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

NCT03852576 | Terminated Phase 1 DMC FDA Drug

• 1 other identifier: HUM00158121
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 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) 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.

Conditions

Barrett Esophagus

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (1)

Esophagus sprayed with KSP/QRH dimer

EXPERIMENTAL

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

Drug: KSP/QRH dimer

Interventions

KSP/QRH dimer DRUG

KSP-QRH-E3-IRDye800 (Peptide 919288G)

Esophagus sprayed with KSP/QRH dimer

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• 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.

  PMID: 35299273 DERIVED

MeSH Terms

Conditions

Barrett Esophagus

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Danielle K Turgeon, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

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: February 20, 2019
• First Posted: February 25, 2019
• Study Start: May 9, 2019
• Primary Completion: November 18, 2020
• Study Completion: November 18, 2020
• Last Updated: November 22, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share

Locations

US (1)