OFDI Capsule Imaging for Barrett's Esophagus
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
Disqualifiers: Over 70, Swallowing issues, Pregnancy, others
No Placebo Group
Trial Summary
What is the purpose of this trial?The goal of this research is to test a distal scanning capsule and a compact redesigned version of the OFDI imaging system in healthy and BE subjects to assess ease of use, safety and feasibility in preparation for its use in a multicenter clinical trial.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
What data supports the effectiveness of the treatment OFDI Imaging for Barrett's Esophagus?
OFDI Imaging is a high-speed imaging technique that provides detailed cross-sectional images of tissues, which can help detect changes in the esophagus associated with Barrett's Esophagus. It offers a resolution sufficient for identifying microscopic tissue structures, potentially improving diagnosis over traditional methods like upper endoscopy.
12345Is Optical Frequency Domain Imaging (OFDI) safe for use in humans?
The research does not provide specific safety data for humans, but Optical Frequency Domain Imaging (OFDI) has been used in studies involving the esophagus, suggesting it is considered safe enough for such research.
14678How is OFDI Imaging treatment different from other treatments for Barrett's Esophagus?
OFDI Imaging is unique because it provides high-speed, detailed cross-sectional images of the esophagus with a resolution of about 7-10 micrometers, allowing for comprehensive visualization of tissue architecture without the need for sedation. This non-invasive imaging technique can cover the entire distal esophagus quickly, potentially improving diagnostic accuracy compared to standard endoscopy.
167910Eligibility Criteria
This trial is for adults aged 18-70 who can swallow pills and have been diagnosed with Barrett's Esophagus (BE), or are healthy volunteers. Participants must not eat solid food for 4 hours and only clear liquids for 2 hours before the procedure. Pregnant individuals, those over 70, with a strong gag reflex, esophageal fistula/strictures smaller than the capsule cannot join.Inclusion Criteria
Subjects must be able to give informed consent
I am between 18 and 70 years old.
I have been diagnosed with Barrett's esophagus.
+1 more
Exclusion Criteria
Pregnancy. If the subject is unsure, she will be asked to take a pregnancy test.
I cannot swallow pills or capsules.
I am over 70 years old.
+2 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
1-2 weeks
Imaging
Participants undergo OFDI imaging of the esophagus using a tethered capsule
5-7 minutes
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after imaging
1-2 weeks
Participant Groups
The study is testing a new type of imaging using an Optical Frequency Domain Imaging (OFDI) capsule that scans the esophagus. It aims to check how easy and safe it is to use this compact system in people with BE or healthy subjects before a larger trial.
1Treatment groups
Experimental Treatment
Group I: OFDI ImagingExperimental Treatment1 Intervention
Experimental OFDI Imaging
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 Cancer Institute (NCI)Collaborator
National Institutes of Health (NIH)Collaborator
References
Optical frequency domain imaging system and catheters for volumetric imaging of the human esophagus. [2021]Barrett's esophagus (BE) is a metaplastic disorder that can undergo dysplastic progression, leading to esophageal adenocarcinoma. Upper endoscopy is the standard of care for screening for BE, but this technique has a relatively low diagnostic accuracy and high cost due to the requirement of conscious sedation. Optical frequency domain imaging (OFDI) is a high-speed imaging modality that generates cross-sectional images of tissues with a resolution of approximately 10μm that is sufficient for detecting microscopic tissue architecture. In combination with a balloon-centering catheter, this method enables BE diagnosis over the entire distal esophagus.
Advanced endoscopic imaging in Barrett's oesophagus: a review on current practice. [2021]Over the last few years, improvements in endoscopic imaging technology have enabled identification of dysplasia and early cancer in Barrett's oesophagus. New techniques should exhibit high sensitivities and specificities and have good interobserver agreement. They should also be affordable and easily applicable to the community gastroenterologist. Ideally, these modalities must exhibit the capability of imaging wide areas in real time whilst enabling the endoscopist to specifically target abnormal areas. This review will specifically focus on some of the novel endoscopic imaging modalities currently available in routine practice which includes chromoendoscopy, autofluorescence imaging and narrow band imaging.
Optical molecular imaging for detection of Barrett's-associated neoplasia. [2021]Recent advancements in the endoscopic imaging of Barrett's esophagus can be used to probe a wide range of optical properties that are altered with neoplastic progression. This review summarizes relevant changes in optical properties as well as imaging approaches that measures those changes. Wide-field imaging approaches include narrow-band imaging that measures changes in light scattering and absorption, and autofluorescence imaging that measure changes in endogenous fluorophores. High-resolution imaging approaches include optical coherence tomography, endocytoscopy, confocal microendoscopy, and high-resolution microendoscopy. These technologies, some coupled with an appropriate contrast agent, can measure differences in glandular morphology, nuclear morphology, or vascular alterations associated with neoplasia. Advances in targeted contrast agents are further discussed. Studies that have explored these technologies are highlighted; as are the advantages and limitations of each.
Improved Visibility of Barrett's Esophagus with Linked Color Imaging: Inter- and Intra-Rater Reliability and Quantitative Analysis. [2019]To evaluate the usefulness of linked color imaging (LCI) and blue LASER imaging (BLI) in Barrett's esophagus (BE) compared with white light imaging (WLI).
Recent advances in molecular imaging of premalignant gastrointestinal lesions and future application for early detection of barrett esophagus. [2021]Recent advances in optical molecular imaging allow identification of morphologic and biochemical changes in tissues associated with gastrointestinal (GI) premalignant lesions earlier and in real-time. This focused review series introduces high-resolution imaging modalities that are being evaluated preclinically and clinically for the detection of early GI cancers, especially Barrett esophagus and esophageal adenocarcinoma. Although narrow band imaging, autofluorescence imaging, and chromoendoscopy are currently applied for this purpose in the clinic, further adoptions of probe-based confocal laser endomicroscopy, high-resolution microendoscopy, optical coherence tomography, and metabolomic imaging, as well as imaging mass spectrometry, will lead to detection at the earliest and will guide predictions of the clinical course in the near future in a manner that is beyond current advancements in optical imaging. In this review article, the readers will be introduced to sufficient information regarding this matter with which to enjoy this new era of high technology and to confront science in the field of molecular medical imaging.
Interobserver agreement for the detection of Barrett's esophagus with optical frequency domain imaging. [2022]Optical frequency domain imaging (OFDI) is a second-generation form of optical coherence tomography (OCT) providing comprehensive cross-sectional views of the distal esophagus at a resolution of ~7 μm.
Image-guided biopsy in the esophagus through comprehensive optical frequency domain imaging and laser marking: a study in living swine. [2022]Random biopsy esophageal surveillance can be subject to sampling errors, resulting in diagnostic uncertainty. Optical frequency domain imaging (OFDI) is a high-speed, 3-dimensional endoscopic microscopy technique. When deployed through a balloon-centering catheter, OFDI can automatically image the entire distal esophagus (6.0 cm length) in approximately 2 minutes.
Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. [2022]Patients with Barrett's esophagus (BE) show increased risk of developing esophageal adenocarcinoma and are routinely examined using upper endoscopy with biopsy to detect neoplastic changes. Angle-resolved low coherence interferometry (a/LCI) uses in vivo depth-resolved nuclear morphology measurements to detect dysplasia. We assessed the clinical utility of a/LCI in the endoscopic surveillance of patients with BE.
Co-registered spectrally encoded confocal microscopy and optical frequency domain imaging system. [2022]Spectrally encoded confocal microscopy and optical frequency domain imaging are two non-contact optical imaging technologies that provide images of tissue cellular and architectural morphology, which are both used for histopathological diagnosis. Although spectrally encoded confocal microscopy has better transverse resolution than optical frequency domain imaging, optical frequency domain imaging can penetrate deeper into tissues, which potentially enables the visualization of different morphologic features. We have developed a co-registered spectrally encoded confocal microscopy and optical frequency domain imaging system and have obtained preliminary images from human oesophageal biopsy samples to compare the capabilities of these imaging techniques for diagnosing oesophageal pathology.
Optical coherence tomography in the gastrointestinal tract. [2005]Optical coherence tomography (OCT) is a high-resolution, cross-sectional optical imaging technique that allows in situ imaging of tissue by measuring back-reflected light. OCT provides images in real time with a resolution approaching that of conventional histopathology, but without the need for tissue removal. OCT imaging can be performed endoscopically to visualize gastrointestinal tissue using a fiberoptic catheter passed through the instrument channel of a conventional endoscope. The resolution of OCT allows visualization of the different layers of gastrointestinal epithelium and the differentiation of Barrett's epithelium from normal gastric and squamous mucosa. OCT has also been used to image esophageal adenocarcinoma and colonic polyps. Recent developments include Doppler OCT, spectroscopic OCT, and ultrahigh-resolution OCT, which can visualize nuclei within single cells. Although still in its infancy as a clinical tool, OCT currently provides high-resolution images over the same imaging depth as conventional mucosal biopsy, and may prove to be a useful and minimally invasive technique for evaluating gastrointestinal tissue, particularly for early neoplastic changes.