Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03589443
• Other study ID #: HUM00137993
• Status: Completed
• Phase: Phase 1
• Start date: May 10, 2018
• Est. completion date: February 4, 2019

Study information

• Verified date: August 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: February 4, 2019
• Est. primary completion date: February 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Drug:
• Multiplexed heptapeptides
Heptapeptides QRH and KSP

Locations

Country	Name	City	State
United States	University of Michigan Hospital	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 year
Secondary	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.	1 year
Secondary	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.	1 year
Secondary	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.	1 year