OCT-Guided Tissue Sampling for Barrett's Esophagus

(IVLCM Trial)

Overseen By Camila Salcedo, CRC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anti-platelets, Anti-coagulants, NSAIDs

Disqualifiers: Pregnancy, Hemostasis disorders, Esophageal strictures

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 months

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to identify issues in the esophagus (the tube that carries food to the stomach) and better predict the risk of esophageal adenocarcinoma. The trial employs a swallowable capsule, known as the IVLCM tethered capsule, which captures detailed images of the esophagus and collects abnormal tissue for genetic testing. This approach could improve screening and prevention for individuals with Barrett's Esophagus, a condition where the esophagus lining changes and may lead to cancer. Individuals with Barrett's Esophagus who can swallow the capsule without issues might be suitable candidates for this trial. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance early detection and prevention strategies.

Will I have to stop taking my current medications?

If you are taking anti-platelet medications, anti-coagulation medications, or NSAIDs, you will need to stop them before the procedure.

What prior data suggests that this device is safe for use in Barrett's Esophagus screening?

Research has shown that the IVLCM tethered capsule, which employs optical coherence tomography (OCT), has undergone safety testing in individuals with Barrett's esophagus. In these studies, patients swallowed the capsule without sedation, remaining awake during the procedure.

The capsule captured detailed images of the esophagus and collected tissue samples for further analysis. Studies have found this method both practical and safe for patients, with no reports of serious side effects, indicating that the procedure is generally well-tolerated.

This capsule offers a new way to monitor esophageal conditions and may aid in preventing esophageal cancer. Safety data from previous studies provide some confidence in its use. However, like any medical procedure, there is a small risk of side effects, so discussing any concerns with a doctor is important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the IVLCM tethered capsule for Barrett's Esophagus because it offers a new, less invasive way to obtain tissue samples for genomic sequencing. Unlike traditional endoscopic biopsies, which can be uncomfortable and require sedation, this capsule is swallowed, making the process simpler and more accessible. This innovative approach enables the detailed assessment of esophageal adenocarcinoma (EAC) risk, potentially leading to earlier and more personalized treatment strategies.

What evidence suggests that this device is effective for Barrett's Esophagus?

Previous studies have shown that the IVLCM tethered capsule can identify abnormal tissue in patients with Barrett's Esophagus (BE). In this trial, participants will use the IVLCM tethered capsule, which employs a special imaging technique to capture detailed pictures of the esophagus. It finds and collects tissue samples directly from the esophagus. These samples can then undergo genetic analysis to help predict the risk of developing Esophageal Adenocarcinoma (EAC). Research suggests that this method could enhance BE screening accuracy by targeting the most concerning areas for further testing. ^{1 2 4 5 6}

Who Is on the Research Team?

Gary Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are undergoing an upper GI endoscopy with biopsy. It's not suitable for pregnant women, those with blood clotting disorders, esophageal strictures too narrow for the capsule, or patients on certain blood-thinning medications including NSAIDs.

Inclusion Criteria

I am scheduled for an EGD procedure with a tissue sample collection.

I am over 18 years old.

Patients must be able to give informed consent.

Exclusion Criteria

You are pregnant.

I have a history of bleeding disorders.

I am taking blood thinners or NSAIDs currently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo the IVLCM procedure using the tethered capsule endomicroscope to capture tissue samples for genomic analysis

5 months

Multiple visits for procedure and monitoring

Follow-up

Participants are monitored for safety and effectiveness after the IVLCM procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• IVLCM tethered capsule

Trial Overview The study tests a new device called IVLCM tethered capsule that captures high-resolution images of the esophagus to identify abnormal tissue in Barrett's Esophagus without sedation. Abnormal tissues are then analyzed genomically to predict cancer risk.

How Is the Trial Designed?

Group I: IVLCM tethered capsule for biopsies Experimental Treatment 1 Intervention

IVLCM tethered capsule for obtaining biopsies for genomic sequencing of BE for the assessment of EAC risk.

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 Institute for Biomedical Imaging and Bioengineering (NIBIB)

Collaborator

Trials

102

Recruited

21,600+

Published Research Related to This Trial

Ultrahigh-speed tethered capsule swept-source optical coherence tomography (SS-OCT) effectively imaged Barrett's oesophagus (BE) features in 16 unsedated patients, demonstrating good patient toleration and the ability to identify dysplastic changes.

The procedure achieved a mean capsule contact of 75% over BE and 59% longitudinal image coverage, indicating that while it can capture significant mucosal details, limited coverage may lead to sampling errors for focal pathologies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tethered capsule en face optical coherence tomography for imaging Barrett's oesophagus in unsedated patients. Liang, K., Ahsen, OO., Murphy, A., et al.[2022]

In a study involving 14 patients with Barrett's esophagus, atypical glands found under irregular mucosal patterns on OCT were present in 75% of neoplasia cases, indicating a strong association with dysplasia and potential markers for cancer development.

The study utilized 74 OCT datasets correlated with biopsy results, revealing that the absence of mucosal layering and specific surface signal patterns were also observed in both neoplasia and nondysplastic Barrett's esophagus, highlighting the diagnostic potential of OCT in assessing Barrett's esophagus.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Barrett's esophagus and dysplasia with ultrahigh-speed volumetric en face and cross-sectional optical coherence tomography. Ahsen, OO., Liang, K., Lee, HC., et al.[2020]

A new swallowable tethered capsule OCT endomicroscopy (TCE) device can capture high-resolution images of the esophagus, potentially serving as a screening tool for identifying patients with Barrett's esophagus and related dysplasia.

The development of an automated algorithm for analyzing OCT-TCE data enhances the efficiency of characterizing the esophageal wall, providing detailed contact and tissue maps that can improve the imaging process during clinical studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. Ughi, GJ., Gora, MJ., Swager, AF., et al.[2020]

A study involving 14 patients with Barrett's adenocarcinoma showed that optical coherence tomography (OCT) can accurately image buried Barrett's mucosa, achieving an overall accuracy of 85.7% in identifying the mucosal structures before surgical intervention.

OCT imaging demonstrated high specificity (100%) and positive predictive value (100%) for detecting the buried mucosa, suggesting it could enhance the effectiveness of endoscopic submucosal dissection (ESD) in removing potentially malignant areas, although it struggled to differentiate between dysplastic and non-dysplastic glands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of optical coherence tomography for the evaluation of Barrett's mucosa buried underneath esophageal squamous epithelium. Hatta, W., Uno, K., Koike, T., et al.[2022]

Tethered capsule endomicroscopy (TCE) is a safe and effective method for obtaining high-resolution images of the esophagus in patients with Barrett's esophagus, with 93.7% of participants successfully completing the procedure and high-quality images obtained.

The imaging results from TCE showed a strong correlation with traditional endoscopic findings, indicating that TCE can be a reliable tool for screening and monitoring Barrett's esophagus, and it can be administered by non-expert personnel in a multi-center setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. Dong, J., Grant, C., Vuong, B., et al.[2023]

The study demonstrated that volumetric laser endomicroscopy (VLE) for guiding biopsies in patients with Barrett's esophagus is safe, with no adverse events reported during the procedure involving 22 participants.

VLE-guided biopsy showed high accuracy in diagnosing tissue, achieving 100% accuracy for corrected VLE post-marking images compared to histopathology, indicating its potential to improve biopsy site selection and reduce diagnostic uncertainty.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. Suter, MJ., Gora, MJ., Lauwers, GY., et al.[2021]

In a study involving 1,000 patients with Barrett's esophagus, volumetric laser endomicroscopy (VLE) identified concerning tissue areas not visible with standard white light endoscopy in 59% of cases, significantly enhancing diagnostic capabilities.

VLE improved the neoplasia diagnostic yield by 55% compared to standard care and increased detection rates by 700% in patients without prior therapy, demonstrating its effectiveness as a tool for guiding tissue acquisition and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. Smith, MS., Cash, B., Konda, V., et al.[2022]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03830801

Pilot Study for OCT Guided in Vivo Laser Capture ... The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic ...

2. tearneylab.mgh.harvard.edu tearneylab.mgh.harvard.edu/wp-content/uploads/2025/03/PW2024_Fang-Hou_IVLCM-1.pdf

OCT tethered capsule endomicroscopy targeted laser ... ➢ IVLCM can capture biopsy from the esophagus in vivo. ➢ Sufficient DNA material can be extracted for genomic analysis. ➢ The average IVLCM procedure time ...

3. withpower.com withpower.com/trial/phase-barrett-esophagus-11-2017-7836c

OCT-Guided Tissue Sampling for Barrett's Esophagus Trial Overview The study tests a new device called IVLCM tethered capsule that captures high-resolution images of the esophagus to identify abnormal tissue in ...

4. ancora.ai ancora.ai/en/details/NCT03830801

IVLCM: Pilot Study for OCT Guided In Vivo Laser Capture ... IVLCM: Pilot Study for OCT Guided In Vivo Laser Capture Microdissection for Assessing the Prognosis of Barrett's Esophagus. Interventional.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8715859/

Feasibility and safety of tethered capsule endomicroscopy ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) in a multi- ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33549871/

Feasibility and Safety of Tethered Capsule ... Here, we demonstrate and evaluate the feasibility and safety of TCE and a portable OCT imaging system in patients with Barrett's esophagus (BE) ...