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Study Summary
No. 2006-0100:.......Gastrointestinal......Manoop Bhutani......Gastroenterology/Hepatology and Nutrition
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Study Summary Title
Study Summary
Number:
2006-0100
Study Title:Ex vivo Reflectance and Fluorescence Confocal Imaging With Molecular Contrast Agents for Detection of Dysplasia in Barrett's Esophagus: A Pilot Study
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Physician New Patient Referral
Name:Manoop BhutaniPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Gastroenterology/Hepatology and NutritionReferring MD
Call:
800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-794-5073
Contact us about clinical trials
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General Information
Disease Group:GastrointestinalSupported By:N/A
Phase of Study:N/AReturn
Visit:
Patients with Barrett's esophagus typically undergo endoscopy at 3 month-3 year
intervals depending upon the grade of their dysplasia.
Treatment
Agents:
NoneHome Care:This study does not allow for any treatment to be given at home.
Treatment Loc:Independent Multicenter Arrangements
Estimated
Length of Stay
in Houston:
Participation in this study will not increase the patient's length or frequency
of hospitalization.
Description/
Intervention:
The goal of this laboratory research study is to look at a new technology used
to help check for normal and abnormal tissue from inside the esophagus.
Researchers would like to be able to link their findings with changes found on
examination of tissue and cells by a pathologist. This may help in finding
precancerous and cancerous tissue in the esophagus.
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Study Objectives / Outcomes
The hypothesis of this lab protocol is that topical application of the anti-EGFR and anti-telomerase fluorescent contrast agent followed by optical imaging will yield images that reflect spatial variations in EGFR and telomerase expression and will correlate with the presence of esophageal precancer as assessed by histopathology. To test this hypothesis we will:

1. Obtain specimens of Barrett's mucosa from patients undergoing routine surveillance endoscopy for Barrett's esophagus. Patients with Barrett's esophagus typically undergo endoscopy at 3 month-3 year intervals depending upon the grade of their dysplasia. In the routine clinical care of patients with Barrett's esophagus, 4 biopsies are taken every 1-2 cm throughout the length of Barrett's esophagus. These will be submitted to the pathology department as part of the patient's routine clinical care and will not be used for research. For purposes of the study, an additional biopsy will be taken from each level of Barrett's esophagus, plus 1-2 biopsies of normal squamous mucosa.

2. Immediately after obtaining the study specimens, low-resolution optical images will be obtained of the samples using a multispectral digital microscope (MDM) which records the light remitted from the tissue surface. High resolution optical images will then be obtained from suspicious areas using a confocal microscope. The spectral characteristics of the suspicious lesions will be measured using a spectroscopy system.

3. Immediately after imaging, spectroscopy measurements, and biopsy, the contrast agent(s) will be applied to the epithelial surface of the tissue.

4. After 30 minutes, the tissue will be rinsed with PBS and low resolution optical images will be obtained using a multispectral digital microscope (MDM), which records the light remitted from the tissue surface. High resolution optical images will be obtained from suspicious areas using a confocal microscope. The spectral characteristics of the lesions will be measured using a spectroscopy system.
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Study Status Information
Study Activation / Registration Date:07/11/2006
IRB Review and Approval Date:04/05/2006
Study Type:Other
Recruitment Status:Closed
Projected Accrual:80
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:1) Patients with known Barrett's esophagus or Barrett's with dysplasia that are scheduled for routine surveillance endoscopy will be offered participation.

2) Patients must sign an informed consent indicating awareness of the investigational nature of this study.

Exclusion Criteria:1) Inability to provide informed consent.

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Links
Registration Number: Not Applicable Clinical Trial

Other Links:
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Results


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