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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Missy Tuck, University of Michigan
ClinicalTrials.gov Identifier:
NCT01630798
First received: June 26, 2012
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Barrett's Esophagus
Drug: GI heptapeptide
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Phase 1B In-Vivo Esophageal Protocol for Detection of Neoplasia in the Digestive Tract

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • validate binding of the fluorescent-labeled peptide to esophageal neopla [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

    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.



Enrollment: 60
Study Start Date: July 2012
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01630798

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

No publications provided

Responsible Party: Missy Tuck, Project Manager, University of Michigan
ClinicalTrials.gov Identifier: NCT01630798     History of Changes
Other Study ID Numbers: HUM00062875
Study First Received: June 26, 2012
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Michigan:
barrett's esophgus
High grade dysplasia
Esophageal adenocarcinoma

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Digestive System Abnormalities
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases

ClinicalTrials.gov processed this record on July 10, 2014