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Pulmonary Vein StenosisPhase 1PVS-WSSNCT06440408

Calculating Wall Shear Stress in Infant Pulmonary Veins

A Phase 1 study testing Ferumoxytol in people with Pulmonary Vein Stenosis, run by Children's Hospital of Philadelphia at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 18 years
Conditions the study is for
Pulmonary Vein Stenosis
What is being tested?
Ferumoxytol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
30 Sep 2024to Jun 2028
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ryan Callahan, MD contact

267-426-2957

callahanr2@chop.edu

United States1 site, 1 recruiting

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

    Ryan Callahan, MD, 267-426-2957, callahanr2@chop.edu

    Recruiting

Other trials in United States

About this study

Official title: Calculating Wall Shear Stress in Pulmonary Veins of Infants Using Cardiac Magnetic Resonance Imaging: A Pilot Study

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.

Read the detailed description

Background:

The mechanism of pediatric intraluminal pulmonary vein stenosis (PVS) remains unknown. It is hypothesized that elevated wall shear stress (WSS) as a result of excessive pulmonary blood flow (left to right shunts) and/or pulmonary vein distortion from surrounding anatomy contributes to the neo-intimal proliferation. Calculating WSS in pediatric pulmonary veins using ferumoxytol enhanced cardiac magnetic resonance (FcMRI) has not been reported and would represent a novel method of evaluation.

Objectives:

The primary objective is to determine the feasibility of calculating WSS in infant pulmonary veins using FcMRI. The secondary objective is to determine the magnitude and variability of WSS in pulmonary veins among high-risk patients and normal controls.

Study Design:

Prospective, interventional, single center, feasibility study

Setting/Participants:

Single center study at The Children's Hospital of Philadelphia. High-risk infants (n = 10) will include two groups of patients; (1) infants with moderate to severe bronchopulmonary dysplasia (BPD) and (2) infants with postoperative repair of total anomalous pulmonary venous connection (TAPVC). Group 1 participants will be infants who are undergoing an MRI as part of clinical care for other issues (i.e., MRI brain for hypoxic ischemia encephalopathy), with the research FcMRI being performed following the clinical care MRI. Group 2 participants will be infants who are undergoing FcMRI as part of clinical care. Controls (n = 10) will be pediatric patients without intracardiac defects who are undergoing FcMRI as part of clinical care (i.e., evaluation of anomalous coronary, aortopathy, vascular ring).

Study Procedures, Interventions and Measures:

Participants will undergo FcMRI and have the WSS calculated in each pulmonary vein (right upper, right lower, left upper, left lower) using several methodologies. Patients will be followed for 12 months following cMRI monitoring for a new diagnosis of PVS.

Being tested
Ferumoxytol
Keywords
Cardiac Magnetic Resonance Imaging, Wall Shear Stress
Medical subject headings
Stenosis, Pulmonary Vein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FerumoxytolDrug

    Also called Feraheme

    Ferumoxytol will be used as a contrast agent for the cMRI

Study groups in NCT06440408
Study groupRoleWhat they receive
Ferumoxytol enhanced cMRIExperimentalA 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.
Receives: Drug: Ferumoxytol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Wall Shear Stress level in infant pulmonary veins using cMRI

    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.

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2024
  2. Study start30 Sep 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06440408
Sponsor's protocol ID
IRB 23-021612
Acronym
PVS-WSS
Status last verified
Aug 2026
First submitted
24 May 2024
Last updated
5 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hammer PE, McEnaney K, Callahan R, Baird CW, Hoganson DM, Jenkins KJ. The Role of Elevated Wall Shear Stress in Progression of Pulmonary Vein Stenosis: Evidence from Two Case Studies. Children (Basel). 2021 Aug 25;8(9):729. doi: 10.3390/children8090729.

    PubMed 34572161

  • Misra S, Fu AA, Misra KD, Glockner JF, Mukhopadhyay D. Wall shear stress measurement using phase contrast magnetic resonance imaging with phase contrast magnetic resonance angiography in arteriovenous polytetrafluoroethylene grafts. Angiology. 2009 Aug-Sep;60(4):441-7. doi: 10.1177/0003319709335908. Epub 2009 Jul 21.

    PubMed 19625275

  • Kamada H, Nakamura M, Ota H, Higuchi S, Takase K. Blood flow analysis with computational fluid dynamics and 4D-flow MRI for vascular diseases. J Cardiol. 2022 Nov;80(5):386-396. doi: 10.1016/j.jjcc.2022.05.007. Epub 2022 Jun 17.

    PubMed 35718672

  • Callahan R, Gauvreau K, Marshall AC, Sena LM, Baird CW, Ireland CM, McEnaney K, Bjornlund EC, Mendonca JT, Jenkins KJ. Outcomes in Establishing Individual Vessel Patency for Pediatric Pulmonary Vein Stenosis. Children (Basel). 2021 Mar 10;8(3):210. doi: 10.3390/children8030210.

    PubMed 33802089

  • Nguyen KL, Yoshida T, Kathuria-Prakash N, Zaki IH, Varallyay CG, Semple SI, Saouaf R, Rigsby CK, Stoumpos S, Whitehead KK, Griffin LM, Saloner D, Hope MD, Prince MR, Fogel MA, Schiebler ML, Roditi GH, Radjenovic A, Newby DE, Neuwelt EA, Bashir MR, Hu P, Finn JP. Multicenter Safety and Practice for Off-Label Diagnostic Use of Ferumoxytol in MRI. Radiology. 2019 Dec;293(3):554-564. doi: 10.1148/radiol.2019190477. Epub 2019 Oct 22.

    PubMed 31638489

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Ferumoxytol in people with Pulmonary Vein Stenosis, run by Children's Hospital of Philadelphia at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ryan Callahan, MD (267-426-2957, callahanr2@chop.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Wall Shear Stress level in infant pulmonary veins using cMRI (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06440408, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2026.

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