Neoplasms

Digestive System Diseases

All Conditions

Barrett Esophagus

Precancerous Conditions

Esophageal Diseases

Gastrointestinal Diseases

SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

Imaging of the esophagus using SECM probe and system.

SECM Probe

Guillermo Tearney, MD, PhD

The study is being done to test the feasibility and tolerability of a SECM imaging probe in patients with Barrett's Esophagus (BE).

Subjects will undergo SECM probe imaging while they are under conscious sedation. Spiral SECM imaging will be performed continuously over a pre-determined length. Patients will later be asked for their feedback.

Subjects with a previous diagnosis of Barrett's Esophagus will be recruited in the study and undergo SECM probe imaging while using conscious sedation, pulse oximetry and blood pressure monitoring. The probe will be inserted the predetermined required distance in the esophagus using a guide wire.

Once the SECM imaging probe is in place, spiral SECM image data will be continuously collected over a pre-determined length (approximately 5cm).

Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe

Pilot Study to Image the Esophagus Using a SECM Probe

We were monitoring the number of participants able to tolerate the procedure. All six participating subjects have been asked for a feedback about tolerability of the procedure using a specific tolerability questionnaire.

Massachusetts General Hospital

Professor of Pathology

The adverse events were collected systematically for this study. The definition of adverse events is the same as clinicaltrials.gov definition.

SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

SECM Probe: Imaging of the esophagus using SECM probe and system.

No adverse events has been reported.

SECM Probe Imaging

SECM probe will be guided to a pre-determined length in the esophagus and spiral imaging will be performed using the SECM Imaging System.

SECM Probe: Imaging of the esophagus using SECM probe and system.

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Guillermo Tearney, PI

All six study participants completed the study and the obtained data has been analyzed

Number of Participants With Tolerability of the Procedure

Overall Study

Skin and Connective Tissue Diseases

Symptoms and General Pathology

Pigmentation Disorders

Nevus, Pigmented

Nevus

Skin Diseases

Melanoma

Nevi and Melanomas

Neoplasms by Histologic Type

The SECM skin imaging procedure will be very similar to that by the FDA approved RCM devices. First, the skin lesion (such as a mole) will be identified on a forearm of the subject. The lesion will be imaged first with a dermatoscope, and then with the SECM device. A dermatoscope is a hand-held device used for the visual observation of the epidermis. It is a superior surface contact microscope used to examine skin lesions.

Consented Participants will be asked to allow their forearm to be imaged by the dermatoscope on the same skin/lesions as a control comparison. We will be trying to image pigmented skin/lesions present on the forearm. This will be followed by imaging using the SECM Skin imaging device

SECM Skin Imaging

Guillermo Tearney, M.D, PhD.

The aim of this study is to evaluate the imaging performance of Spectrally Encoded Confocal Microscopy (SECM) for imaging human skin and skin diseases.

SECM provides an order of magnitude faster imaging speed than conventional confocal microscopy devices. The investigators have previously utilized the SECM technology for imaging large area of human esophagus in vivo. They have also developed endoscopic capsule devices which have been used to safely image over 60 human subjects, healthy volunteers and subjects with eosinophilic esophagitis, using SECM technology, rapidly.

When used for skin imaging, SECM can provide real-time three-dimensional confocal imaging and significantly reduce the imaging time. While SECM has been successfully used for imaging human esophagus in vivo, its utility in skin imaging needs to be tested in a new pilot study. The investigators will be taking images with a dermatoscope as well. This will the control to compare the experimental images to, as the dermatoscope is the standard of care diagnostic tool for dermatologists.

Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy

The quality, resolution and depth of the images will be reviewed by the PI. This is a qualitative analysis to determine the feasibility of the device, the parameters mentioned will be compared to correlative data obtained from the dermatoscope control. Unit measurements are not available.

Principal Investigator - MD, PhD, FACC, FCAP, FNAI

Blood and Lymph Conditions

Immune System Diseases

Rare Diseases

Esophagitis

Eosinophilic Esophagitis

Gastroenteritis

Eosinophilia

Leukocyte Disorders

Hematologic Diseases

Hypersensitivity

Hypersensitivity, Immediate

Eosinophilic Gastroenteritis

Subject will swallow the SECM capsule and the imaging of the esophagus will be performed using a SECM optical system

Subjects will swallow a SECM capsule and the SECM imaging will be performed

SECM capsule

Anita Chung, RN

Nitasha Bhat, MD

Elizabeth Biddle, RN

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is \~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.

Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.

A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.

The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.

Imaging of the Esophagus Using a SECM Capsule

comparing SECM imaging of the esophagus obtained with a SECM capsule to histopathology.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe	NCT02210039	Barrett's Esoph...	SECM Probe	18 Years -	Massachusetts General Hospital
Pilot Study of Imaging Human Skin With High-Speed Spectrally Encoded Confocal Microscopy	NCT04566302	Pigmented Lesio... Pigmented Skin ... Pigmented Moles Skin Lesion	SECM Skin Imagi...	18 Years -	Massachusetts General Hospital
Using Spectrally Encoded Confocal Microscopy (SECM) to Visualise the Esophagus Using an SECM Probe	NCT02210039	Barrett's Esoph...	SECM Probe	18 Years -	Massachusetts General Hospital
Imaging of the Esophagus Using a SECM Capsule	NCT03546660	Eosinophilic Es... Barrett Esophag...	SECM capsule	12 Years -	Massachusetts General Hospital

Spots Global Cancer Trial Database for secm

Every month we try and update this database with for secm 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 secm

Every month we try and update this database with for secm 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 secm 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.