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NCT03589443 · ClinicalTrials.gov registry record · Phase 1
Study of Multiplexed Heptapeptides for Detection of Neoplasia in the Esophagus
A Phase 1 study, sponsored by University of Michigan.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT03589443: Completed Phase 1 study, sponsored by University of Michigan.
NCT03589443 is a Phase 1 study that has completed, run by University of Michigan. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03589443, a Phase 1 study, has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 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) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in the esophagus for use as novel imaging agents to guide endoscopic biopsy or endoscopic mucosal resection (EMR). This Phase 1 study will be used to provide early evidence of efficacy for the topical application of a panel of two peptides that bind to molecular targets that are specific for esophageal dysplasia. A panel is needed because cancer in the esophagus is genetically heterogeneous. The study will look at peptide binding in subjects with known or suspected Barrett's esophagus.
Primary Outcome
The binding of the fluorescent-labeled peptides (QRH-882260 and KSP-910638G) that bind to EGFR and HER2 using an SFE molecular imaging system (SFE) determined using the tumor-to-background ratio for fluorescence intensities
Interventions
- DRUG Multiplexed heptapeptides
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2018-05-10 |
| Est. Completion | 2019-02-04 |
| Phase | Phase 1 |
What the finished NCT03589443 record still lists
NCT03589443 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 1 intervention - of which Multiplexed heptapeptides is the first listed.
NCT03589443 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03589443 about?
NCT03589443 is a clinical study titled "Study of Multiplexed Heptapeptides 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) multiplexed imaging system. This study will combine the use of fluorescent-labeled peptides that bind specifically to pre-cancerous mucosa in...
What is the current status of trial NCT03589443?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2018-05-10. Estimated completion is 2019-02-04.
What interventions are being tested in trial NCT03589443?
The interventions under investigation include: Multiplexed heptapeptides (DRUG).
Who is sponsoring clinical trial NCT03589443?
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 NCT03589443's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 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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