Clinical trial · Interventional
Evaluation of Tomosynthesis for Characterization and the Management of Breast Lesions
EVALUATION DE LA TOMOSYNTHESE DANS LA CARACTERISATION ET LA PRISE EN CHARGE DES LESIONS MAMMAIRES : "ETOLE"
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| BRCA1 Protein | — | UNRESOLVED | — |
| BRCA2 Protein | — | UNRESOLVED | — |
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Tomosynthesis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Standard mammography | Device | — | UNRESOLVED |
| Standard mammography and tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- standard mammography
- description
- standard mammography
- interventionNames
- Device: Standard mammography
- type
- EXPERIMENTAL
- label
- standard mammography and tomosynthesis
- description
- standard mammography and tomosynthesis
- interventionNames
- Device: Standard mammography and tomosynthesis
Primary outcomes (1)
- measure
- Breast Imaging-Reporting And Data System (BI-RADS) scale
- timeFrame
- Day 1
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient having clinical or breast imaging abnormalities classified as BiRads 3, 4, 5 (Table 1). (5) * Patient over 18 years old * Signed informed consent Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available