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

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to develop new optical imaging tools to help doctors detect and diagnose diseases in the digestive system without causing harm. During their usual endoscopy or colonoscopy, participants will have a few extra tissue samples taken to advance these imaging techniques. Individuals scheduled for an elective endoscopy or colonoscopy might be suitable for this trial. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future diagnostic methods.

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 prior data suggests that this optical imaging device is safe for gastrointestinal use?

Research has shown that optical imaging devices are generally safe for people. Studies have found that these devices provide accurate and reliable results and are safe for use in the human esophagus. This suggests they are also well-tolerated in other parts of the digestive system.

Although some imaging methods can be invasive, they offer live, detailed images crucial for diagnosis, often making the benefits outweigh the risks. Participants can feel reassured about the safety of these devices, as testing in people has not revealed major issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the optical imaging device for gastrointestinal disorders because it offers a new way to enhance diagnosis. Unlike traditional methods that rely solely on standard endoscopy and histology, this approach aims to develop advanced imaging techniques that could improve the visualization of gastrointestinal tissues. By collecting additional biopsies and utilizing them to refine imaging practices, this method could lead to more accurate and earlier detection of disorders, potentially improving patient outcomes.

What evidence suggests that this optical imaging device is effective for gastrointestinal disorders?

Research has shown that optical imaging techniques effectively detect early signs of digestive system problems. For instance, one study found that magnifying NBI, a specific type of optical imaging, accurately diagnosed conditions like early stomach cancer and gastric intestinal metaplasia over 90% of the time. Another study involving more than 4,000 patients found that these techniques increased the detection rate of pre-cancerous growths by 3.5% compared to standard methods. Optical imaging is also valued for being real-time, cost-effective, and free of harmful radiation. In this trial, participants will help develop novel optical imaging technologies, which promise to improve the diagnosis and treatment of digestive disorders. ^{1 6 7 8 9}

Who Is on the Research Team?

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12563889/

Optical Imaging Technologies and Clinical Applications in ... For gastric intestinal metaplasia and early gastric cancer, magnifying NBI achieves diagnostic accuracies exceeding 90% and is guideline- ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4941161/

The use of optical imaging techniques in ... A meta-analysis of five studies, comprising 4422 patients demonstrated a 3.5% (95% CI 0.9% to 6.1%) improvement in ADR as compared with standard ...

3. withpower.com withpower.com/trial/phase-gastrointestinal-diseases-2-2016-75d89

Optical Imaging 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 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1043661825000374

Optical imaging guidance in oncologic surgery and ... Major advantages of OI include real-time application during the treatment procedure, cost-effectiveness, portability, lack of ionizing radiation, simultaneous ...

5. febs.onlinelibrary.wiley.com febs.onlinelibrary.wiley.com/doi/10.1002/1878-0261.12792

Advances in optical gastrointestinal endoscopy: a technical ... We provide a technical review of optical endoscopic imaging technologies for GI cancer screening and surveillance.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4146926/

Advanced imaging and visualization in gastrointestinal ... Studies done until now in the human esophagus have shown that the multimodal imaging device is safe to use and provides accurate and reproducible data.

7. fda.gov fda.gov/media/184943/download

Developing Drugs for Optical Imaging ... system, lymphatic system, or gastrointestinal. 50 tract. 51. 52 ... 3 Optical imaging drugs are generally used with an optical imaging device.

8. mdpi.com mdpi.com/2076-3417/10/19/6865

Endoscopic Optical Imaging Technologies and Devices for ... Even though these imaging modalities like endoscopy are invasive in some cases, they provide live and high-resolution imaging (in the micrometer range). In ...

9. nature.com nature.com/articles/s41467-022-35259-5

Optical-resolution functional gastrointestinal photoacoustic ... We report the development of a miniature, high-resolution photoacoustic endoscope for gastrointestinal imaging in vivo by using a laser ultrasound sensor.