BIOPSY SCANNER LLTECH© Technology for Diagnosis of Breast Cancer (LLTECHBreast)

Performance Study of BIOPSY SCANNER LLTECH© Technology in the Immediate Diagnosis of Breast Cancer

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.

Study Overview

• Status: Unknown
• Conditions: Breast Cancer

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.

• Study Type: Observational
• Enrollment (Anticipated): 204

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Recruiting
    • Hôpital de la Pitié Salpêtrière
    • Contact: Catherine UZAN, Md PhD; Phone Number: 01 42 17 81 14; Email: catherine.uzan@aphp.fr
    • Contact: Geoffroy CANLORBE, Md PhD; Phone Number: 01 42 17 81 29; Email: geoffroy.canlorbe@aphp.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients consulting for breast lesion Bi Rads 4 or 5

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients consulting for breast lesion Bi Rads 4 or 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value (PPV)	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.	At the end of inclusion time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reproductibility	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	At the end of inclusion time
Efficiency for each histologic type	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 according to the histological characteristics of the tumor (according to grade, according to luminal A / luminal B profile / triple negative / HEr2 3+)	At the end of inclusion time
Efficiency compared between breast tissue and lymph node	Comparison of the sensitivity, specificity, positive predictive value and negative predictive value of the diagnosis of breast cancer by the analysis of BIOPSY	At the end of inclusion time
Progression curve	Number of samples required to reach the objective of the same diagnostic capacity as the pathologist from these images	At the end of inclusion time
Image atlas	Establishment of an image atlas facilitating the subsequent use of this technology by non-pathologists	At the end of inclusion time
Image recognition algorithm	Implementation of an image recognition algorithm for automated diagnosis	At the end of inclusion time

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Catherine UZAN, Md PhD, Pitié Salpêtrière Hospital AP-HP

Study record dates

Study Major Dates

• Study Start (Actual): April 28, 2020
• Primary Completion (Anticipated): September 15, 2021
• Study Completion (Anticipated): September 15, 2021

Study Registration Dates

• First Submitted: February 28, 2020
• First Submitted That Met QC Criteria: February 28, 2020
• First Posted (Actual): March 3, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 25, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: breast cancer; breast imaging; breast lesion; B3 breast lesion; atypical breast lesion; one-day breast diagnosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: APHP191059

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No