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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
27
Heptapeptides QRH and KSP
University of Michigan Hospital
Ann Arbor, Michigan, United States
Validate the binding of the peptides using the SFE
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
Time frame: 1 year
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
One aspect of feasibility will be shown by examining the SNR of the images collected.
Time frame: 1 year
Use of the SFE to detect QRH and KSP via tumor-to-background ratio
One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
Time frame: 1 year
Use of the SFE to detect QRH and KSP via contrast
One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.
Time frame: 1 year
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