Back to resultsStudy of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
Primary Purpose
Barrett Esophagus
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Multiplexed heptapeptides
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility 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
Sites / Locations
- University of Michigan Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Multiplexed heptapeptides
Arm Description
QRH & KSP sprayed onto area of interest and imaged before and after application
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03589443
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
May 10, 2018 (Actual)
Primary Completion Date
February 4, 2019 (Actual)
Study Completion Date
February 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
27 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Multiplexed heptapeptides
Arm Type
Experimental
Arm Description
QRH & KSP sprayed onto area of interest and imaged before and after application
Intervention Type
Drug
Intervention Name(s)
Multiplexed heptapeptides
Intervention Description
Heptapeptides QRH and KSP
Primary Outcome Measure Information:
Title
Validate the binding of the peptides using the SFE
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
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
Description
One aspect of feasibility will be shown by examining the SNR of the images collected.
Time Frame
1 year
Title
Use of the SFE to detect QRH and KSP via tumor-to-background ratio
Description
One aspect of feasibility will be shown by examining the tumor-to-background ratio of the images collected.
Time Frame
1 year
Title
Use of the SFE to detect QRH and KSP via contrast
Description
One aspect of feasibility will be shown by examining the contrast in the two channels in the images collected.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
University of Michigan Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
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