OFDI Capsule Imaging for Barrett's Esophagus

Overseen By Juleen Guoy, RN

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Over 70, Swallowing issues, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

120 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging system called Experimental OFDI Imaging, which uses a small capsule to view the esophagus. It focuses on individuals with Barrett's Esophagus (a condition where the esophagus lining changes), GERD (frequent acid reflux), or EoE (a disease causing inflammation in the esophagus). The trial aims to determine if this imaging method is easy to use, safe, and effective. Individuals with Barrett's Esophagus, GERD, or EoE who can swallow pills easily might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to the development of innovative imaging technology.

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 prior data suggests that this OFDI imaging is safe for Barrett's Esophagus?

Research has shown that Optical Frequency Domain Imaging (OFDI) is generally safe. Studies have used OFDI to examine the esophagus, and patients have tolerated it well. These studies report no serious side effects. OFDI uses light to create images inside the body, enhancing doctors' ability to see clearly. This technique often detects issues in the esophagus, such as Barrett's Esophagus, where stomach acid damages the esophagus lining. Overall, OFDI appears safe and easy for patients, making it a promising tool for future medical use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about OFDI Capsule Imaging for Barrett's Esophagus because it offers a non-invasive way to capture detailed images of the esophagus. Unlike traditional endoscopy, which requires sedation and can be uncomfortable, this capsule can be swallowed easily, making the process much more patient-friendly. Additionally, OFDI provides high-resolution images that could improve early detection and monitoring of Barrett's Esophagus, potentially leading to better outcomes and less reliance on more invasive procedures.

What evidence suggests that OFDI Imaging is effective for Barrett's Esophagus?

Research has shown that Optical Frequency Domain Imaging (OFDI), which participants in this trial will receive, is a high-quality imaging method that can enhance the accuracy of diagnosing Barrett's esophagus. This technique captures detailed, 3D images, providing a clearer view of the esophagus. Early results suggest that OFDI can detect problems more effectively than some traditional imaging methods, potentially identifying early signs that other tests might miss. Although still under evaluation, OFDI shows promise in making the diagnosis of Barrett's esophagus more reliable. ^{3 6 7 8 9}

Who Is on the Research Team?

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 have been diagnosed with Barrett's esophagus.

I haven't eaten solid food for 4 hours and only had clear liquids for 2 hours before the procedure.

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Experimental OFDI Imaging

Trial Overview 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.

How Is the Trial Designed?

Group I: OFDI Imaging Experimental Treatment 1 Intervention

Experimental OFDI Imaging

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

Published Research Related to This Trial

A study involving nine subjects and 64 OFDI image regions showed that trained readers can reliably differentiate between Barrett's esophagus (BE), squamous mucosa, and gastric cardia mucosa, achieving excellent interobserver agreement (κ = 0.866).

The intraobserver agreement was also very high (κ = 0.975), indicating that individual readers consistently interpret the images accurately over time, which supports the efficacy of OFDI in clinical settings for diagnosing esophageal conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interobserver agreement for the detection of Barrett's esophagus with optical frequency domain imaging. Sauk, J., Coron, E., Kava, L., et al.[2022]

Angle-resolved low coherence interferometry (a/LCI) has shown high accuracy (86%) in detecting dysplasia in patients with Barrett's esophagus during routine endoscopic surveillance, based on measurements of nuclear size at specific tissue depths.

The a/LCI method demonstrated excellent sensitivity (100%) and good specificity (84%) for identifying dysplastic tissue, indicating its potential as a reliable tool for early detection of neoplastic changes in Barrett's esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. Terry, NG., Zhu, Y., Rinehart, MT., et al.[2022]

The study successfully demonstrated that laser marking of targeted esophageal sites identified through optical frequency domain imaging (OFDI) is highly accurate, with a success rate of 97.07% in marking the correct locations in an experimental study involving 5 swine.

All laser marks were clearly visible during endoscopy, and the thermal damage caused by the laser was limited to superficial mucosal layers, showing signs of partial healing within 2 days, indicating a safe approach for guiding biopsies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Image-guided biopsy in the esophagus through comprehensive optical frequency domain imaging and laser marking: a study in living swine. Suter, MJ., Jillella, PA., Vakoc, BJ., et al.[2022]

The newly developed co-registered imaging system combines spectrally encoded confocal microscopy and optical frequency domain imaging, allowing for enhanced visualization of tissue morphology in oesophageal biopsy samples.

While spectrally encoded confocal microscopy offers better resolution, optical frequency domain imaging provides deeper tissue penetration, potentially improving the diagnosis of oesophageal pathology by revealing different morphological features.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Co-registered spectrally encoded confocal microscopy and optical frequency domain imaging system. Kang, DK., Suter, MJ., Boudoux, C., et al.[2022]

Optical frequency domain imaging (OFDI) offers a high-resolution imaging technique (about 10μm) that can improve the diagnostic accuracy for Barrett's esophagus (BE) compared to standard endoscopy, which has limitations in accuracy and is costly due to sedation requirements.

When used with a balloon-centering catheter, OFDI allows for comprehensive imaging of the entire distal esophagus, potentially enhancing early detection of dysplastic changes that could lead to esophageal adenocarcinoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical frequency domain imaging system and catheters for volumetric imaging of the human esophagus. Gora, M., Yoo, H., Suter, MJ., et al.[2021]

Recent advancements in endoscopic imaging techniques for Barrett's esophagus allow for the detection of optical property changes associated with cancer progression, utilizing methods like narrow-band imaging and autofluorescence imaging.

High-resolution imaging technologies, such as optical coherence tomography and confocal microendoscopy, can effectively identify morphological changes in tissues, enhancing the ability to diagnose neoplasia and potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical molecular imaging for detection of Barrett's-associated neoplasia. Thekkek, N., Anandasabapathy, S., Richards-Kortum, R.[2021]

Recent advancements in endoscopic imaging technologies have significantly improved the detection of dysplasia and early cancer in Barrett's esophagus, emphasizing the need for high sensitivity and specificity in these techniques.

Novel imaging modalities like chromoendoscopy, autofluorescence imaging, and narrow band imaging are now being used in routine practice, allowing gastroenterologists to effectively target abnormal areas during examinations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advanced endoscopic imaging in Barrett's oesophagus: a review on current practice. Singh, R., Mei, SC., Sethi, S.[2021]

Recent advancements in optical molecular imaging techniques allow for the early and real-time detection of gastrointestinal premalignant lesions, which is crucial for identifying early GI cancers like Barrett esophagus and esophageal adenocarcinoma.

Current clinical methods such as narrow band imaging and autofluorescence imaging are being enhanced by new technologies like probe-based confocal laser endomicroscopy and optical coherence tomography, promising even earlier detection and better predictions of clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in molecular imaging of premalignant gastrointestinal lesions and future application for early detection of barrett esophagus. Ko, KH., Han, NY., Kwon, CI., et al.[2021]

Linked color imaging (LCI) significantly improved the visibility of Barrett's esophagus (BE) compared to white light imaging (WLI), with 44.4% of endoscopists noting improvement, especially benefiting trainees.

Blue LASER imaging (BLI) showed no significant improvement over WLI, highlighting LCI as the more effective imaging technique for assessing short-segment BE in this study of 63 patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved Visibility of Barrett's Esophagus with Linked Color Imaging: Inter- and Intra-Rater Reliability and Quantitative Analysis. Takeda, T., Nagahara, A., Ishizuka, K., et al.[2019]

Optical coherence tomography (OCT) is a promising imaging technique that allows real-time, high-resolution visualization of gastrointestinal tissues without the need for biopsies, making it a minimally invasive option for evaluating conditions like Barrett's esophagus and esophageal adenocarcinoma.

Recent advancements in OCT technology, such as Doppler and ultrahigh-resolution OCT, enhance its ability to visualize cellular structures, potentially improving early detection of neoplastic changes in gastrointestinal tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the gastrointestinal tract. Brand, S., Poneros, JM., Bouma, BE., et al.[2005]

Citations

1. giejournal.org giejournal.org/article/S0016-5107(09)02535-8/pdf

Somewhere over the rainbow The endoscopic management of Barrett's esophagus associated neoplasia has traditionally been done by using endoscopic imaging with random biopsies, ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0016508514000171

The Clinical Consequences of Advanced Imaging ... These newer imaging techniques are not more effective in standard surveillance of patients with BE because the prevalence of early neoplasia is low and HD-WLE ...

3. withpower.com withpower.com/trial/phase-barrett-esophagus-3-2016-2065f

OFDI Capsule Imaging for Barrett's Esophagus Optical frequency domain imaging (OFDI) offers a high-resolution imaging technique (about 10μm) that can improve the diagnostic accuracy for Barrett's esophagus ...

4. wjgnet.com wjgnet.com/1948-5190/full/v8/i5/259

Endoscopic imaging of Barrett's esophagus Optical frequency domain imaging (OFDI), also known as volumetric laser endomicroscopy (VLE), allows for high resolution, high-speed acquisition of larger areas ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3732518/

Interobserver Agreement for the Detection of Barrett's ... A novel form of OCT called optical frequency domain imaging (OFDI) uses a balloon catheter which centers helically scanning optics to acquire three-dimensional ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01439594

Optical Frequency Domain Imaging (OFDI) Assessment in ... As the purpose of the study is to assess the response of the esophagus to radio frequency (RF) ablation, and the degree of residual Barrett's Esophagus (BE) ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S0016510715022786

Safety and feasibility of volumetric laser endomicroscopy in ... VLE is a safe procedure for ... Kava, et al. Interobserver agreement for the detection of Barrett's esophagus with optical frequency domain imaging.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5019028/

Emerging optical methods for surveillance of Barrett's ... Light offers numerous advantages for rapidly visualising the oesophagus, and advanced optical methods are being developed for wide-field and ...

9. giejournal.org giejournal.org/article/S0016-5107(15)02278-6/abstract

Safety and feasibility of volumetric laser endomicroscopy in ... Volumetric laser endomicroscopy (VLE) produces high-resolution, cross-sectional surface, and subsurface images for detecting neoplasia, targeting biopsies, ...