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

Phase 1TerminatedNCT03852576

University of Michigan38 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Barrett Esophagus

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: 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

Time frame: 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

Time frame: During and immediately after procedure, generally no more than 2 hours

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

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes