Clinical trial NCT04292821: BIOPSY SCANNER LLTECH© Technology for Diagnosis of Breast Cancer
Official title: Performance Study of BIOPSY SCANNER LLTECH© Technology in the Immediate Diagnosis of Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast lesion
breast cancer
B3 breast lesion
atypical breast lesion
breast imaging
one-day breast diagnosis
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-03-03
Enrollment: 204
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients consulting for breast lesion Bi Rads 4 or 5

Brief summary: 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.

Detailed 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 μm) 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 μm). The transverse resolution is good (1.5 μm) 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.

Eligibility criteria: 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

Primary outcomes:
measure: Positive predictive value (PPV)
timeFrame: At the end of inclusion time
Secondary outcomes:
measure: Reproductibility
timeFrame: At the end of inclusion time
measure: Efficiency for each histologic type
timeFrame: At the end of inclusion time
measure: Efficiency compared between breast tissue and lymph node
timeFrame: At the end of inclusion time
measure: Progression curve
timeFrame: At the end of inclusion time
measure: Image atlas
timeFrame: At the end of inclusion time
measure: Image recognition algorithm
timeFrame: At the end of inclusion time
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital de la Pitié Salpêtrière
Study officials:
affiliation: Pitié-Salpêtrière Hospital (AP-HP)
name: Catherine UZAN, Md PhD
role: PRINCIPAL_INVESTIGATOR
References: