Barrett Esophagus
Conditions
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) 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.
Interventions
DRUGKSP/QRH dimer
KSP-QRH-E3-IRDye800 (Peptide 919288G)
Sponsors
University of Michigan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Binding of KSP/QRH dimer to EGFR and HER2 | During and immediately after procedure, generally no more than 2 hours | Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background |
| SFE ability to detect dimer by SNR | During and immediately after procedure, generally no more than 2 hours | SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR) |
| SFE ability to detect dimer by fluorescence T/B ratio | During and immediately after procedure, generally no more than 2 hours | 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 |
| SFE ability to detect dimer with contrast | During and immediately after procedure, generally no more than 2 hours | SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast |
Countries
United States
Outcome results
None listed