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NCT03852576 · ClinicalTrials.gov registry record · Phase 1
Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus
A Phase 1 study, sponsored by University of Michigan.
- Terminated
- Registry status
- Phase 1
- Development phase
- 38
- Enrollment target
NCT03852576: Clinical Trial Phase 1 study, sponsored by University of Michigan.
NCT03852576 is a Phase 1 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 38 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03852576, a Phase 1 study, was terminated before completion, sponsored by University of Michigan.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 38 participants
- Enrollment target
Study 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.
Primary Outcome
Validation of the dimer to EGFR and HER2 using target-to-background ratio of the suspicious region compared to the background
Interventions
- DRUG KSP/QRH dimer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2019-05-09 |
| Est. Completion | 2020-11-18 |
| Phase | Phase 1 |
Why NCT03852576 stopped before completion
NCT03852576 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (37% lower).
The record links to 0 conditions, and to 1 intervention - of which KSP/QRH dimer is the first listed.
NCT03852576 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03852576 about?
NCT03852576 is a clinical study titled "Phase 1B Study of KSP/QRH Dimer for Detection of Neoplasia in the Esophagus". 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...
What is the current status of trial NCT03852576?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 38 participants. The study started on 2019-05-09. Estimated completion is 2020-11-18.
What interventions are being tested in trial NCT03852576?
The interventions under investigation include: KSP/QRH dimer (DRUG).
Who is sponsoring clinical trial NCT03852576?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03852576's enrollment target sits among peer trials
38 1197th of 2000 higher than 797 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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