Recruiting
Phase 1

Observational Study

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT06440408

Conditions

Pulmonary Vein Stenosis

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Interventions

Ferumoxytol

Study Details

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.

Conditions

Pulmonary Vein Stenosis

Study ID

NCT06440408

Start date

Sep 30, 2024

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Ferumoxytol enhanced cMRI

A one time dose of Ferumoxytol will be administered prior to the cMRI in order to enhance the images. A dose of 4 mg/kg (max dose 510 mg) administered at a concentration of 8 mg/mL (in saline) will be used for this study. If the volume being administered is less than 6 mL, this is diluted with 3 mL of normal saline prior to administration. The drug is given over 15 minutes intravenously through a central or peripheral line. The drug is given at least 15 minutes prior to cardiac imaging.

Interventions

Ferumoxytol

Ferumoxytol will be used as a contrast agent for the cMRI

Primary outcome measure

  • Wall Shear Stress level in infant pulmonary veins using cMRI [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Aug 5, 2026

Last verified

Aug, 2026

Keywords

  • Cardiac Magnetic Resonance Imaging
  • Wall Shear Stress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-08-05.