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Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

NCT01391208 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-10-11

No results posted yet for this study

Summary

You are invited to participate in a research study to develop new ways to look for abnormal areas/tissues of the esophagus. The current endoscopes used to look at the esophagus are very good, but if the area doesn't look different to the naked eye, then the endoscope can't improve on that. The investigators are looking at using special fluorescent stains in addition to special endoscopes designed to see abnormal areas that are not obvious to the naked eye. Currently specialized microscopes and fluorescent stains are used in clinical laboratories but it takes several days of processing to get results. It may be very helpful to look for areas to sample for abnormal tissue during the endoscopy procedure.

You are being asked to let us use "fluorescent peptides" with a special endoscope that allow us to "see" of your esophagus with both fluorescent and white light during your upper GI endoscopy procedure to help target your biopsies. Peptides are small chains of amino acids (the building blocks that make up proteins) linked together. Our peptide is a chain of 7 amino acids attached to a fluorescent dye called FITC (like the one used by your eye doctor).

The investigators have prepared special "fluorescent peptides", that will "glow" when a special light is used that should help us separate normal tissue from abnormal tissue. In this study, the investigators will apply the special fluorescent peptides by a spray catheter to your esophagus to help us target you biopsies. Both routine and targeted biopsies will be taken as your endoscopist feels is indicated.

This is a phase 1 study. This means that this is the first time the investigators have used this kind of "fluorescent peptide" in people. The Food and Drug Administration (FDA) has not approved this agent, but is allowing us to test it in this study. The main goal of this study is to see if there are any side effects from using the peptide. Our second goal is to see if the peptide "glows" well and if the investigators can take pictures of the areas that do glow.

This is the first test of this agent, so it won't be used to change how your biopsies are taken nor how your endoscopy is done.

Conditions

  • Barrett Esophagus
  • Esophageal Adenocarcinoma

Interventions

DRUG

GI heptapeptide

GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Chemical Formula: Ala1-Ser2-Tyr3-Asn4-Tyr5-Asp6-Ala7-Gly8- Gly9-Gly10-Ser11-Lys12 (5-FITC) -NH213.Investigational Agent Manufacturer: CPC Scientific, 1245 Reamwood Ave, Sunnyvale, CA 94089 Investigational Agent information: Lot Number: 10031701, M.W. 1577.6, 97.2% pure. Stored at -20C Yellow, lyophilized powder in single use amber vials. 5-FITC is light-sensitive, therefore stored protected from light. Manufactured under cGMP with Certificate of Analysis (COA) provided.

Sponsors & Collaborators

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391208 on ClinicalTrials.gov