Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство MammoScreen
  Diagnostic reading aid for breast cancer screening

Первичные конечные точки

• Recall rate [Срок оценки: End of the inclusion period 24 months]

Вторичные конечные точки (5)

• Cancer detection rate [Срок оценки: End of the inclusion period 24 months]
• Sensitivity and Specificity [Срок оценки: End of the follow_up period 48 months]
• Economic impact [Срок оценки: End of the follow_up period 48 months]
• Time-to-results [Срок оценки: End of the inclusion period 24 months]
• Reading time [Срок оценки: End of the inclusion period 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Франция · 7 центров

• Centre de radiologie Les Défensions — Aubagne
• Var Imagerie Medicale — Draguignan
• VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper — Fréjus
• VAR IMAGERIE MEDICALE - Clinique Les Lauriers — Fréjus
• Cabinet de Radiologie du Cabot — Marseille
• Centre de Sénologie Mermoz — Marseille
• VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon — Saint-Raphaël

Идентификаторы

NCT: NCT05800132 · ID-RCB 2022-A01488-35

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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