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

• ClinicalTrials.gov Identifier: NCT01630798
• Recruitment Status: Completed
• First Posted: June 28, 2012
• Last Update Posted: October 8, 2015
• Sponsor: University of Michigan
• Information provided by (Responsible Party): Missy Tuck, University of Michigan

Study Description

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" 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.

Condition or disease	Intervention/treatment	Phase
Barrett's Esophagus	Drug: GI heptapeptide	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 60 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract
• Study Start Date: July 2012
• Actual Primary Completion Date: September 2013
• Actual Study Completion Date: September 2013

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 100 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

United States, Michigan

University of Michigan

Ann Arbor, Michigan, United States, 48109

Sponsors and Collaborators

University of Michigan

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Joshi BP, Duan X, Kwon RS, Piraka C, Elmunzer BJ, Lu S, Rabinsky EF, Beer DG, Appelman HD, Owens SR, Kuick R, Doguchi N, Turgeon DK, Wang TD. Multimodal endoscope can quantify wide-field fluorescence detection of Barrett's neoplasia. Endoscopy. 2016 Feb;48(2):A1-A13. doi: 10.1055/s-0034-1392803. Epub 2015 Oct 1.

• Responsible Party: Missy Tuck, Project Manager, University of Michigan
• ClinicalTrials.gov Identifier: NCT01630798
• Other Study ID Numbers: HUM00062875
• First Posted: June 28, 2012
• Last Update Posted: October 8, 2015
• Last Verified: October 2015

Keywords provided by Missy Tuck, University of Michigan:

barrett's esophgus; High grade dysplasia; Esophageal adenocarcinoma

Additional relevant MeSH terms:

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