Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-09

Study Completion Date

2020-11-18

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.

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Detailed Description

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Conditions

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Barrett Esophagus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Esophagus sprayed with KSP/QRH dimer

Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe

Group Type EXPERIMENTAL

KSP/QRH dimer

Intervention Type DRUG

KSP-QRH-E3-IRDye800 (Peptide 919288G)

Interventions

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KSP/QRH dimer

KSP-QRH-E3-IRDye800 (Peptide 919288G)

Intervention Type DRUG

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No