OFDI Capsule Imaging for Barrett's Esophagus

Overseen By Elizabeth Biddle, RN

Age: 18+

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

20 Participants Needed

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. ^{1 2 3 4 5}

Is 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. ^{1 4 6 7 8}

How 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. ^{1 6 7 9 10}

Research Team

Guillermo Tearney, MD, PhD

Principal Investigator

Massachusetts General Hospital

Eligibility 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 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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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 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]

References

1. Poland pubmed.ncbi.nlm.nih.gov

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

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

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

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

Optical molecular imaging for detection of Barrett's-associated neoplasia. [2021]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Improved Visibility of Barrett's Esophagus with Linked Color Imaging: Inter- and Intra-Rater Reliability and Quantitative Analysis. [2019]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Recent advances in molecular imaging of premalignant gastrointestinal lesions and future application for early detection of barrett esophagus. [2021]

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

Interobserver agreement for the detection of Barrett's esophagus with optical frequency domain imaging. [2022]

7. 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]

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

Detection of dysplasia in Barrett's esophagus with in vivo depth-resolved nuclear morphology measurements. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Co-registered spectrally encoded confocal microscopy and optical frequency domain imaging system. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Optical coherence tomography in the gastrointestinal tract. [2005]