NCT06440408 Calculating Wall Shear Stress in Infant Pulmonary Veins
| NCT ID | NCT06440408 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Children's Hospital of Philadelphia |
| Condition | Pulmonary Vein Stenosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 20 participants in total. It began in 2024-09-30 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Normal (Controls) Subjects Inclusion Criteria 1. Males or Females less than 18 years of age. 2. Weight \> 3 kg. 3. Undergoing cMRI with ferumoxytol as part of clinical care. 4. Structurally normal heart (by echocardiography) with exception of small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies. 5. Parental/guardian permission (informed consent). Normal (Controls) Subjects Exclusion Criteria 1. Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies). 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient not receiving ferumoxytol as part of their cMRI due to a known hypersensitivity to the drug, or a known diagnosis of iron overload. High-Risk Subject Inclusion Criteria 1. Males or Females less than 12 months of age. 2. Diagnosis of severe BPD (group 1) or TAPVC s/p repair (group 2). 3. Weight \> 3 kg. 4. Receiving respiratory support with an invasive airway (tracheostomy or endotracheal tube) (group 1 only). 5. Undergoing cMRI with ferumoxytol as part of clinical care (group 2 only). 6. Parental/guardian permission (informed consent). High-Risk Subject Exclusion Criteria 1. Congenital heart disease with single ventricle physiology. 2. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures. 3. Patient has a contraindication to ferumoxytol or any intravenous iron product such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.
Contact & Investigator
Ryan Callahan, MD
PRINCIPAL INVESTIGATOR
Children's Hospital of Philadelphia
Frequently Asked Questions
Who can join the NCT06440408 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Pulmonary Vein Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06440408 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06440408 currently recruiting?
Yes, NCT06440408 is actively recruiting participants. Contact the research team at callahanr2@chop.edu for enrollment information.
Where is the NCT06440408 trial being conducted?
This trial is being conducted at Philadelphia, United States.
Who is sponsoring the NCT06440408 clinical trial?
NCT06440408 is sponsored by Children's Hospital of Philadelphia. The principal investigator is Ryan Callahan, MD at Children's Hospital of Philadelphia. The trial plans to enroll 20 participants.