Ann Arbor, Michigan 48109

  • Barrett Esophagus

Purpose:

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.


Criteria:

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


Study is Available At:


Original ID:

HUM00137993


NCT ID:

NCT03589443


Secondary ID:


Study Acronym:


Brief Title:

Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 1


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

100 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Michigan


Oversight Authority:

There was an error processing this request


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

27


Enrollment Type:

Actual


Study Dates

Start Date:May 10, 2018
Completion Date:February 4, 2019
Completion Type:Actual
Primary Completion Date:February 4, 2019
Primary Completion Type:Actual
Verification Date:August 2019
Last Changed Date:August 2, 2019
First Received Date:June 21, 2018

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Use of the SFE to detect QRH and KSP via contrast
Time Frame:1 year
Safety Issues:False
Description:One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.
Outcome Type:Secondary Outcome
Measure:Use of the SFE to detect QRH and KSP via tumor-to-background ratio
Time Frame:1 year
Safety Issues:False
Description:One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
Outcome Type:Secondary Outcome
Measure:Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
Time Frame:1 year
Safety Issues:False
Description:One aspect of feasibility will be shown by examining the SNR of the images collected.
Outcome Type:Primary Outcome
Measure:Validate the binding of the peptides using the SFE
Time Frame:1 year
Safety Issues:False
Description: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

Study Interventions

Intervention Type:Drug
Name:Multiplexed heptapeptides
Description:Heptapeptides QRH and KSP
Arm Name:Multiplexed heptapeptides

Study Arms

Study Arm Type:Experimental
Arm Name:Multiplexed heptapeptides
Description:QRH & KSP sprayed onto area of interest and imaged before and after application

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Michigan

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 31, 2021

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