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| Name | Class |
|---|---|
| Vivactis M2Research | INDUSTRY |
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Based on data from a series of patients who underwent screening mammography with a "normal" or "benign" first-reading result. The main objective of the study is to evaluate the possibilities of subtracting from the second reading of breast cancer screening a population of examinations for which the risk of discovering cancer is close to zero, using an AI system (here the MammoScreen™ system).
This is a retrospective multicenter study of mammography imaging data contained in the PACS (Picture Archiving and Communication System) of six radiology centers located in the Rhône, Puy de dôme, Cantal and Haute-Loire départements.
In order to be able to collect two-year follow-up data, the files analyzed will concern all women who received a screening mammogram during the years 2015, 2016, 2017, 2018 and 2019. More recent mammograms will be excluded.
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of real negatives | Percentage of cases negatived by MammoScreen (considered benign by the system), and for which no cancer was detected at the end of the L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10). We distinguish two sub-populations: L2- and L2+ with BDD- (in addition to L2-). | Week 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of real positives | Percentage of MammoScreen-positive cases for which cancer was detected in L2 (according to the different risk levels of the MammoScreen software - score from 1 to 10). | Week 8 |
| Percentage of false negatives |
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Inclusion Criteria:
Exclusion Criteria:
- Mammography not performed as part of organized screening
Female breast cancer
As this was a retrospective exploratory study, with no prior hypothesis, the number of subjects required was not calculated.
The study population (n=55,000) represents, for the radiology practices concerned, all mammograms examined in second reading by the Auvergne Rhône Alpes regional cancer screening coordination center between 2015 and 2019.
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| Name | Affiliation | Role |
|---|---|---|
| Christophe TOURASSE, MD | Hôpital Privé Jean Mermoz | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Privé Jean Mermoz | Lyon | 69008 | France |
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Percentage of MammoScreen-positive cases with an L2 ultimately considered negative (L2- or L2 + with DBB-), for which interval cancer is detected (according to the different risk levels of the MammoScreen software - score from 1 to 10).
| Week 8 |