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NCT06440408 · ClinicalTrials.gov registry record · Phase 1
Calculating Wall Shear Stress in Infant Pulmonary Veins
A Phase 1 study of Pulmonary Vein Stenosis, sponsored by Children's Hospital of Philadelphia.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06440408: Recruiting Phase 1 study of Pulmonary Vein Stenosis, sponsored by Children's Hospital of Philadelphia.
NCT06440408 is a Phase 1 study of Pulmonary Vein Stenosis that is actively recruiting participants, run by Children's Hospital of Philadelphia. The registered enrollment target is 20 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06440408, a Phase 1 study of Pulmonary Vein Stenosis, is actively recruiting participants, sponsored by Children's Hospital of Philadelphia.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause. The investigators think patients who develop PVS have an increased Wall Shear Stress (WSS) level in the pulmonary veins, which is the force placed on the walls of the veins. This study will determine if WSS can be calculated in the pulmonary veins of infants using Ferumoxytol enhanced Cardiac Magnetic Resonance Imaging (FcMRI). If possible, the investigators aim to use FcMRI to better screen patients at risk of PVS and to help guide therapy in patients with PVS.
Primary Outcome
WSS (dyn/cm2) will be reported in each pulmonary vein using multiple modalities with data from the cMRI. This includes computational fluid dynamics, 4D-Flow and 4\*Mu\*v/r, where Mu is the viscosity of blood, r is the vessel radius, and v is the average velocity of blood.
Conditions Studied
Interventions
- DRUG Ferumoxytol
Study Locations (1)
Pennsylvania
- Children's Hospital of Philadelphia - Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2024-09-30 |
| Est. Completion | 2027-03 |
| Phase | Phase 1 |
What NCT06440408 shows while recruiting
NCT06440408 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% lower).
The record links to 1 condition, with Pulmonary Vein Stenosis appearing as the primary indexed condition, and to 1 intervention - of which Ferumoxytol is the first listed.
NCT06440408 reports a single indexed study location in Pennsylvania.
Frequently Asked Questions
What is clinical trial NCT06440408 about?
NCT06440408 is a clinical study titled "Calculating Wall Shear Stress in Infant Pulmonary Veins". The purpose of this study is to better understand pediatric pulmonary vein stenosis (PVS), which is the narrowing of blood vessels that connect the lungs to the heart. PVS is a life-threatening disease without a clear cause. The investigators think patients who develop PVS have an increased Wall She...
What is the current status of trial NCT06440408?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 20 participants. The study started on 2024-09-30. Estimated completion is 2027-03.
What conditions does trial NCT06440408 study?
This clinical trial studies the following conditions: Pulmonary Vein Stenosis.
What interventions are being tested in trial NCT06440408?
The interventions under investigation include: Ferumoxytol (DRUG).
Who is sponsoring clinical trial NCT06440408?
This trial is sponsored by Children's Hospital of Philadelphia, which has 431 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06440408 being conducted?
This trial has 1 study location across Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06440408's enrollment target sits among peer trials
20 1630th of 2000 higher than 285 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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