Phase 1B Study of KSP/QRH Dimer 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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

Official Title
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Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus

Conditions
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Barrett Esophagus

Intervention / Treatment
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* Drug: KSP/QRH dimer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has known or suspected Barrett's esophagus Scheduled for a clinically-indicated, upper endoscopy Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities) Age 18 to 100 years Willing and able to sign informed consent Exclusion Criteria: Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives Subjects on 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: Esophagus sprayed with KSP/QRH dimer<br>Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe | Drug: KSP/QRH dimer<br>* KSP-QRH-E3-IRDye800 (Peptide 919288G)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binding of KSP/QRH dimer to EGFR and HER2 | Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background | During and immediately after procedure, generally no more than 2 hours | 
| SFE ability to detect dimer by SNR | SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR) | During and immediately after procedure, generally no more than 2 hours | 
| SFE ability to detect dimer by fluorescence T/B ratio | SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio | During and immediately after procedure, generally no more than 2 hours | 
| SFE ability to detect dimer with contrast | SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast | During and immediately after procedure, generally no more than 2 hours |