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New treatment option for Pulmonary Vein Stenosis
Official title Calculating Wall Shear Stress in Infant Pulmonary Veins
ClinicalTrials.gov ID: NCT06440408
What this study is testing
What is Ferumoxytol?
Ferumoxytol is an investigational medicine, being studied as a potential treatment for pulmonary vein stenosis.
Also referred to as Feraheme.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 18
You may be able to join if
- Normal (Controls) people 1. Males or Females less than 18 years of age.
- Weight \> 3 kg.
- Undergoing cMRI with ferumoxytol as part of clinical care.
- Structurally normal heart (by echocardiography) with exception of small left to right shunts, isolated valve pathology, anomalous coronary arteries...
- Parental/guardian permission (informed consent). Normal (Controls) people
You likely can't join if
- Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies...
- Parents/guardians or people who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- 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...
- Males or Females less than 12 months of age.
- Diagnosis of moderate to severe BPD (group 1) or TAPVC s/p repair (group 2).
- Weight \> 3 kg.
See the full eligibility criteria
- Normal (Controls) people 1. Males or Females less than 18 years of age.
- Weight \> 3 kg.
- Undergoing cMRI with ferumoxytol as part of clinical care.
- 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.
- Parental/guardian permission (informed consent). Normal (Controls) people
- Congenital heart disease (except small left to right shunts, isolated valve pathology, anomalous coronary arteries, extracardiac vascular anomalies such as arch anomalies).
- Parents/guardians or people who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- 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
- Males or Females less than 12 months of age.
- Diagnosis of moderate to severe BPD (group 1) or TAPVC s/p repair (group 2).
- Weight \> 3 kg.
- Undergoing non-contrast MRI for clinical reasons (group 1) or undergoing cMRI with ferumoxytol as part of clinical care (group 2).
- Parental/guardian permission (informed consent). High-Risk Subject Exclusion Criteria
- Congenital heart disease with single ventricle physiology.
- Parents/guardians or people who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures.
- Patient has a contraindication to ferumoxytol such as a known hypersensitivity to the drug, or a known diagnosis of iron overload.
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 18 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.