Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Study Overview
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Brief Summary
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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.

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

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Drug: Multiplexed heptapeptides


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Multiplexed heptapeptides<br>QRH & KSP sprayed onto area of interest and imaged before and after application | Drug: Multiplexed heptapeptides<br>* Heptapeptides QRH and KSP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validate the binding of the peptides using the SFE | 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 | 1 year | 

Secondary Outcome Measures

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