Breast CancerIMA-L2NCT05800132
Diagnostic Performance of Breast Cancer Screening Second Reading Process Assisted by AI
A study testing MammoScreen in people with Breast Cancer, run by Therapixel at 7 sites in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MammoScreen
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,000 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Jun 2023to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
France7 sites, 6 recruiting
- Recruiting
Centre de radiologie Les Défensions
Aubagne
Francoise LECRIVAIN
- Recruiting
Var Imagerie Medicale
Draguignan
Laurent SIMONI
- Recruiting
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Le Clipper
Fréjus
Marie-Eve BAQUE
- Recruiting
VAR IMAGERIE MEDICALE - Clinique Les Lauriers
Fréjus
Laurent CAUDMONT
- Completed
Cabinet de Radiologie du Cabot
Marseille
- Recruiting
Centre de Sénologie Mermoz
Marseille
Aurelie JALAGUIER
- Recruiting
VAR IMAGERIE MEDICALE - Centre d'Imagerie Médicale Epsilon
Saint-Raphaël
Margaux POIRIER
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- MammoScreen
- Keywords
- artificial intelligence, breast cancer screening, second reading
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammoScreenDevice
Diagnostic reading aid for breast cancer screening
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MammoScreen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recall rate
Number of patients that are called back for further examinations divided by the total number of patient receiving a second reading.
Measured: End of the inclusion period 24 months
Secondary outcomes (5)
Cancer detection rate
Number of biopsy proven cancers divided by the total number of patient receiving a second reading
Measured: End of the inclusion period 24 months
Sensitivity and Specificity
True and false-positive rate
Measured: 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
Measured: 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
Measured: End of the inclusion period 24 months
Reading time
Time needed [in seconds] to interpret a mammogram
Measured: End of the inclusion period 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2023
- Study start1 Jun 2023
- Primary completionAug 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Therapixel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brigitte Seradour, Principal investigator, Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05800132
- Sponsor's protocol ID
- ID-RCB 2022-A01488-35
- Acronym
- IMA-L2
- Status last verified
- Apr 2024
- First submitted
- 23 Mar 2023
- Last updated
- 12 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05800132
- Acronym / sponsor ID
- IMA-L2 / ID-RCB 2022-A01488-35
- Conditions
- Breast Cancer
- Keywords
- artificial intelligence, breast cancer screening, second reading
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- TherapixelIndustry (pharma, biotech, devices)
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 5 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Device: MammoScreenInterpretation 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. |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammoScreenDiagnostic reading aid for breast cancer screening | Device | L2-AI - AI-assisted second read |
Primary outcome
Recall rate
Time frame: 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.
5 secondary outcomes
Cancer detection rate
Time frame: End of the inclusion period 24 months
Sensitivity and Specificity
Time frame: End of the follow_up period 48 months
Economic impact
Time frame: End of the follow_up period 48 months
Time-to-results
Time frame: End of the inclusion period 24 months
Reading time
Time frame: End of the inclusion period 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Brigitte Seradour principal investigator
Centre Régional de Coordination des Dépistages des Cancers (CRCDC) Région Sud PACA
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MammoScreen in people with Breast Cancer, run by Therapixel at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Brigitte Seradour (06 09 88 38 64, brigitteseradour@hotmail.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recall rate (time frame: End of the inclusion period 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.