Skip to main content
OpenTrials
Completed

NCT Number: NCT03589443

Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

The overall aim of this feasibility study is to develop new technologies for improved detection of Barrett's neoplasia using the scanning fiber endoscope(SFE) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Known or suspected Barrett's esophagus
  • Scheduled for a clinically-indicated upper endoscopy
  • Medically cleared for the procedure
  • Willing and able to sign informed consent

Exclusion criteria

  • Known allergy or negative reaction to the near infrared fluorophores Cy5, li-cor IRDye800CW, or derivatives
  • One active chemotherapy or radiation treatment
  • Pregnant or trying to conceive

Treatment and study plan

Multiplexed heptapeptides

Drug

Heptapeptides QRH and KSP

Primary outcomes

  1. Validate the binding of the peptides using the SFE

    Time frame: 1 year

    The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using an SFE molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities

Secondary outcomes

  1. Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)

    Time frame: 1 year

    One aspect of feasibility will be shown by examining the SNR of the images collected.

  2. Use of the SFE to detect QRH and KSP via tumor-to-background ratio

    Time frame: 1 year

    One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.

  3. Use of the SFE to detect QRH and KSP via contrast

    Time frame: 1 year

    One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jul 17, 2018
Registry last updated
Aug 5, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.