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

Phase 1

Terminated

• Conditions: Barrett Esophagus
• Interventions: Drug: KSP/QRH dimer

• Registration Number: NCT03852576
• Lead Sponsor: University of Michigan

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) 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-20
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-25
• Study Start: 2019-05-09
• Primary Completion: 2020-11-18
• Study Completion: 2020-11-18
• Status Verified: 2022-11
• Last Update Submitted: 2022-11-17
• Last Update Posted: 2022-11-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 38

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Esophagus sprayed with KSP/QRH dimer	KSP/QRH dimer	Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States