among the two arms is used as the final decision: if both arms consider the mammogram as negative, the participant won't be recalled, if one arm consider the mammogram as positive, the participant will be called back for further examinations.\n\nClinical performances and economical impacts of both scenarii will be compared."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '74 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Affiliated to the French social security system\n* Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,\n* Whose mammograms have been determined to be normal or to have benign lesions by the radiologist who performed the first reading of the images (L1) in the framework of the organized breast cancer screening program\n* Having expressed her willingness to participate in the study, to undergo all the procedures and to make herself available for the expected duration of their participation,\n* Having completed and signed the informed consent form.\n\nExclusion Criteria:\n\n* Woman with breast implants,\n* With clinical symptoms of breast cancer,\n* With a history of breast surgery (breast reduction or surgery for benign lesion),\n* Pregnant or breastfeeding,\n* With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,\n* Deprived of liberty by judicial or administrative order,\n* Participant whose mammogram images have at least one of the following defects: poor quality of the images, non-standard mammography (projection, magnification, compression), ML/LM/SIO/XCCL or XCCM view.'}, 'identificationModule': {'nctId': 'NCT05800132', 'acronym': 'IMA-L2', 'briefTitle': 'Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI', 'organization': {'class': 'INDUSTRY', 'fullName': 'Therapixel'}, 'officialTitle': "Évaluation de la Performance Diagnostique du dépistage du Cancer du Sein, Pour Une Seconde Lecture Des clichés de Mammographie assistée du Dispositif médical à Base d'Intelligence Artificielle MammoScreen", 'orgStudyIdInfo': {'id': 'ID-RCB 2022-A01488-35'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'L2 - Standard second read', 'description': 'Interpretation of mammograms done by a radiologist accredited to do second reading in France.'}, {'type': 'EXPERIMENTAL', 'label': 'L2-AI - AI-assisted second read', 'description': "Interpretation of mammograms done by the AI-based device. Mammograms deemed suspicious by the AI (i.e., receiving an AI global score higher than a defined threshold) will be interpreted by a radiologist accredited to do second reading in France. Mammograms assessed as negative or low suspicious by the AI won't be further interpreted by a radiologist.", 'interventionNames': ['Device: MammoScreen']}], 'interventions': [{'name': 'MammoScreen', 'type': 'DEVICE', 'description': 'Diagnostic reading aid for breast cancer screening', 'armGroupLabels': ['L2-AI - AI-assisted second read']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Aubagne', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Francoise LECRIVAIN', 'role': 'CONTACT'}], 'facility': 'Centre de radiologie Les Défensions', 'geoPoint': {'lat': 43.29276, 'lon': 5.57067}}, {'city': 'Draguignan', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent SIMONI', 'role': 'CONTACT'}], 'facility': 'Var Imagerie Medicale', 'geoPoint': {'lat': 43.53692, 'lon': 6.46458}}, {'city': 'Fréjus', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Eve BAQUE', 'role': 'CONTACT'}], 'facility': "VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper", 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'city': 'Fréjus', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Laurent CAUDMONT', 'role': 'CONTACT'}], 'facility': 'VAR IMAGERIE MEDICALE - Clinique Les Lauriers', 'geoPoint': {'lat': 43.43325, 'lon': 6.73555}}, {'city': 'Marseille', 'status': 'COMPLETED', 'country': 'France', 'facility': 'Cabinet de Radiologie du Cabot', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Marseille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Aurelie JALAGUIER', 'role': 'CONTACT'}], 'facility': 'Centre de Sénologie Mermoz', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'city': 'Saint-Raphaël', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Margaux POIRIER', 'role': 'CONTACT'}], 'facility': "VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon", 'geoPoint': {'lat': 43.42332, 'lon': 6.7735}}], 'centralContacts': [{'name': 'Brigitte Seradour', 'role': 'CONTACT', 'email': 'brigitteseradour@hotmail.fr', 'phone': '06 09 88 38 64'}, {'name': 'Patrice Heid', 'role': 'CONTACT', 'email': 'p.heid@depistage-cancerssud.org', 'phone': '06 09 07 83 67'}], 'overallOfficials': [{'name': 'Brigitte Seradour', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Therapixel', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}