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NCT04304781 · ClinicalTrials.gov registry record · Phase 1
Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer
A Phase 1 study, sponsored by Danielle Kim Turgeon.
- Terminated
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT04304781 is a Phase 1 study that was terminated before completion, run by Danielle Kim Turgeon. The registered enrollment target is 12 participants.
The verdict
NCT04304781, a Phase 1 study, was terminated before completion, sponsored by Danielle Kim Turgeon.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarkers of cholangiocarcinoma for use as a novel imaging agent to guide endoscopic biopsies. 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 that are specific for biliary intra-epithelial neoplasia. A dimer is needed because cancer in the biliary tract 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 having a medical condition requiring an ERCP to diagnose a potential biliary disorder. The Phase 1A first-in-human studies of safety with topical administration by ingestion of KSP/QRH dimer (HUM00141420) has been completed.
Interventions
- DRUG KSP/QRH dimer
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2020-09-22 |
| Est. Completion | 2021-12-17 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04304781
The ClinicalTrials.gov registry entry for NCT04304781 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Danielle Kim Turgeon, which has 4 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.
NCT04304781 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04304781 about?
NCT04304781 is a clinical study titled "Phase 1 In-vivo Biliary Study of KSP/QRH Heptapeptide Dimer". The overall aim of this feasibility study is to develop new technologies for improved detection of cholangiocarcinoma using the SFE-based molecular-imaging mini-cholangioscope (MC) system. This study will combine the use of a fluorescent-labeled peptide dimer that binds specifically to know biomarke...
What is the current status of trial NCT04304781?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2020-09-22. Estimated completion is 2021-12-17.
What interventions are being tested in trial NCT04304781?
The interventions under investigation include: KSP/QRH dimer (DRUG).
Who is sponsoring clinical trial NCT04304781?
This trial is sponsored by Danielle Kim Turgeon, which has 4 total clinical trials registered on ClinicalTrials.gov.
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