OCT-Guided Tissue Sampling for Barrett's Esophagus

(IVLCM Trial)

Overseen By Elizabeth Biddle, RN

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

Trial Summary

What is the purpose of this trial?

The investigators have developed a new technology, termed in-vivo laser capture microdissection (IVLCM), that addresses the limitations of endoscopic biopsy for screening for BE and provides targeted genomic profiling of aberrant tissue for more precise prediction of EAC risk. The device is a tethered capsule endomicroscope (TCE) that implements optical coherence tomography (OCT) to grab 10-mm-resolution, cross-sectional microscopic images of the entire esophagus after the capsule is swallowed. This OCT-based TCE technology is used in unsedated patients to visualize images of BE and dysplastic BE. During the IVLCM procedure, TCE images of abnormal BE tissue are identified in real time and selectively adhered onto the device. When the capsule is removed from the patient, these tissues, targeted based on their abnormal OCT morphology, are sent for genomic analysis. By enabling the precise isolation of aberrant esophageal tissues using a swallowable capsule, this technology has the potential to solve the major problems that currently prohibit adequate BE screening and prevention of Esophageal Adenocarcinoma EAC.

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 data supports the effectiveness of the treatment IVLCM tethered capsule, In-Vivo Laser Capture Microdissection, Tethered Capsule Endomicroscope for Barrett's Esophagus?

Research shows that tethered capsule endomicroscopy (TCE) is safe and feasible for imaging Barrett's Esophagus, providing high-resolution images that can help identify abnormal areas needing further examination. Additionally, volumetric laser endomicroscopy (VLE) has been shown to improve the detection of abnormal tissue by 55% and increase neoplasia detection by 700% compared to standard methods, suggesting that these imaging techniques can enhance the management of Barrett's Esophagus. ^{1 2 3 4 5}

Is OCT-guided tissue sampling for Barrett's Esophagus safe for humans?

Research shows that tethered capsule endomicroscopy (TCE), which uses optical coherence tomography (OCT) for imaging, is generally safe for humans. Studies involving patients with Barrett's Esophagus have demonstrated the feasibility and safety of this method, with no significant safety concerns reported. ^{1 2 3 4 6}

How is the OCT-Guided Tissue Sampling for Barrett's Esophagus treatment different from other treatments?

This treatment uses a swallowable capsule with optical coherence tomography (OCT) to capture detailed images of the esophagus, allowing for non-invasive, high-resolution imaging of Barrett's esophagus without the need for sedation or traditional endoscopy. It is unique because it provides a comprehensive view of the esophageal tissue, potentially improving early detection and monitoring of the condition. ^{1 2 3 4 7}

Research Team

Gary Tearney, MD., PhD

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Patients must be able to give informed consent.

I am over 18 years old.

Exclusion Criteria

You are pregnant.

I have a history of bleeding disorders.

I am taking blood thinners or NSAIDs currently.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

References

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

Automated segmentation and characterization of esophageal wall in vivo by tethered capsule optical coherence tomography endomicroscopy. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Tethered capsule en face optical coherence tomography for imaging Barrett's oesophagus in unsedated patients. [2022]

3. Germany pubmed.ncbi.nlm.nih.gov

Assessment of Barrett's esophagus and dysplasia with ultrahigh-speed volumetric en face and cross-sectional optical coherence tomography. [2020]

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

Feasibility and Safety of Tethered Capsule Endomicroscopy in Patients With Barrett's Esophagus in a Multi-Center Study. [2023]

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

Volumetric laser endomicroscopy and its application to Barrett's esophagus: results from a 1,000 patient registry. [2022]

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

Esophageal-guided biopsy with volumetric laser endomicroscopy and laser cautery marking: a pilot clinical study. [2021]

7. Australia pubmed.ncbi.nlm.nih.gov

Feasibility of optical coherence tomography for the evaluation of Barrett's mucosa buried underneath esophageal squamous epithelium. [2022]