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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:
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.
All mammograms eligible for a second reading, and included in the study, go through 2 arms:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L2 - Standard second read | No Intervention | Interpretation of mammograms done by a radiologist accredited to do second reading in France. | |
| L2-AI - AI-assisted second read | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MammoScreen | Device | Diagnostic reading aid for breast cancer screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recall rate | Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading. | End of the inclusion period 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer detection rate | Number of biopsy proven cancers divided by the total number of patient receiving a second reading | End of the inclusion period 24 months |
| Sensitivity and Specificity | True and false-positive rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brigitte Seradour | Contact | 06 09 88 38 64 | brigitteseradour@hotmail.fr | |
| Patrice Heid | Contact | 06 09 07 83 67 | p.heid@depistage-cancerssud.org |
| Name | Affiliation | Role |
|---|---|---|
| Brigitte Seradour | Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre de radiologie Les Défensions | Recruiting | Aubagne | France |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| End of the follow_up period 48 months |
| Economic impact | Difference in direct medical costs between the two arms Difference in annual budgetary impact on the French National Health Insurance between the two arms | End of the follow_up period 48 months |
| Time-to-results | Time period [in days] between the day of the screening and the access to results | End of the inclusion period 24 months |
| Reading time | Time needed [in seconds] to interpret a mammogram | End of the inclusion period 24 months |
| Var Imagerie Medicale | Recruiting | Draguignan | France |
|
| VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper | Recruiting | Fréjus | France |
|
| VAR IMAGERIE MEDICALE - Clinique Les Lauriers | Recruiting | Fréjus | France |
|
| Cabinet de Radiologie du Cabot | Completed | Marseille | France |
| Centre de Sénologie Mermoz | Recruiting | Marseille | France |
|
| VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon | Recruiting | Saint-Raphaël | France |
|
| D017437 |
| Skin and Connective Tissue Diseases |