Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus

Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus

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) imaging system. This study will combine the use of a fluorescent-labeled peptide dimer that bind specifically to pre-cancerous mucosa in the esophagus for use as a novel imaging agent to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1B study will be used to provide early evidence of efficacy for the topical application of a peptide dimer that binds to molecular targets, including EGFR and HER2, that are specific for esophageal dysplasia. A dimer is needed because cancer in the esophagus is genetically heterogeneous. QRH binds specifically to Epidermal Growth Factor Receptor (EGFR), and KSP binds specifically to Human Epithelial Growth Factor Receptor (HER2). The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.

Study Overview

• Status: Terminated
• Conditions: Barrett Esophagus
• Intervention / Treatment: Drug: KSP/QRH dimer

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Has known or suspected Barrett's esophagus
• Scheduled for a clinically-indicated, upper endoscopy
• Subject is medically cleared for the procedure (e.g. washout for anticoagulants, co-morbidities)
• Age 18 to 100 years
• Willing and able to sign informed consent

Exclusion Criteria:

• Subjects with known allergy or negative reaction to the near infrared fluorophore IRDye800CW, or derivatives
• Subjects on active chemotherapy or radiation treatment
• Pregnant or trying to conceive

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Esophagus sprayed with KSP/QRH dimer; Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe	Drug: KSP/QRH dimer; KSP-QRH-E3-IRDye800 (Peptide 919288G)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binding of KSP/QRH dimer to EGFR and HER2	Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background	During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer by SNR	SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)	During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer by fluorescence T/B ratio	SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using fluorescence tumor-to-background (T/B) ratio	During and immediately after procedure, generally no more than 2 hours
SFE ability to detect dimer with contrast	SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast	During and immediately after procedure, generally no more than 2 hours

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Danielle K Turgeon, MD, University of Michigan

Publications and helpful links

General Publications

• Chen J, Jiang Y, Chang TS, Rubenstein JH, Kwon RS, Wamsteker EJ, Prabhu A, Zhao L, Appelman HD, Owens SR, Beer DG, Turgeon DK, Seibel EJ, Wang TD. Detection of Barrett's neoplasia with a near-infrared fluorescent heterodimeric peptide. Endoscopy. 2022 Dec;54(12):1198-1204. doi: 10.1055/a-1801-2406. Epub 2022 Mar 17.

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 9, 2019
• Primary Completion (ACTUAL): November 18, 2020
• Study Completion (ACTUAL): November 18, 2020

Study Registration Dates

• First Submitted: February 20, 2019
• First Submitted That Met QC Criteria: February 21, 2019
• First Posted (ACTUAL): February 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 22, 2022
• Last Update Submitted That Met QC Criteria: November 17, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Gastrointestinal Diseases; Esophageal Diseases; Precancerous Conditions; Barrett Esophagus
• Other Study ID Numbers: HUM00158121

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No