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) 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.
Interventions
DRUGMultiplexed heptapeptides
Heptapeptides QRH and KSP
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
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Validate the binding of the peptides using the SFE | 1 year | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR) | 1 year | One aspect of feasibility will be shown by examining the SNR of the images collected. |
| Use of the SFE to detect QRH and KSP via tumor-to-background ratio | 1 year | One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected. |
| Use of the SFE to detect QRH and KSP via contrast | 1 year | One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected. |
Countries
United States
Outcome results
None listed