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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: Clinical Trial Phase 1 study, sponsored by Danielle Kim Turgeon.
NCT04304781 is a Phase 1 study that was terminated before completion, run by Danielle Kim Turgeon. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The fluorescence intensity will be measured by the target/background (T/B) ratio from suspicious regions of bile duct where the fluorescent-labeled peptide is administered. The intensity of the fluorescence of the abnormal tissue compared to the background tissue intensity will be analyzed using statistical analysis for significance comparing the tissue groups' mean T/B ratios.
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 |
Why NCT04304781 stopped before completion
NCT04304781 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which KSP/QRH dimer is the first listed.
NCT04304781 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04304781's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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