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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 is a Phase 1 study that was terminated before completion, run by University of Michigan. The registered enrollment target is 38 participants.

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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.

Interventions

  • DRUG KSP/QRH dimer

Trial Details

FieldValue
Enrollment Target 38 participants
Start Date 2019-05-09
Est. Completion 2020-11-18
Phase Phase 1

Sponsor

University of Michigan

1,327 total trials

What the Registry Record Tells You About NCT03852576

The ClinicalTrials.gov registry entry for NCT03852576 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which KSP/QRH dimer is the first listed.

NCT03852576 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.