NCT06440408

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
10mo left

Started Sep 2024

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Sep 2024Mar 2027

First Submitted

Initial submission to the registry

May 24, 2024

Completed
10 days until next milestone

First Posted

Study publicly available on registry

June 3, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

August 20, 2025

Status Verified

August 1, 2025

Enrollment Period

1.9 years

First QC Date

May 24, 2024

Last Update Submit

August 19, 2025

Conditions

Pulmonary Vein Stenosis

Keywords

Cardiac Magnetic Resonance ImagingWall Shear Stress

Outcome Measures

Primary Outcomes (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.

    12 months

Study Arms (1)

Ferumoxytol enhanced cMRI

EXPERIMENTAL

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.

Drug: Ferumoxytol

Interventions

FerumoxytolDRUG

Ferumoxytol will be used as a contrast agent for the cMRI

Also known as: Feraheme
Ferumoxytol enhanced cMRI

Eligibility Criteria

AgeUp to 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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 subjects 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.
  • 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).
  • Congenital heart disease with single ventricle physiology.
  • Parents/guardians or subjects 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Related Publications (5)

  • 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.

    PMID: 34572161BACKGROUND

  • 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.

    PMID: 19625275BACKGROUND

  • 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.

    PMID: 35718672BACKGROUND

  • 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.

    PMID: 33802089BACKGROUND

  • 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.

    PMID: 31638489BACKGROUND

MeSH Terms

Conditions

Stenosis, Pulmonary Vein

Interventions

Ferrosoferric Oxide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Ferric CompoundsIron CompoundsInorganic ChemicalsFerrous CompoundsMinerals

Study Officials

  • Ryan Callahan, MD

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ryan Callahan, MD

CONTACT

267-426-2957callahanr2@chop.edu

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pediatrics

Study Record Dates

First Submitted

May 24, 2024

First Posted

June 3, 2024

Study Start

September 30, 2024

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

March 1, 2027

Last Updated

August 20, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)