A In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract (NTR 1B)

October 7, 2015 updated by: Missy Tuck, University of Michigan

A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

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" 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 1b study. This means that although the investigators have applied the peptide to 25 people in our first research study, the investigators still need to learn more about "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 the peptide "glows" well and if the investigators can take pictures of the areas that do glow.

This is a research study of the peptide and our ability to see it "light up or fluoresce". Being in this study and applying this peptide won't change how your biopsies are taken nor how your endoscopy is done.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects with Barrett's Esophagus or esophageal adenocarcinoma with or without confirmed Barrett's Esophagus
  • Subjects who are scheduled for a clinically-indicated upper endoscopic evaluation and/or intervention (e.g. esophagogastroduodenoscopy (EGD) with biopsies)
  • All subjects who are medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) who meet the inclusion/exclusion will be included. Standard practice guidelines for safely proceeding with the procedure will be sufficient for our study
  • Adults aged 18 years to 100
  • Willing and able to sign informed consent

Exclusion Criteria:

  • Subjects with known allergy or negative reaction to fluorescein or derivatives
  • Subjects who have had an esophagectomy
  • Subjects who are also prepped for colonoscopy with the EGD
  • Subjects on active chemotherapy or radiation treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Application of peptide
Drug: GI heptapeptide
Investigational Agent Name: GI heptapeptide, Linear, 7 amino acid peptide sequence ASYNYDA with a 5-FITC tag and NH2 terminus. Investigational Agent Administration (see SOP in Appendix C) ASYNYDA-GGGSK-(5-FITC)-NH2 0.8 mg lyophilized powder per single-use amber vial Lyophilized powder reconstituted with 5 ml of 0.9% NaCl Final 100 µM concentration for single, one-time topical application Entire 5 ml volume (100 uM concentration) will be sprayed topically onto esophagus by the nurse/physician during the procedure through a standard endoscopy spray catheter (Olympus Medical, Tokyo Japan, PW-5V-1)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
validate binding of the fluorescent-labeled peptide to esophageal neopla
Time Frame: 1.5 years

The overall aim of this research project is to develop the use of fluorescent-labeled peptides that affinity bind to pre-cancerous mucosa in the digestive tract for use as an imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This particular study is a phase Ib, vaidation of efficacy of the topically applied peptide and continuing assessment of safety.

To validate binding of the fluorescent-labeled peptide to esophageal neoplasia using an Olympus FITC Endoscopic Molecular Imaging System.
1.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Danielle Kim Turgeon, M.D., University of Michigan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

June 26, 2012

First Submitted That Met QC Criteria

June 27, 2012

First Posted (Estimate)

June 28, 2012

Study Record Updates

Last Update Posted (Estimate)

October 8, 2015

Last Update Submitted That Met QC Criteria

October 7, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUM00062875

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Barrett's Esophagus

Clinical Trials on GI heptapeptide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Georgia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe