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
1 other identifier
interventional
27
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started May 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2018
CompletedFirst Submitted
Initial submission to the registry
June 21, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 4, 2019
CompletedAugust 5, 2019
August 1, 2019
9 months
June 21, 2018
August 2, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Use of the SFE to detect QRH and KSP via signal to noise ratio (SNR)
1 year
Use of the SFE to detect QRH and KSP via tumor-to-background ratio
1 year
Use of the SFE to detect QRH and KSP via contrast
1 year
Study Arms (1)
Multiplexed heptapeptides
EXPERIMENTALQRH \& KSP sprayed onto area of interest and imaged before and after application
Interventions
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan Hospital
Ann Arbor, Michigan, 48109, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Internal Medicine
Study Record Dates
First Submitted
June 21, 2018
First Posted
July 17, 2018
Study Start
May 10, 2018
Primary Completion
February 4, 2019
Study Completion
February 4, 2019
Last Updated
August 5, 2019
Record last verified: 2019-08