Preclinical studies have been carried out on a variety of tissues with up to 100% detection
Skin Drexel University Medical School, Philadelphia PA, USA
Following preliminary studies, a clinical study is underway at Drexel University Medical School. The purpose of the study is to document the performance of the LLTech system to assess margins during Mohs surgery and significantly shorten the surgery cycle. More than 200 samples were imaged under surgical conditions. An atlas of images with reading criteria is being developed, and a first validation of diagnostic accuracy (i.e. sensitivity and specificity) will soon be carried out.
American dermatologists appear ready to use the faster, easier-to-use LLTech system to replace the frozen section technique, which is currently a bottleneck, so that they can provide a better patient experience and serve more patients each day.
Breast Tenon Hospital, Paris, France – Institut Curie, Paris, France
75 breast specimens were imaged from 22 patients (21 women, 1 man) with a mean age of 58 (range: 25-83). Using Light-CT images, two breast pathologists were able to distinguish normal/benign tissue from lesional with a sensitivity of 94% and 90%, and specificity of 75% and 79% respectively.
Prostate biopsies Cochin Hospital, Paris, France – UCLA, CA, USA – Beijing Hospital, Beijing, China
The latest paper on prostate biopsies was published in February, 2016 (Yang). Doctors could detect aggressive cancers (Gleason score 6 & above) with a sensitivity of 100% and a specificity of 96%, after a training based on an atlas of images and associated reading criteria. Doctors are interested in a radical paradigm shift in the diagnosis and treatment of prostate cancer:
- Direct real-time diagnosis at the urologist’s or radiologist’s office, followed immediately by ad hoc treatment (focal ablation).
- Automated real-time computer diagnosis.
A large-scale multicentric study (150 patients, 1800 biopsies) is currently underway at Hopital Cochin (Paris France) and the Hopital d’Angers (Angers France). More than 700 biopsies have been imaged to date, and their diagnostic accuracy will be soon assessed by doctors from different specialties – pathology, urology, radiology.
Bladder Cochin Hospital, Paris, France
Images of 24 specimens were read blindly by three non-pathologists readers: two resident urologists and a junior bio-medical engineer, who were asked to notify the presence of muscle and tumor. Results showed that after appropriate training, 96% accuracy could be obtained on both tumour and muscle detection. Implementation of FFOCT as a quality control and primo-diagnosis tool for transurethral bladder resections in the urology suite is feasible and lets envision high value for the patient.
Kidney Weill Cornell Medical College, New York, USA
A uropathologist correctly classified as neoplastic/non-neoplastic 100% of 25 kidney specimens, based on the FFOCT images alone, and gave the exact tumor subtype diagnosis in 80% of cases. Besides, FFOCT allowed to identify all major components of a normal kidney, such as glomeruli, tubules, blood vessels and interstitium. This makes FFOCT a valuable tool for rapid evaluation of ex vivo kidney tissue e.g. for intraoperative margin assessment and kidney biopsy adequacy (see paper by Jain et al., 2015).
ENT Institut Gustave Roussy, Villejuif, France
A study was carried out on 57 ENT specimens from 32 patients. Two pathologists, blinded to the patient history, and even to the specimen organ, read the FFOCt images and reached high diagnosis performance: 89% sensitivity and 84% specificity. This shows high promise for the clinical value of Full-Field OCT imaging in the management of patients with Head and Neck cancers (see paper by De Leeuw, 2015).
Colorectal polyps Cochin Hospital, Paris, France
Over 20 colorectal biopsies and colorectal polyps were imaged and analysed blindly by pathologists and endoscopists. Tissu malignancy could be determined (benign, pre-cancerous, cancerous). Furthermore, the LLTech device was used week under real coloscopy conditions at Cochin Hospital, Paris, to test real-time feasibility. Excised polyps were imaged within minutes by FFOCT in the coloscopy room, and the images immediately transmitted to the pathologist office through the hospital network. The pathologist could thus give a feedback to the endoscopist during the coloscopy on the malignancy of the polyp. FFOCT holds great potential as a polyp triage tool during coloscopy.
Restoration of fertility following cancer treatment LUMC, Leiden, Netherlands
A group from Leiden University Medical Center demonstrated the safety and efficacy of the LLTech system in selecting ovarian autografts to restore fertility following cancer treatment (see 2016-Peters: preservation of samples and detection of normal and cancerous structures with the LLTech device).
Lymph nodes Tenon Hospital, Paris, France
60 lymph nodes from patients at Tenon Hospital were imaged with Light-CT. An image atlas was created from the samples. Features of normal and suspect nodes were identified in the Light-CT images and compared with histology. Blind diagnosis based on Light-CT images alone resulted in sensitivity of 93% and specificity of 90%. Second look diagnosis on the same image set resulted in sensitivity of 100% and specificity of 97%, indicating that following adequate training, Light-CT is an effective non-invasive diagnostic tool for sentinel node biopsy qualification.
Brain Hôpital Saint Anne, Paris, France
Demonstration of Light-CT imaging on 18 human brain samples. Light-CT showed potential as an intraoperative tool for determining tissue architecture and content in minutes. Myelin fibers, neurons, microcalcifications, tumor cells, microcysts, and vessels were identified. Good correspondence with histological slides was demonstrated, allowing clinical use for tissue selection.
Cornea Institut de la vision, Paris, France
Human donor (8) and pathological (5) corneas were observed with the Light-CT Scanner, and compared with standard histology and preoperative spectral domain OCT. Light-CT image features were comparable to the details provided by conventional histology, and at higher resolution when compared with spectral domain OCT. Light-CT, by enabling detailed study of corneal structures, permits detection of corneal conditions that are currently difficult to identify in eye banks, such as keratoconus, absence of Bowman’s layer, or corneal scars. It appears promising as a complementary technique to current assessment methods of human donor corneas. (Ile-de-France Cornea Bank at Sainte Antoine Hospital, Paris)
Ongoing preclinical studies include: prostate biopsies, bladder resections, lung biopsies (Cochin Hospital, Paris); skin Mohs surgery (Drexel University Medical School, Philadelphia PA, USA).