Optical Imaging for Gastrointestinal Disorders

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: Others

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

Compensation: Varies

Number of Visits: 1

200 Participants Needed

Trial Summary

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

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the optical imaging treatment for gastrointestinal disorders?

Optical imaging techniques have shown promise in detecting early lesions in the gastrointestinal tract, which can lead to more effective and less invasive treatments. These techniques help doctors see subtle changes in the tissue, allowing for real-time diagnosis and potentially improving outcomes for patients with gastrointestinal issues. ^{1 2 3 4 5}

Is optical imaging for gastrointestinal disorders safe for humans?

The research articles provided do not contain specific safety data for optical imaging devices used for gastrointestinal disorders, as they focus on other procedures like colonoscopy and CT colonography. ^{6 7 8 9 10}

How does optical imaging differ from other treatments for gastrointestinal disorders?

Optical imaging for gastrointestinal disorders is unique because it allows doctors to see detailed images of the inside of the digestive tract in real-time, helping to detect early signs of disease without needing to take tissue samples. This 'optical biopsy' can provide immediate information about the condition of the tissue, unlike traditional methods that require waiting for lab results. ^{1 4 11 12 13}

What is the purpose of this trial?

To develop novel optical imaging technologies for use as a non-destructive and minimally invasive tool for detection and diagnosis of various diseases that affect the gastrointestinal system.

Research Team

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

This trial is for individuals scheduled for an elective esophagoduodenoscopy and/or colonoscopy, typically procedures to look inside the stomach and colon. It's not open to those who don't meet the Massachusetts General Hospital (MGH) endoscopy department's standard care criteria.

Inclusion Criteria

I am scheduled for a scope exam of my esophagus and/or colon.

Exclusion Criteria

According to standard of care at MGH endoscopy department.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure and Sample Collection

Participants undergo elective esophagogastroduodenoscopy or colonoscopy with biopsy for optical imaging of ex vivo GI specimens

1 day

1 visit (in-person)

Analysis

Offline analysis of the samples is performed, correlating optical imaging findings with pathology findings

Up to 1 year

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

Treatment Details

Interventions

• Optical imaging device

Trial Overview The study is testing a new optical imaging device designed to image gastrointestinal biopsy samples. The goal is to see if this technology can help diagnose diseases of the gastrointestinal system without being too invasive or damaging tissue.

Participant Groups

Group I: Development of novel optical imaging technologies Experimental Treatment 1 Intervention

Consented participants will allow their endoscopist to collect 3 additional biopsies from the participants. These biopsies will be used to develop our imaging techniques at our lab. We will use the standard of care histology images from the endoscopy procedure as a control comparison.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Findings from Research

The AGREE classification system for adverse events in gastrointestinal (GI) endoscopy was validated and showed an 80% agreement in severity perception among endoscopists, nurses, and patients, indicating its reliability.

The AGREE classification correlated significantly with the established ASGE classification, and was deemed simple, reproducible, and useful by 96% of experts, suggesting it can enhance the standardization and quality assurance of AE reporting in GI endoscopy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel classification for adverse events in GI endoscopy: the AGREE classification. Nass, KJ., Zwager, LW., van der Vlugt, M., et al.[2023]

A large-scale survey of 147,439 computed tomographic colonography (CTC) examinations found a very low risk of adverse events, with colorectal perforations occurring in only 0.014% of cases and no reported deaths.

The risk of colorectal perforation was significantly lower during screening procedures (0.003%) compared to preoperative staging (0.028%), and 81% of perforation cases did not require emergency surgery, indicating that CTC is a safe option for colorectal cancer screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. Nagata, K., Takabayashi, K., Yasuda, T., et al.[2022]

In a study of 17,067 CT colonography examinations across 50 centers, only 0.08% of patients experienced potentially serious adverse events, indicating a very low incidence of complications associated with the procedure.

Among the adverse events, there were nine perforations, with a symptomatic perforation rate of just 0.03%, suggesting that while complications can occur, they are rare and often asymptomatic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. Burling, D., Halligan, S., Slater, A., et al.[2016]

The novel narrow band imaging (NBI) system demonstrated high sensitivity (89%) and specificity (78%) for diagnosing normal mucosa or mild gastritis in a pilot study of 47 patients undergoing upper endoscopy.

NBI also showed promising results for identifying specific gastric conditions, with 75% sensitivity and 88% specificity for H. pylori gastritis, and 80% sensitivity and 100% specificity for intestinal metaplasia, indicating its potential as a reliable diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between narrow band imaging and nonneoplastic gastric pathology: a pilot feasibility trial. Bansal, A., Ulusarac, O., Mathur, S., et al.[2008]

References

1. England pubmed.ncbi.nlm.nih.gov

The use of optical imaging techniques in the gastrointestinal tract. [2020]

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

Developments in optical imaging for gastrointestinal surgery. [2018]

3. England pubmed.ncbi.nlm.nih.gov

New imaging techniques and opportunities in endoscopy. [2021]

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

Advances in optical gastrointestinal endoscopy: a technical review. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Clinically Available Optical Imaging Technologies in Endoscopic Lesion Detection: Current Status and Future Perspective. [2023]

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

Adverse events Following Computed Tomographic Colonography compared to Optical Colonoscopy in the Elderly. [2022]

7. Egypt pubmed.ncbi.nlm.nih.gov

Rates of minor adverse events and health resource utilization postcolonoscopy. [2019]

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

Novel classification for adverse events in GI endoscopy: the AGREE classification. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Adverse events during CT colonography for screening, diagnosis and preoperative staging of colorectal cancer: a Japanese national survey. [2022]

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

Potentially serious adverse events at CT colonography in symptomatic patients: national survey of the United Kingdom. [2016]

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

Correlation between narrow band imaging and nonneoplastic gastric pathology: a pilot feasibility trial. [2008]

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

Scanning single fiber endoscopy: a new platform technology for integrated laser imaging, diagnosis, and future therapies. [2022]

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

Optical biopsy: a new frontier in endoscopic detection and diagnosis. [2018]