Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

NCT01391208 | Completed Phase 1 DMC

• 1 other identifier: U54CA136429
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Barrett's Esophagus with High Grade Dysplasia; Esophageal adenocarcinoma

Outcome Measures

Primary Outcomes (1)

• Safety of peptide application

  The study will test the safety of administering this agent to human subjects. Prior to the EGD,subjects will have baseline blood work, urinanalysis via dipstick and urine pregnancy test. Labs for CBC w/ platets, chemistries and liver function tests and (COMP panel). These labs will be to compare to post-procedure levels for any possible side effects. These tests will be repeated 24 hours post peptide application and as needed weekly until labs resolve to normal ranges.

  0 (baseline) and 24 hours

Study Arms (1)

peptide application

NO INTERVENTION

Drug: GI heptapeptide

Interventions

GI heptapeptide DRUG

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.

peptide application

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects who have biopsy-proven or suspected high-grade dysplasia 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).
• Adults aged 18 years to 100 years old.
• Willing and able to sign informed consent.
• The effects of the 5-FITC-labeled peptide on the developing human fetus are unknown. For this reason, women of child-bearing potential must have a negative pregnancy test on the day of the procedure to receiving the 5-FITC-labeled peptide agent or be post-menopausal. Post-menopausal women are defined as post-hysterectomy, or over 40 and at least 18 months without menses and not on birth-control.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Barrett Esophagus; Adenocarcinoma Of Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Project manager

Study Record Dates

• First Submitted: July 6, 2011
• First Posted: July 11, 2011
• Study Start: February 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)