Breast CancerLLTECHBreastNCT04292821
BIOPSY SCANNER LLTECH© Technology for Diagnosis of Breast Cancer
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 217 participants
- Where
- 1 siteFrance
- Study dates
- 28 Apr 2020to 15 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Patients consulting for breast lesion Bi Rads 4 or 5
Who may be able to join
- 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)
Who cannot join
- Patients under 18
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Keywords
- breast lesion, breast cancer, B3 breast lesion, atypical breast lesion, breast imaging, one-day breast diagnosis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients consulting for breast lesion Bi Rads 4 or 5 | Patients consulting for breast lesion Bi Rads 4 or 5 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the end of inclusion time
Secondary outcomes (6)
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
Measured: 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+)
Measured: 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
Measured: 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
Measured: At the end of inclusion time
Image atlas
Establishment of an image atlas facilitating the subsequent use of this technology by non-pathologists
Measured: At the end of inclusion time
Image recognition algorithm
Implementation of an image recognition algorithm for automated diagnosis
Measured: At the end of inclusion time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start28 Apr 2020
- Primary completion15 Apr 2022
- Study completion15 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine UZAN, Md PhD, Principal investigator, Pitié-Salpêtrière Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292821
- Sponsor's protocol ID
- APHP191059
- Acronym
- LLTECHBreast
- Status last verified
- Oct 2026
- First submitted
- 28 Feb 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Simon 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.
PubMed 37772663
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Study of BIOPSY SCANNER LLTECH© Technology in the Immediate Diagnosis of Breast Cancer
- ClinicalTrials.gov ID
- NCT04292821
- Acronym / sponsor ID
- LLTECHBreast / APHP191059
- Conditions
- Breast Cancer
- Keywords
- breast lesion, breast cancer, B3 breast lesion, atypical breast lesion, breast imaging, one-day breast diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 28 Apr 2020 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 15 Apr 2022 (actual)
- First posted
- 3 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients consulting for breast lesion Bi Rads 4 or 5 | – | –Patients consulting for breast lesion Bi Rads 4 or 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients consulting for breast lesion Bi Rads 4 or 5
Key inclusion criteria (1 listed)
- 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)
Key exclusion criteria (1 listed)
- Patients under 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Positive predictive value (PPV)
Time frame: At the end of inclusion time
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.
6 secondary outcomes
Reproductibility
Time frame: At the end of inclusion time
Efficiency for each histologic type
Time frame: At the end of inclusion time
Efficiency compared between breast tissue and lymph node
Time frame: At the end of inclusion time
Progression curve
Time frame: At the end of inclusion time
Image atlas
Time frame: At the end of inclusion time
Image recognition algorithm
Time frame: At the end of inclusion time
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Derived from this study: PubMed 37772663Simon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine UZAN, Md PhD principal investigator
Pitié-Salpêtrière Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive predictive value (PPV) (time frame: At the end of inclusion time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04292821, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.