Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
Breast Cancer
De qué trata este estudio
El registro no identifica actualmente este estudio como reclutando. Consulta su estado antes de planificar una evaluación.
- Tipo de estudio
- De intervención
- Fase
- No aplica
- Rango de edad
- 50 años - 74 años
- Sexo admitido
- Femenino
- Voluntarios sanos
- Aceptados
- Participantes
- 3500 Real
Estos son puntos de partida, no una decisión de elegibilidad. El equipo debe revisar todos los requisitos.
Las explicaciones y la navegación están en español. Los textos proporcionados por el registro, incluidos títulos, resúmenes y criterios, se conservan en su idioma original. Puedes pedir orientación en español a WCR.
Acerca de la investigación
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.
The main questions it aims to answer are:
- will the experimental pathway be non-inferior to the standard pathway?
- will the experimental pathway be economically superior to the standard pathway?
Participants 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.
Leer la descripción completa
All mammograms eligible for a second reading, and included in the study, go through 2 arms:
- Conventional second reading by a radiologist accredited to do second reading in France (L2 control arm),
- 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.
The 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.
Clinical performances and economical impacts of both scenarii will be compared.
¿Quién podría participar?
La lista siguiente contiene el texto del patrocinador. Puede incluir condiciones, tratamientos previos, resultados de pruebas y otros requisitos. Aparecer en tu búsqueda no significa que califiques.
Inclusion Criteria:
- Affiliated to the French social security system
- Whose mammograms meet the following characteristics: 4 (2 per breast, CC and MLO) meeting local regulatory standards and with correct DICOM metadata,
- 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
- 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,
- Having completed and signed the informed consent form.
Exclusion Criteria:
- Woman with breast implants,
- With clinical symptoms of breast cancer,
- With a history of breast surgery (breast reduction or surgery for benign lesion),
- Pregnant or breastfeeding,
- With medical conditions that may interfere with her ability to understand the requirements of the protocol or give informed consent,
- Deprived of liberty by judicial or administrative order,
- 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.
Tratamiento, grupos y participación
El registro puede describir tratamientos y duración sin incluir un calendario completo. Pide al equipo las visitas, procedimientos, riesgos, costos y alternativas. Mantén tu atención habitual salvo que tu médico te indique un cambio.
- Asignación
- Sin asignación al azar
- Enmascaramiento
- Sin enmascaramiento
L2 - Standard second read
Interpretation of mammograms done by a radiologist accredited to do second reading in France.
L2-AI - AI-assisted second read
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.
Device: MammoScreen
MammoScreen DEVICE
Diagnostic reading aid for breast cancer screening
Qué evalúan los investigadores
Estas medidas indican qué se estudia. No prueban que un tratamiento funcione.
Medidas principales
Recall rate
Plazo: End of the inclusion period 24 months
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
Medidas secundarias
Cancer detection rate
Plazo: End of the inclusion period 24 months
Number of biopsy proven cancers divided by the total number of patient receiving a second reading
Sensitivity and Specificity
Plazo: End of the follow_up period 48 months
True and false-positive rate
Economic impact
Plazo: End of the follow_up period 48 months
Difference in direct medical costs between the two arms Difference in annual budgetary impact on the French National Health Insurance between the two arms
Time-to-results
Plazo: End of the inclusion period 24 months
Time period \[in days\] between the day of the screening and the access to results
Reading time
Plazo: End of the inclusion period 24 months
Time needed \[in seconds\] to interpret a mammogram
Revisa las tablas completas y sus limitaciones en el registro oficial.
Abrir resultados oficiales ↗Centros de investigación (7)
El estado general puede diferir del estado de un centro. Confirma la disponibilidad antes de trasladarte.
7 centros
Centre de radiologie Les DéfensionsAubagne, FranceEstado desconocido
Var Imagerie MedicaleDraguignan, FranceEstado desconocido
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le ClipperFréjus, FranceEstado desconocido
VAR IMAGERIE MEDICALE - Clinique Les LauriersFréjus, FranceEstado desconocido
Cabinet de Radiologie du CabotMarseille, FranceEstado desconocido
Centre de Sénologie MermozMarseille, FranceEstado desconocido
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale EpsilonSaint-Raphaël, FranceEstado desconocido
Equipo y fechas
- Patrocinador principal
- Therapixel
- Inicio del estudio
- 1 jun 2023 Real
- Finalización primaria
- 1 sept 2025 Real
- Finalización del estudio
- 1 sept 2025 Real
- Primera publicación
- 5 abr 2023 Real
- Última actualización
- 9 nov 2026 Real
Contactos oficiales del estudio
No hay un contacto central indicado. Revisa los centros y el registro oficial.
Título oficial del estudio
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
Consulta a Wellness Clinical Research
Tu mensaje va a WCR, incluso si otra organización realiza este estudio. WCR puede orientarte, pero podría no realizar este estudio, tener acceso a su equipo ni poder inscribirte.
Fuente: API v2 de ClinicalTrials.gov. Patrocinadores e investigadores envían la información. La NLM no aprueba la seguridad ni la ciencia de todos los estudios registrados. Aviso del registro.
Consultado: 12 nov 2026 · Última actualización del registro: 9 nov 2026