OCT-Guided Tissue Sampling for Barrett's Esophagus
(IVLCM Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Massachusetts General Hospital
Must not be taking: Anti-platelets, Anti-coagulants, NSAIDs
Disqualifiers: Pregnancy, Hemostasis disorders, Esophageal strictures
No Placebo Group
Trial Summary
What is the purpose of this trial?The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.
Will I have to stop taking my current medications?
If you are taking anti-platelet medications, anti-coagulation medications, or NSAIDs, you will need to stop them before the procedure.
What data supports the effectiveness of the treatment IVLCM tethered capsule, In-Vivo Laser Capture Microdissection, Tethered Capsule Endomicroscope for Barrett's Esophagus?
Research shows that tethered capsule endomicroscopy (TCE) is safe and feasible for imaging Barrett's Esophagus, providing high-resolution images that can help identify abnormal areas needing further examination. Additionally, volumetric laser endomicroscopy (VLE) has been shown to improve the detection of abnormal tissue by 55% and increase neoplasia detection by 700% compared to standard methods, suggesting that these imaging techniques can enhance the management of Barrett's Esophagus.
12345Is OCT-guided tissue sampling for Barrett's Esophagus safe for humans?
Research shows that tethered capsule endomicroscopy (TCE), which uses optical coherence tomography (OCT) for imaging, is generally safe for humans. Studies involving patients with Barrett's Esophagus have demonstrated the feasibility and safety of this method, with no significant safety concerns reported.
12346How is the OCT-Guided Tissue Sampling for Barrett's Esophagus treatment different from other treatments?
This treatment uses a swallowable capsule with optical coherence tomography (OCT) to capture detailed images of the esophagus, allowing for non-invasive, high-resolution imaging of Barrett's esophagus without the need for sedation or traditional endoscopy. It is unique because it provides a comprehensive view of the esophageal tissue, potentially improving early detection and monitoring of the condition.
12347Eligibility Criteria
This trial is for adults over 18 who are undergoing an upper GI endoscopy with biopsy. It's not suitable for pregnant women, those with blood clotting disorders, esophageal strictures too narrow for the capsule, or patients on certain blood-thinning medications including NSAIDs.Inclusion Criteria
I am scheduled for an EGD procedure with a tissue sample collection.
Patients must be able to give informed consent.
I am over 18 years old.
Exclusion Criteria
You are pregnant.
I have a history of bleeding disorders.
I am taking blood thinners or NSAIDs currently.
+1 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo the IVLCM procedure using the tethered capsule endomicroscope to capture tissue samples for genomic analysis
5 months
Multiple visits for procedure and monitoring
Follow-up
Participants are monitored for safety and effectiveness after the IVLCM procedure
4 weeks
Participant Groups
The study tests a new device called IVLCM tethered capsule that captures high-resolution images of the esophagus to identify abnormal tissue in Barrett's Esophagus without sedation. Abnormal tissues are then analyzed genomically to predict cancer risk.
1Treatment groups
Experimental Treatment
Group I: IVLCM tethered capsule for biopsiesExperimental Treatment1 Intervention
IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Massachusetts General HospitalBoston, MA
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Who Is Running the Clinical Trial?
Massachusetts General HospitalLead Sponsor
National Institutes of Health (NIH)Collaborator
National Institute for Biomedical Imaging and Bioengineering (NIBIB)Collaborator
References
Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. [2020]Optical coherence tomography (OCT) is an optical diagnostic modality that can acquire cross-sectional images of the microscopic structure of the esophagus, including Barrett's esophagus (BE) and associated dysplasia. We developed a swallowable tethered capsule OCT endomicroscopy (TCE) device that acquires high-resolution images of entire gastrointestinal (GI) tract luminal organs. This device has a potential to become a screening method that identifies patients with an abnormal esophagus that should be further referred for upper endoscopy. Currently, the characterization of the OCT-TCE esophageal wall data set is performed manually, which is time-consuming and inefficient. Additionally, since the capsule optics optimally focus light approximately 500 µm outside the capsule wall and the best quality images are obtained when the tissue is in full contact with the capsule, it is crucial to provide feedback for the operator about tissue contact during the imaging procedure. In this study, we developed a fully automated algorithm for the segmentation of in vivo OCT-TCE data sets and characterization of the esophageal wall. The algorithm provides a two-dimensional representation of both the contact map from the data collected in human clinical studies as well as a tissue map depicting areas of BE with or without dysplasia. Results suggest that these techniques can potentially improve the current TCE data acquisition procedure and provide an efficient characterization of the diseased esophageal wall.
Tethered capsule en face optical coherence tomography for imaging Barrett's oesophagus in unsedated patients. [2022]Barrett's oesophagus (BE) screening outside the endoscopy suite can identify patients for surveillance and reduce mortality. Tethered capsule optical coherence tomography (OCT) can volumetrically image oesophageal mucosa in unsedated patients and detect features of BE. We investigated ultrahigh-speed tethered capsule swept-source OCT (SS-OCT), improved device design, developed procedural techniques and measured capsule contact, longitudinal pullback non-uniformity and patient toleration.
Assessment of Barrett's esophagus and dysplasia with ultrahigh-speed volumetric en face and cross-sectional optical coherence tomography. [2020]This study aimed to evaluate the use of ultrahigh-speed volumetric en face and cross-sectional optical coherence tomography (OCT) with micromotor catheters for the in vivo assessment of Barrett's esophagus and dysplasia.
Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. [2023]Tethered capsule endomicroscopy (TCE) involves swallowing a small tethered pill that implements optical coherence tomography (OCT) imaging, procuring high resolution images of the whole esophagus. Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi-center (5-site) clinical study.
Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. [2022]Volumetric laser endomicroscopy (VLE) uses optical coherence tomography (OCT) for real-time, microscopic cross-sectional imaging. A US-based multi-center registry was constructed to prospectively collect data on patients undergoing upper endoscopy during which a VLE scan was performed. The objective of this registry was to determine usage patterns of VLE in clinical practice and to estimate quantitative and qualitative performance metrics as they are applied to Barrett's esophagus (BE) management. All procedures utilized the NvisionVLE Imaging System (NinePoint Medical, Bedford, MA) which was used by investigators to identify the tissue types present, along with focal areas of concern. Following the VLE procedure, investigators were asked to answer six key questions regarding how VLE impacted each case. Statistical analyses including neoplasia diagnostic yield improvement using VLE was performed. One thousand patients were enrolled across 18 US trial sites from August 2014 through April 2016. In patients with previously diagnosed or suspected BE (894/1000), investigators used VLE and identified areas of concern not seen on white light endoscopy (WLE) in 59% of the procedures. VLE imaging also guided tissue acquisition and treatment in 71% and 54% of procedures, respectively. VLE as an adjunct modality improved the neoplasia diagnostic yield by 55% beyond the standard of care practice. In patients with no prior history of therapy, and without visual findings from other technologies, VLE-guided tissue acquisition increased neoplasia detection over random biopsies by 700%. Registry investigators reported that VLE improved the BE management process when used as an adjunct tissue acquisition and treatment guidance tool. The ability of VLE to image large segments of the esophagus with microscopic cross-sectional detail may provide additional benefits including higher yield biopsies and more efficient tissue acquisition. Clinicaltrials.gov NCT02215291.
Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. [2021]Biopsy surveillance protocols for the assessment of Barrett's esophagus can be subject to sampling errors, resulting in diagnostic uncertainty. Optical coherence tomography is a cross-sectional imaging technique that can be used to conduct volumetric laser endomicroscopy (VLE) of the entire distal esophagus. We have developed a biopsy guidance platform that places endoscopically visible marks at VLE-determined biopsy sites.
Feasibility of optical coherence tomography for the evaluation of Barrett's mucosa buried underneath esophageal squamous epithelium. [2022]The evaluation of Barrett's glands buried underneath esophageal squamous epithelium becomes increasingly important to achieve curative treatments. However, clinically available endoscopies have critical limitations in depicting the subsurface structure, resulting in non-curative treatments. Optical coherence tomography (OCT) can acquire a high-resolution cross-sectional image, equivalent to an 'optical biopsy'. We aimed to assess the feasibility of the in vivo use of probe-type OCT imaging to evaluate Barrett's mucosa buried underneath esophageal squamous epithelium METHODS: We conducted a single-center prospective study with 14 consecutive patients with Barrett's adenocarcinoma from 2008 to 2014. The enrolled patients were examined by a probe-type OCT in vivo, followed by en bloc endoscopic submucosal dissection (ESD) with electric marking. Then, the one-to-one correlations between the OCT images of the buried mucosa and their histological assessment were examined.