OFDI Capsule Imaging for Barrett's Esophagus

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Antiplatelets, Anticoagulants, NSAIDs

Disqualifiers: Hemostasis disorders, Esophageal strictures, others

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to diagnose Barrett's Esophagus, a condition where the esophagus lining changes, increasing cancer risk. The study uses an Optical Frequency Domain Imaging (OFDI) capsule that participants swallow, allowing doctors to see inside the esophagus more clearly. This trial targets individuals already scheduled for an EGD (a common procedure to examine the esophagus) and excludes those with conditions like bleeding disorders or esophageal strictures (narrowing of the esophagus). Participants will assist researchers in determining the effectiveness and precision of the OFDI capsule in identifying Barrett's Esophagus. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance future diagnostic methods.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking anti-platelet medications, anti-coagulation medications, and NSAIDs (non-steroidal anti-inflammatory drugs) before the procedure.

What prior data suggests that the OFDI capsule is safe for diagnosing Barrett's Esophagus?

Research continues to assess the safety of the OFDI capsule for humans. Although specific safety data for this capsule is not yet available, the technology it employs has been tested in other studies, suggesting some confidence in its safety. In past research, patients with Barrett's Esophagus used the capsule without sedation, indicating it might be well-tolerated.

While exact safety statistics are unavailable, the capsule's inclusion in ongoing studies is promising. Experts believe it could be safe enough for broader use. However, more information is necessary to fully understand any potential risks or side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OFDI Capsule Imaging for Barrett's Esophagus because it offers a non-invasive way to both mark and image the esophageal tissue. Unlike traditional endoscopy, which requires a more invasive procedure, this method involves simply swallowing a capsule. The capsule uses Optical Frequency Domain Imaging (OFDI) to capture detailed images of the esophagus, potentially allowing for earlier and more accurate detection of changes in the tissue. This could improve monitoring and treatment outcomes for patients with Barrett's Esophagus by making the process more comfortable and accessible.

What evidence suggests that the OFDI capsule is effective for diagnosing Barrett's Esophagus?

Research has shown that Optical Frequency Domain Imaging (OFDI) can assist doctors in diagnosing Barrett's Esophagus by providing clear, detailed images. In this trial, participants will swallow the OFDI capsule, which performs marking and imaging. OFDI captures pictures of the esophagus that reveal changes possibly linked to Barrett's Esophagus. This technology examines different layers of the esophagus, not just the surface, making it easier to detect early signs of the condition. OFDI has been tested on both healthy individuals and those with Barrett's, demonstrating promise as a less invasive method to gather important information. ^{1 2 6 7 8}

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 over 18 who can consent to participate and are scheduled for an EGD, a type of esophagus examination. It's not suitable for those with narrowings (strictures) in the esophagus, bleeding disorders, or those taking certain blood-thinning medications including NSAIDs.

Inclusion Criteria

I am over 18 years old.

I am scheduled for an upper GI endoscopy.

Patients must be able to give informed consent

Exclusion Criteria

I have a narrowing in my esophagus.

I am taking blood thinners or NSAIDs currently.

I have a history of bleeding or clotting disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Experimental Procedure

Participants swallow the OFDI capsule, undergo marking and imaging of the esophagus

20 minutes

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OFDI Capsule Marking

Trial Overview

The study is evaluating a new capsule-based technology called OFDI Capsule Marking to diagnose Barrett's Esophagus. This involves swallowing a capsule that captures detailed images of the esophagus lining during an EGD procedure.

How Is the Trial Designed?

Group I: OFDI Capsule Marking and Imaging Experimental Treatment 1 Intervention

Participant will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

withpower.com

withpower.com/trial/phase-barrett-esophagus-5-2014-f2532

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 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT02947971

Pilot Study for TCE Imaging of the Esophagus Using an ...

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 participants to ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3567218/

Tethered capsule endomicroscopy enables less-invasive ...

The tethered capsule employs optical frequency domain (OFDI) imaging technology to provide cross-sectional architectural morphologic data that has ...

4.

pmc.ncbi.nlm.nih.gov

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

Interobserver Agreement for the Detection of Barrett's ...

Optical frequency domain imaging (OFDI) is a second-generation form of optical coherence tomography (OCT) providing comprehensive cross-sectional views of ...

5.

dash.harvard.edu

dash.harvard.edu/bitstreams/7312037c-ff57-6bd4-e053-0100007fdf3b/download

Tethered capsule endomicroscopy enables less-invasive ...

The tethered capsule employs optical frequency domain (OFDI) imaging5 technology to provide cross-sectional architectural morphologic data that has previously.

6.

withpower.com

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

OFDI Capsule Imaging for Barrett's Esophagus

Is Optical Frequency Domain Imaging (OFDI) safe for use in humans? The research does not provide specific safety data for humans, but Optical Frequency ...

7.

aging.networkofcare.org

aging.networkofcare.org/sanmateo/CommunityResources/ClinicalTrials/Detail/NCT02204150?keyword=%22Esophagus%22

Study to Image the Esophagus Using the OFDI Capsule

A total of 56 subjects with Barrett's Esophagus, EoE and healthy volunteers will be asked to swallow the OFDI capsule while being unsedated.

8.

pmc.ncbi.nlm.nih.gov

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

Emerging optical methods for surveillance of Barrett's ...

Results of a clinical study using OFDI showed 60% sensitivity and 80% specificity in assignment of squamous or columnar tissues. Figure 3D shows ...