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Study had to be terminated for lack of dimer and inability to produce more at this time.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KSP/QRH dimer | Drug | KSP-QRH-E3-IRDye800 (Peptide 919288G) |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Danielle K Turgeon, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35299273 | Derived | 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. |
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| ID | Term |
|---|---|
| D001471 | Barrett Esophagus |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
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| D004066 |
| Digestive System Diseases |