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

130 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

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.

How does the OFDI Capsule Imaging treatment for Barrett's Esophagus differ from other treatments?

The OFDI Capsule Imaging treatment is unique because it uses a capsule with advanced imaging technology to non-invasively detect Barrett's Esophagus, unlike traditional methods that require endoscopy with sedation. This capsule captures high-resolution images at a fast rate, allowing for detailed examination of the esophagus without the need for invasive procedures. ^{1 2 3 4 5}

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

Subject 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

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]

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 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. United States 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. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Usefulness of Non-magnifying Narrow Band Imaging in EVIS EXERA III Video Systems and High-Definition Endoscopes to Diagnose Dysplasia in Barrett's Esophagus Using the Barrett International NBI Group (BING) Classification. [2019]

3. Australia pubmed.ncbi.nlm.nih.gov

Diagnostic accuracy of a novel third generation esophageal capsule as a non-invasive detection method for Barrett's esophagus: A pilot study. [2021]

4. Poland pubmed.ncbi.nlm.nih.gov

Optical frequency domain imaging system and catheters for volumetric imaging of the human esophagus. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Advanced endoscopic imaging in Barrett's oesophagus: a review on current practice. [2021]