Clinical trial · Observational
BIOPSY SCANNER LLTECH© Technology for Diagnosis of Breast Cancer
Performance Study of BIOPSY SCANNER LLTECH© Technology in the Immediate Diagnosis of Breast Cancer
- 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)
Breast cancer is a frequent pathology and the speed of initial diagnosis makes it possible to improve the course of care and to reduce the anxiety of the patients. For a complete assessment, several biopsies may be necessary, including lymph node biopsies. Once the histological sample has been taken, a preparation is necessary (time consuming technician) then a reading by a pathologist requiring at least 48-72h. Cytology allows immediate diagnosis, but it requires the presence of a pathologist in the collection room. Finally, some biopsies can be non-contributory (if there is not enough tissue removed) and require new samples. A tool allowing immediate control of the tissue and an initial diagnosis without mobilizing the pathologist (who will make the result complete with immunohistochemistry) would make it possible to anticipate the next course of care and facilitate treatment. The BIOPSY SCANNER LLTECH © technology would allow images on fresh unprepared tissue to obtain images allowing immediate diagnosis by a non-pathologist, the same tissue could then be technical for a complete analysis by the pathologist. The investigators propose a study evaluating the diagnostic capacities by non pathologists from images obtained by the BIOPSY SCANNER LLTECH © technology on breast and lymph node biopsies. Based on this study, an atlas on breast lesions could be created to allow a broader evaluation of this technology in daily practice in diagnostic of breast pathology.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Patients consulting for breast lesion Bi Rads 4 or 5
- description
- Patients consulting for breast lesion Bi Rads 4 or 5
Primary outcomes (1)
- measure
- Positive predictive value (PPV)
- timeFrame
- At the end of inclusion time
- description
- Positive predictive value (PPV) of the diagnosis of breast cancer by the analysis of images BIOPSY SCANNER LLTECH © carried out by a senior radiologist taking as reference the results provided by histology on tissue section.
Secondary outcomes (6)
- measure
- Reproductibility
- timeFrame
- At the end of inclusion time
- description
- Comparison of sensitivity, specificity, positive predictive value and negative predictive value of the diagnosis of breast cancer by the analysis of BIOPSY SCANNER LLTECH © images by a junior radiologist versus senior radiologist versus pathologist versus surgeon
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 18 years old requiring a breast biopsy for an birads 4 or 5 nodular radiological lesion or lymph node for a lymph node judged to be radiologically suspect (cortex thickened by more than 3 mm) Exclusion Criteria: * Patients under 18
References
Publications (1)
- DERIVEDSimon A, Badachi Y, Ropers J, Laurent I, Dong L, Da Maia E, Bourcier A, Canlorbe G, Uzan C. Value of high-resolution full-field optical coherence tomography and dynamic cell imaging for one-stop rapid diagnosis breast clinic. Cancer Med. 2023 Oct;12(19):19500-19511. doi: 10.1002/cam4.6560. Epub 2023 Sep 29. PMID 37772663