Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Completed · Phase 1

Conditions studied: Barrett Esophagus

In brief

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.

Key facts

Study ID

NCT03589443

Run by

University of Michigan

People needed

27

Starts

2018-05-10

Expected to finish

2019-02-04

Last updated by the study team

2019-08-05

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Michigan Hospital — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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