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

Barrett Esophagus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03852576
• Other study ID #: HUM00158121
• Status: Terminated
• Phase: Phase 1
• Start date: May 9, 2019
• Est. completion date: November 18, 2020

Study information

• Verified date: November 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 38
• Est. completion date: November 18, 2020
• Est. primary completion date: November 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Barrett Esophagus

Intervention

Drug:
• KSP/QRH dimer
KSP-QRH-E3-IRDye800 (Peptide 919288G)

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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