A Study to Evaluate Volumetric Laser Endomicroscopy with Intelligent Real-time Image Segmentation (IRIS)

Overview

About this study

The purpose of this study is to examine how IRIS (Intelligent Real-time Image Segmentation) affects biopsy patterns in VLE (Volumetric Laser Endomicroscopy).

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • 18 years of age or older at the time of informed consent.
  • Barrett's esophagus greater than 2 cm in length.
  • Undergoing a scheduled upper endoscopy with VLE exam for surveillance as standard of care.

Exclusion Criteria: 

  • Less than 18 years old at the time of informed consent.
  • Unable to provide written informed consent.
  • Esophageal stenosis/stricture preventing VLE.
  • Esophagitis.
  • Severe medical comorbidities preventing endoscopy. 
  • Pregnancy.
  • Uncontrolled coagulopathy.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Cadman Leggett, M.D.

Closed for enrollment

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Francisco Ramirez, M.D.

Closed for enrollment

More information

Publications

  • Volumetric laser endomicroscopy (VLE) is a new wide-field advanced imaging technology for Barrett's esophagus (BE). No data exist on incremental yield of dysplasia detection. Our aim is to report the incremental yield of dysplasia detection in BE using VLE. Read More on PubMed
  • Little is known about the learning curve for image interpretation in volumetric laser endomicroscopy (VLE) in Barrett's esophagus (BE). The goal of this study was to calculate the learning curve, competence of image interpretation, sensitivity, specificity, and accuracy of VLE among novice users. Read More on PubMed
  • Volumetric laser endomicroscopy (VLE) is an advanced imaging system that provides a near-microscopic resolution scan of the esophageal wall layers up to 3-mm deep. VLE has the potential to improve detection of early neoplasia in Barrett's esophagus (BE). However, interpretation of VLE images is complex because of the large amount of data that need to be interpreted in real time. The aim of this study was to investigate the feasibility of a computer algorithm to identify early BE neoplasia on ex vivo VLE images. Read More on PubMed
  • Volumetric laser endomicroscopy (VLE) provides a circumferential scan of the esophageal wall layers and has potential to improve detection of neoplasia in Barrett's esophagus (BE). The novel VLE laser marking system enables direct in vivo marking of suspicious areas as identified on VLE. These laser marked areas can subsequently be targeted for biopsies. The aim was to evaluate the visibility and positional accuracy of laser marks (LMs) in different esophageal tissue types on white light endoscopy (WLE) and VLE. Read More on PubMed
  • The incidence of esophageal adenocarcinoma is on the rise despite widespread appreciation that the precursor lesion is Barrett's esophagus. Studies have shown that some patients known to have Barrett's esophagus develop cancer despite their enrollment in conventional endoscopic surveillance programs. This highlights the need for advanced endoscopic imaging to help identify early neoplasia and prevent its progression to esophageal cancer. Recently, a wide-field, second-generation optical coherence tomography endoscopic platform called volumetric laser endomicroscopy (VLE) was cleared by the Food and Drug Administration and made commercially available for advanced imaging in Barrett's esophagus. Read More on PubMed
  • Targeting neoplasia in Barrett's esophagus (BE) is challenging. Volumetric laser endomicroscopy (VLE) is a new imaging technique that allows for real time cross-sectional microstructure imaging that can detect BE neoplasia. The interobserver agreement among users in practice is unknown. Read More on PubMed
  • Volumetric laser endomicroscopy (VLE) provides a circumferential scan that enables visualization of the subsurface layers of the esophageal wall at 7 μm resolution. The aims of this study were to identify VLE features of Barrett's esophagus (BE) neoplasia and to develop a VLE prediction score. Read More on PubMed
  • Advanced imaging techniques used in the management of Barrett's esophagus include electronic imaging enhancement (e.g. narrow band imaging, flexible spectral imaging color enhancement, and i-Scan), chromoendoscopy, and confocal laser endomicroscopy. Electronic imaging enhancement is used frequently in daily practice, but use of the other advanced technologies is not routine. High-definition white light endoscopy and random four quadrant biopsy remain the standard of care for evaluation of Barrett's esophagus; this is largely due to the value of advanced imaging technologies not having been validated in large studies or in everyday practice. A new advanced imaging technology called volumetric laser endomicroscopy is commercially available in the United States. Its ease of use and rapid acquisition of high-resolution images make this technology very promising for widespread application. In this article we review the technology and its potential for advanced imaging in Barrett's esophagus. Read More on PubMed
  • Probe-based confocal laser endomicroscopy (pCLE) and volumetric laser endomicroscopy (VLE) (also known as frequency domain optical coherence tomography) are advanced endoscopic imaging modalities that may be useful in the diagnosis of dysplasia associated with Barrett's esophagus (BE). We performed pCLE examination in ex-vivo EMR specimens and compared the diagnostic performance of using the current VLE scoring index (previously established as OCT-SI) and a novel VLE diagnostic algorithm (VLE-DA) for the detection of dysplasia. Read More on PubMed
  • Methods and study aims: The incidence of esophageal cancer is rising despite increased surveillance efforts. Volumetric laser endomicroscopy (VLE) is a new endoscopic imaging tool that can allow for targeted biopsy of neoplasia in Barrett's esophagus. We report a series of 6 patients with long-segment Barrett's esophagus ( > 3 cm), who underwent a session of endoscopy with volumetric laser endomicroscopy, after a separate prior session of standard high-definition endoscopy with narrow band imaging (NBI) and random biopsies that did not reveal neoplasia. In all six patients, the first endoscopy was the index endoscopy diagnosing the Barrett's esophagus. All VLE exams were performed within 6 months of the previous endoscopy. In five patients, VLE-targeted biopsy resulted in upstaged disease/diagnosed dysplasia that then qualified the patient for endoscopic ablation therapy. In one patient, VLE localized a focus of intramucosal cancer that allowed for curative endoscopic mucosal resection. This case series shows that endoscopy with VLE can target neoplasia that cannot be localized by high-definition endoscopy with NBI and random biopsies. Read More on PubMed
  • The prevalence and clinical relevance of buried Barrett's glands (BB) after radiofrequency ablation (RFA) in Barrett's esophagus (BE) are debated. Recent optical coherence tomography studies demonstrated a high prevalence of BBs. Direct histological correlation, however, has been lacking. Volumetric laser endomicroscopy (VLE) is a second-generation optical coherence tomography system capable of scanning a large surface of the esophageal wall layers with low-power microscopy resolution. The aim was to evaluate whether post-RFA subsquamous glandular structures (SGSs), detected with VLE, actually correspond to BBs by pursuing direct histological correlation with VLE images. Read More on PubMed
  • Barrett's esophagus (BE) is among the most common conditions encountered by the gastroenterologist. In this document, the American College of Gastroenterology updates its guidance for the best practices in caring for these patients. These guidelines continue to endorse screening of high-risk patients for BE; however, routine screening is limited to men with reflux symptoms and multiple other risk factors. Acknowledging recent data on the low risk of malignant progression in patients with nondysplastic BE, endoscopic surveillance intervals are attenuated in this population; patients with nondysplastic BE should undergo endoscopic surveillance no more frequently than every 3-5 years. Neither routine use of biomarker panels nor advanced endoscopic imaging techniques (beyond high-definition endoscopy) is recommended at this time. Endoscopic ablative therapy is recommended for patients with BE and high-grade dysplasia, as well as T1a esophageal adenocarcinoma. Based on recent level 1 evidence, endoscopic ablative therapy is also recommended for patients with BE and low-grade dysplasia, although endoscopic surveillance continues to be an acceptable alternative. Given the relatively common recurrence of BE after ablation, we suggest postablation endoscopic surveillance intervals. Although many of the recommendations provided are based on weak evidence or expert opinion, this document provides a pragmatic framework for the care of the patient with BE. Read More on PubMed
  • Volumetric laser endomicroscopy (VLE) produces high-resolution, cross-sectional surface, and subsurface images for detecting neoplasia, targeting biopsies, and guiding real-time treatment. Read More on PubMed
  • Barrett's esophagus (BE) is a well-established premalignant condition for esophageal adenocarcinoma (EAC), a cancer that has increased in the Western world by nearly sixfold over the past three decades and is associated with a dismal 5-year survival rate (<20 %) especially when detected at a symptomatic state. Given the dramatic rise in EAC incidence and poor outcomes, much attention has focused on screening and surveillance in BE with a goal of identifying curable lesions and improving outcomes in patients with EAC. The limitations of current screening and surveillance strategies provide the necessary impetus to improve diagnostic accuracy and risk stratification of patients with BE. Biomarkers have the potential to predict risk of progression to cancer, identify patients most likely to respond to endoscopic eradication therapies, and ultimately influence patient management and outcomes. The goal of identifying such a biomarker or panel of biomarkers ready for clinical application remains elusive. This review highlights the recent advances in the field of biomarkers. It is increasingly being recognized that a single biomarker is suboptimal in accurate clinical risk stratification of individuals at highest risk for progression to cancer and an ideal risk stratification tool should include a panel of biomarkers in conjunction with clinical and endoscopic factors. Finally, we review advances in our screening strategies with use of Cytosponge, transnasal endoscopy, and tethered capsule endomicroscopy and surveillance strategies with use of advanced imaging techniques. Feasibility of these novel technologies for large population screening and surveillance needs to be assessed in future trials. Read More on PubMed
  • Endoscopic surveillance of Barrett's oesophagus (BO) provides an opportunity to detect early stage oesophageal adenocarcinoma (OAC). We sought to determine the proportion of OAC patients with a prior diagnosis of BO on a population basis and to evaluate the influence of a prior diagnosis of BO on survival, taking into account lead and length time biases. Read More on PubMed
  • The Prague C&M classification for Barrett's esophagus has found widespread acceptance but has only been validated by Barrett's experts scoring video sequences. To date, validation has been lacking for its application in routine practice during real-time endoscopy. The aim of this study was to evaluate agreement between Barrett's experts and community hospital endoscopists when using this classification to describe Barrett's esophagus and hiatal hernia length during real-time endoscopy. Read More on PubMed
  • Although patients with Barrett's esophagus commonly undergo endoscopic surveillance, its effectiveness in reducing mortality from esophageal/gastroesophageal junction adenocarcinomas has not been evaluated rigorously. Read More on PubMed
  • This article reviews reports on the prevalence of subsquamous intestinal metaplasia (SSIM) in patients with Barrett's esophagus, and the implications of SSIM in the neoplastic progression of Barrett's esophagus to esophageal adenocarcinoma. Read More on PubMed
  • Optical coherence tomography (OCT) is an optical technique that produces high-resolution images of the esophagus during endoscopy. OCT can distinguish specialized intestinal metaplasia (SIM) from squamous mucosa, but image criteria for differentiating intramucosal carcinoma (IMC) and high-grade dysplasia (HGD) from low-grade dysplasia (LGD), indeterminate-grade dysplasia (IGD), and SIM without dysplasia have not been validated. The purpose of this study was to establish OCT image characteristics of IMC and HGD in Barrett's esophagus. Read More on PubMed
  • The incidence of esophageal adenocarcinoma is rising dramatically. This increase may reflect increased disease burden, reclassification of related cancers, or overdiagnosis resulting from increased diagnostic intensity, particularly upper endoscopy for patients with gastroesophageal reflux disease or Barrett esophagus. Read More on PubMed
  • Surveying vs. performing resection in patients with high-grade dysplasia in Barrett's esophagus is debated because of concern about the accuracy of endoscopic biopsy diagnosis. The aim of this study was to investigate the accuracy of an endoscopic biopsy protocol in patients with neoplastic abnormalities in Barrett's epithelium without obvious esophageal cancer. Read More on PubMed
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CLS-20491574

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