Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

Subject will swallow the OFDI capsule, marking will be performed by making superficial cautery marks on the tissue. This will be followed by imaging using the OFDI Imaging system.

Marking and imaging of the esophagus using the OFDI Capsule and system.

OFDI Capsule Marking

Guillermo Tearney, MD, PhD

The purpose of this research is to test the feasibility, sensitivity, and specificity of the marking Optical Frequency Domain Imaging (OFDI) capsule for diagnosing Barrett's Esophagus (BE).

A total of 130 subjects scheduled to undergo esophagogastroduodenoscopy (EGD) will be asked to swallow the OFDI capsule while being unsedated. The capsule is attached to a tether that allows the capsule operator to navigate the capsule as it progresses down the esophagus using natural propulsion called peristalsis as well as to bring it back up to pulled out of the mouth when the procedure is done.

OFDI real-time images will be used for targeting of the region to be marked. Once in position, two cautery marks will be made to only the superficial layers of the esophageal mucosa. Following cautery marking, the capsule will be lowered in the esophagus and marked regions of interest will be reimaged for confirmation of the placement of potential cautery marks.

Immediately following the completion of the experimental procedure, the standard of care with the performance of the surveillance endoscopy will be performed. Images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule

The images obtained by the OFDI capsule will be compared to the images obtained by the clinical endoscopy and histology.

National Institutes of Health (NIH)

National Cancer Institute (NCI)

Massachusetts General Hospital

Principal Investigator

Imaging of the esophagus with a compact OFDI system and distal scanning catheter

Experimental OFDI Imaging

Elizabeth Biddle, RN

Anita Chung, RN

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.

Ten healthy volunteer subjects and ten volunteers with a previous diagnosis of Barrett's Esophagus (BE) will be enrolled in the study.

The capsule is attached to a string-like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using peristalsis.

Images of the esophagus will be acquired in real time to be analyzed later.

Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System

Pilot Study for TCE (Tethered Capsule Endomicroscopy) Imaging of the Esophagus Using an OFDI (Optical Frequency Domain Imaging) Capsule With a Compact Imaging System

Images obtained from the CIS will be assessed for quality and compared to images acquired from the previous imaging system

Professor of Pathology

Skin and Connective Tissue Diseases

Skin Neoplasms

Skin Diseases

Optical Frequency Domain Imaging (OFDI) will be used to look at non melanoma skin cancer (NMSC) lesion(s).

OFDI

Benjamin Vakoc, PhD

The purpose of this research study is to find out if a non-invasive imaging device called Optical Frequency Domain Imaging (OFDI) can help doctors to see the tissue and blood vessels that are related to non-melanoma skin cancers. OFDI was designed to see microscopic details of your skin without needing to use any invasive techniques such as surgery or biopsy.

Non-melanoma skin cancer (NMSC) is the most common cancer in the United States, with more than 750,000 diagnosed patients treated every year. Its prevalence and incidence have significantly increased over the past two decades and it has been estimated that 20% of all Americans will develop this type of cancer during their lifetime (Neville et al., 2007). Biopsy and surgical resection of NMSC can result in tissue mutilation and scaring. Therefore, there is a need for new imaging technologies that can be used to non-invasively guide biopsy and surgery.

Optical Frequency Domain Imaging (OFDI) is a second-generation imaging implementation of optical coherence tomography (OCT) developed at the Wellman Center. OFDI provides high-resolution three-dimensional imaging in tissue. It uses an interferometric depth-sectioning technique and employs a near-infrared light source. Through analysis of phase information in the recorded signal. OFDI can detect blood vessels within tissues and tumors. Importantly, OFDI-based vascular imaging can be performed without the need for exogenous contrast agents, making it relatively easy to deploy in clinical settings.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule	NCT02422433	Barrett's Esoph...	OFDI Capsule Ma...	18 Years -	Massachusetts General Hospital
Surveillance and Image-Guided Biopsy of the Esophagus Using an OFDI Capsule	NCT02422433	Barrett's Esoph...	OFDI Capsule Ma...	18 Years -	Massachusetts General Hospital
Pilot Study for TCE Imaging of the Esophagus Using an OFDI Capsule With a Compact Imaging System	NCT02947971	Barrett's Esoph...	Experimental OF...	18 Years - 70 Years	Massachusetts General Hospital
Optical Frequency Domain Imaging for Non-melanoma Skin Cancers	NCT01662713	Non-Melanoma Sk...	OFDI	18 Years - 80 Years	Massachusetts General Hospital

Spots Global Cancer Trial Database for ofdi

Every month we try and update this database with for ofdi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ofdi

Every month we try and update this database with for ofdi cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ofdi cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.