BIOPSY SCANNER LLTECH Technology for Diagnosis of Breast Cancer

Description

In France, 59,000 new cases of breast cancer are diagnosed per year, but with systematic screening, more than 400,000 women will be biopsied each year. Less than 50% of women in France respond to organized screening and one of the reasons put forward is in particular the anxiety linked to waiting for the result of the biopsy if it turns out to be necessary.The BIOPSY SCANNER LLTECH technology would allow images on fresh unprepared tissue to obtain images allowing immediate diagnosis by a non-pathologist (Annex 2: description of the manufacturer), the same tissue could then be technically analyzed for a complete analysis pathologic.

The BIOPSY SCANNER LLTECH is an optical imaging device for the microscopic evaluation of deep tissue samples. It enables rapid imaging of samples on a cellular scale, in a non-invasive and non-destructive manner, and to reveal their microarchitecture and cellular organization.

The Biopsy Scanner uses the patented technique of full field white light interferometry. This technique is considered to be the equivalent of optical resolution ultrasound ( 1 m) in 3 directions. A sample placed in the system is illuminated by an inconsistent light source.

The light reflected by the sample is collected by the interferometer and interferes with the light reflected by a reference mirror. This interference signal is recorded by a camera. The interferometric technique and the coherence properties of the light source make it possible to select the signal which comes from a limited volume in the depth of the sample. This property of the system is called optical sectioning and ensures good axial imaging resolution (1 m). The transverse resolution is good (1.5 m) thanks to the integration of microscope objectives in the interferometer.

Currently, it is necessary for an immediate diagnosis of breast cancer to have a second expert cytologist doctor (it is a difficult learning technique) in the radiologist's room to check that the tissue removed is sufficient. In addition, a second sample is necessary to obtain a complete histology. The BIOPSY SCANNER LLTECH technology could allow patients to be informed more quickly while avoiding mobilizing on-site expertise and taking 2 samples.The investigators hypothesize that the BIOPSY SCANNER LLTECH technique will allow the radiologist to provide immediately after the breast or lymph node biopsy, on fresh unprepared tissue, a positive or negative diagnosis of cancer, with sufficient diagnostic performance to consider its generalization.

The study will also allow us to see whether a learning curve is necessary and to assess its duration. It should be noted that there is no reason to think a priori that the sensitivities / specificities will be different depending on the type of biopsy (breast or lymph node) which will therefore be analyzed in the same group in the main analysis.

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