Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Phase 1

Completed

• Conditions: Barrett Esophagus
• Interventions: Drug: Multiplexed heptapeptides

• Registration Number: NCT03589443
• Lead Sponsor: University of Michigan

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-10
• Study First Submitted: 2018-06-21
• Study First Submitted QC: 2018-07-04
• Study First Posted: 2018-07-17
• Primary Completion: 2019-02-04
• Study Completion: 2019-02-04
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-02
• Last Update Posted: 2019-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Multiplexed heptapeptides	Multiplexed heptapeptides	QRH \& KSP sprayed onto area of interest and imaged before and after application

Primary Outcome Measures

Name	Time	Method
Validate the binding of the peptides using the SFE	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 Outcome Measures

Name	Time	Method
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)	1 year	One aspect of feasibility will be shown by examining the SNR of the images collected.
Use of the SFE to detect QRH and KSP via tumor-to-background ratio	1 year	One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
Use of the SFE to detect QRH and KSP via contrast	1 year	One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.

Trial Locations

Locations (1)

University of Michigan Hospital; 🇺🇸 Ann Arbor, Michigan, United States