NCT03589443

Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Phase I In-vivo Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: University of Michigan · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Barrett Esophagus

Interventions

Type	Name	Description
DRUG	Multiplexed heptapeptides	Heptapeptides QRH and KSP

Timeline

• Start date: 2018-05-10
• Primary completion: 2019-02-04
• Completion: 2019-02-04
• First posted: 2018-07-17
• Last updated: 2019-08-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study