Expired Study
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Houston, Texas 77007


Purpose:

Primary Aim: (1) To collect data to develop algorithms to distinguish between normal and abnormal dysplastic tissue. Secondary Aims: 1. To compare esophageal fluorescence images to standard endoscopic white light images and pathologic analysis of biopsied tissue. 2. To compare esophageal reflectance images to standard endoscopic white light images and pathologic analysis of biopsied tissue. 3. To analyze images to determine which type of optical information (or combination) thereof yields the most diagnostically useful data.


Study summary:

Detection Procedures for Dysplasia and Cancer: Because dysplasia is usually not visible on a routine endoscopy, the common way to check the status of Barrett's esophagus is to collect a series of random biopsies. However, this method leaves most of the esophagus untested, and it may not detect dysplasia or early cancer. Because of this, there is a need for procedures that can detect dysplasia or cancer in a minimally invasive way (causing the smallest damage possible). The Imaging Probe: The imaging probe being used in this study is flexible and small (about the size of a needle). It has a camera on the end, which takes detailed pictures of the esophagus tissue. It will be threaded through the endoscope (a tube-shaped instrument) during the endoscopy procedure. Study Participation: If you agree to take part in this study, your esophagus will be rinsed, sprayed with a contrast agent (dye), and the imaging probe will be inserted through the endoscope. The probe will look for an area of abnormal tissue and will image that area. A biopsy will then be taken of the area as part of your standard of care biopsies. This procedure (imaging and a biopsy) will be repeated in up to five areas of your esophagus. Each sample of tissue will be smaller than a pencil eraser. All biopsies taken during this imaging will be part of your routine standard of care. No additional biopsies will be taken as part of this study. After the imaging is performed, the remaining 3 routine biopsies (each the same size as the other biopsies above) will be collected from your esophagus during your routine endoscopy exam. To perform an esophagus biopsy, a small amount of esophagus tissue is removed with a wire-shaped device that is inserted into the endoscope. It is considered routine to have 4 samples of tissue removed (1 from each of the 4 walls of the esophagus). You will be under general anesthesia for the endoscopy exam. You will not be informed of the imaging results; however, you will be informed of the pathology results of all tissue that is removed from your esophagus. Length of Study: After all of the biopsies and imaging are over, the probe will be removed and your participation in the study will be complete. You will be contacted by the study coordinator 2 to 5 days after your procedure to check on any side effects you may be experiencing. You will be given contact information for the coordinator and the PI to call about any side effects over the next 30 days. After 30 days you will receive one final phone call to check on any problems or side effects you may have experienced. This is an investigational study. The imaging probe is not FDA approved or commercially available. The M. D. Anderson Institutional Review Board (IRB) has authorized the use of the imaging probe for research only. The IRB is a committee made up of doctors, researchers, and members of the community. The IRB is responsible for protecting the participants involved in research studies and making sure all research is done in a safe and ethical manner. Up to 40 patients will take part in this study. All will be enrolled at M. D. Anderson.


Criteria:

Inclusion Criteria: - Patients with known Barrett's esophagus or Barrett's with dysplasia that are scheduled for routine surveillance endoscopy. - Signed informed consent. - Greater than or equal to 18 years old Exclusion Criteria: - Subjects who are unfit for standard upper endoscopy


NCT ID:

NCT00755625


Primary Contact:

Principal Investigator
Sharmila Anandasabapathy, MD
UT MD Anderson Cancer Center


Backup Contact:

N/A


Location Contact:

Houston, Texas 77007
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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