Breast CancerIMADESNCT07882420
Role of Artificial Intelligence in Breast Cancer Screening Via Mammography
A study testing Transpara software in people with Breast Cancer, run by Centre Antoine Lacassagne at 2 sites in France.
Trial summary
to evaluate the diagnostic performance of radiologists using the Transpara™ Incepto® software to interpret 2D mammograms with tomosynthesis as part of breast cancer screening Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Transpara software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,222 participants
- Where
- 2 sitesFrance
- Study dates
- 31 Jan 2027to 30 Sep 2032
- Phase
- Interventional
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A woman referred for a bilateral mammogram as part of individual or organised screening,
- Patient aged 18 or over,
- A patient who has read the information leaflet and signed the informed consent form,
- A patient with health insurance cover.
Who cannot join
- Patients with a history of breast cancer,
- Patients with a history of breast surgery (cosmetic and/or therapeutic),
- Patients with a history of radiotherapy to the breast,
- Vulnerable populations and participants as defined in Articles 64 to 68 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites
Institut Paoli Calmette
Marseille
Estelle PIPON, doctor, 04 91 22 33 33 ext. +33, pipone@ipc.unicancer.fr
Centre Antoine Lacassagne
Nice
Laura ELIKND, doctor, 04 92 03 14 66 ext. +33, laura.elkind@nice.uniacncer.fr
About this study
to evaluate the diagnostic performance of radiologists using the Transpara™ Incepto® software to interpret 2D mammograms with tomosynthesis as part of breast cancer screening
- Conditions
- Breast Cancer
- Being tested
- Transpara software
- Keywords
- screening
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transpara softwareDevice
use of transpara software for breast cancer screening
| Study group | Role | What they receive |
|---|---|---|
| global arm | Experimental | use of artificial intelligence software for breast cancer screening Receives: Device: Transpara software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity (diagnostic performance) of radiologist using the Transpara software
Medical conclusion of radiologist using the Transpara software at baseline compared to radiologist's decision alone at 2 years, or the result of the biopsy (positive during the follow-up period or negative at 2 years).
Measured: 2 years
Secondary outcomes (5)
Rate of change in care following the use of the software Transpara by radiologist compared to the decision taken before by the radiologist alone
Rate of change in care following the use of the software Transpara by radiologist compared to the decision taken before by the radiologist alone
Measured: Baseline
Diagnostic performance of radiologist alone and radiologist using the Transpara software
Compare the diagnostic performance of the radiologist working alone and the radiologist using the software at baseline
Measured: Baseline
Radiologist evaluation false-positive rate obtained by radiologist using the Transpara software
To assess the false-positive rate generated by the radiologist using the Transpara™ Incepto software
Measured: Baseline
Adverses events assessed by CTCAE 6.0
To assess adverse events associated with additional diagnostic investigations prompted by the use of the Transpara™ Incepto® software.
Measured: 2 years
comparaison of diagnosis performance of radiologist alone and radiologist using the Transpara software
To compare the diagnostic performance of the Transpara™ Incepto® software with that of the radiologist alone.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start31 Jan 2027 (estimated)
- Primary completion31 Mar 2031 (estimated)
- Study completion30 Sep 2032 (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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,222 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Antoine Lacassagne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laura ELKIND, doctor, Principal investigator, Centre Antoine Lacassagne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882420
- Sponsor's protocol ID
- 2022/25
- Acronym
- IMADES
- Status last verified
- Oct 2026
- First submitted
- 5 Oct 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided