Breast NeoplasmsETOLENCT02959398
Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions
A study testing Standard mammography and Standard mammography and tomosynthesis in people with Breast Neoplasms and Tomosynthesis, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Neoplasms, Tomosynthesis, BRCA1 Protein
- What is being tested?
- Standard mammography and Standard mammography and tomosynthesis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,000 participants
- Where
- 2 sitesFrance
- Study dates
- 20 Nov 2017to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
- Patient over 18 years old
- Signed informed consent
Who cannot join
- Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
- Patient unable to give informed consent for physical, mental, or legal reasons.
- Patient not affiliated with French Social Security Insurance.
- Patient under treatment for breast cancer.
- When mammography is not recommended according to good practice by the French Health Authority (HAS).
- Pregnant patient.
Trial locations and contacts
2 sites in 1 country.
France2 sites, 2 recruiting
- Recruiting
hopital Saint-Louis
Paris, 75010
matthieu resche-rigon, 142499742 ext. +33, matthieu.resche-rigon@univ-paris-diderot.fr
- Recruiting
Hopital Tenon
Paris, 75020
Isabelle THOMASSIN- NAGGARA, Pr, isabelle.thomassin@aphp.fr
About this study
Official title: EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.
The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.
- Conditions
- Breast Neoplasms, Tomosynthesis, BRCA1 Protein, BRCA2 Protein
- Being tested
- Standard mammography, Standard mammography and tomosynthesis
- Medical subject headings
- Breast Neoplasms, Fanconi Anemia, Complementation Group D1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard mammographyDevice
Standard mammography
Standard mammography and tomosynthesisDevice
Standard mammography and tomosynthesis
| Study group | Role | What they receive |
|---|---|---|
| standard mammography | Active comparator | standard mammography Receives: Device: Standard mammography |
| standard mammography and tomosynthesis | Experimental | standard mammography and tomosynthesis Receives: Device: Standard mammography and tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast Imaging-Reporting And Data System (BI-RADS) scale
The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard.
Measured: Day 1
Secondary outcomes (7)
Criteria for a poor prognosis
The visibility (presence or absence) of signs of poor prognosis criteria. We will compare the visibility of poor prognosis criteria seen on mammography + ultrasound and seen on tomosynthesis with synthetic mammography + ultrasound.
Measured: Day 1
Number of additional examinations
Needs for supplementary breast imaging exams and biopsies
Measured: Day 30
The number of ultrasound exams
Measured: Day 30
Total radiation dose
Measured: Day 30
Cost of the diagnostic strategies
Measured: Day 30
Agreement between readers
The reproducibility of the interpretation of tomosynthesis will be assessed with differences of classifications BiRadsT observed between the two radiologists
Measured: Day 1
Cumulative incidence of Breast cancer diagnosis
Cumulative incidence of Breast cancer diagnosis among women with benign at after primary evaluation
Measured: Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study start20 Nov 2017
- Primary completionMay 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02959398
- Sponsor's protocol ID
- P120121
- Acronym
- ETOLE
- Status last verified
- Nov 2017
- First submitted
- 7 Nov 2016
- Last updated
- 24 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
- ClinicalTrials.gov ID
- NCT02959398
- Acronym / sponsor ID
- ETOLE / P120121
- Conditions
- Breast Neoplasms, Tomosynthesis, BRCA1 Protein, BRCA2 Protein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- May 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 9 Nov 2016 (estimated)
- 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.
Tomosynthesis is an innovative technique developed in digital mammography for obtaining a sectional image of the breast. Mammography has the main disadvantage of being an imaging projection that creates overlays, which eliminates tomosynthesis.
The objective of this study is to evaluate if the BI-RADS classification obtained by tomosynthesis with synthetic mammography is superior to that obtained by conventional mammography in terms of specificity while not inferior in terms of sensitivity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard mammography | Active comparator | Device: Standard mammographystandard mammography |
| standard mammography and tomosynthesis | Experimental | Device: Standard mammography and tomosynthesisstandard mammography and tomosynthesis |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5)
- Patient over 18 years old
- Signed informed consent
Key exclusion criteria (6 listed)
- Patients at high risk of breast cancer, mutations BRCA 1 (BReast CAncer gene 1) or BRCA 2 (BReast CAncer gene 2) carriers, Li Fraumeni, or history of thoracic radiation will be excluded because of their greater sensitivity to ionizing radiation.
- Patient unable to give informed consent for physical, mental, or legal reasons.
- Patient not affiliated with French Social Security Insurance.
- Patient under treatment for breast cancer.
- When mammography is not recommended according to good practice by the French Health Authority (HAS).
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 |
|---|---|---|
| Standard mammographyStandard mammography | Device | standard mammography |
| Standard mammography and tomosynthesisStandard mammography and tomosynthesis | Device | standard mammography and tomosynthesis |
Primary outcome
Breast Imaging-Reporting And Data System (BI-RADS) scale
Time frame: Day 1
The primary evaluation parameter will be the classification error of tumors according to the BiRads scale obtained by mammography (BiRadsM) and by tomosynthesis (BiRadsT) according to the gold standard.
7 secondary outcomes
Criteria for a poor prognosis
Time frame: Day 1
Number of additional examinations
Time frame: Day 30
The number of ultrasound exams
Time frame: Day 30
Total radiation dose
Time frame: Day 30
Cost of the diagnostic strategies
Time frame: Day 30
Agreement between readers
Time frame: Day 1
Cumulative incidence of Breast cancer diagnosis
Time frame: Month 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2017.
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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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard mammography and Standard mammography and tomosynthesis in people with Breast Neoplasms and Tomosynthesis, run by Assistance Publique - Hôpitaux de Paris at 2 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 24 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact cedric De Bazelaire, MD PHD (142499133 ext. +33, cedric.de-bazelaire@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast Imaging-Reporting And Data System (BI-RADS) scale (time frame: Day 1). 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 24 Nov 2017; AzTrials last refreshed its copy on 8 Nov 2026.