Back to resultsPhase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Primary Purpose
Barrett Esophagus
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
KSP/QRH dimer
Sponsored by
About this trial
This is an interventional diagnostic trial for Barrett Esophagus
Eligibility Criteria
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
Sites / Locations
- University of Michigan
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Esophagus sprayed with KSP/QRH dimer
Arm Description
Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe
Outcomes
Primary Outcome Measures
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
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)
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
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
Secondary Outcome Measures
Full Information
NCT ID
NCT03852576
First Posted
February 20, 2019
Last Updated
November 17, 2022
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT03852576
Brief Title
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
Official Title
Phase 1B In-vivo Study of KSP/QRH Heptapeptide Dimer for Detection of Neoplasia in the Esophagus
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Study had to be terminated for lack of dimer and inability to produce more at this time.
Study Start Date
May 9, 2019 (Actual)
Primary Completion Date
November 18, 2020 (Actual)
Study Completion Date
November 18, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Barrett Esophagus
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
38 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Esophagus sprayed with KSP/QRH dimer
Arm Type
Experimental
Arm Description
Area of interest in subject's esophagus sprayed with KSP/QRH dimer and imaged with the SFE probe
Intervention Type
Drug
Intervention Name(s)
KSP/QRH dimer
Intervention Description
KSP-QRH-E3-IRDye800 (Peptide 919288G)
Primary Outcome Measure Information:
Title
Binding of KSP/QRH dimer to EGFR and HER2
Description
Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
Time Frame
During and immediately after procedure, generally no more than 2 hours
Title
SFE ability to detect dimer by SNR
Description
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using signal-to-noise ratio (SNR)
Time Frame
During and immediately after procedure, generally no more than 2 hours
Title
SFE ability to detect dimer by fluorescence T/B ratio
Description
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
Time Frame
During and immediately after procedure, generally no more than 2 hours
Title
SFE ability to detect dimer with contrast
Description
SFE (scanning fiber endoscope) imaging system will be used to image the dimer on the area of interest using contrast
Time Frame
During and immediately after procedure, generally no more than 2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Danielle K Turgeon, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
Citations:
PubMed Identifier
35299273
Citation
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.
Results Reference
derived
Learn more about this trial
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
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