Placental Lesions in Fetal Growth Restrictions

NCT04839185 | Completed Early Phase 1 Results FDA Drug

• 5 other identifiers: 2019-1432A532860SMPH/OBSTET & GYNECOL1U01HD087216-01Protocol ver: 04-06-2020
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study is to develop imaging methods to diagnose placental injury in pregnancies diagnosed with fetal growth restriction (FGR). Investigators are doing this research because the use of IV iron, followed by a Magnetic resonance imaging (MRI), may help detect injury in the placenta. The IV iron, ferumoxytol, is an iron preparation used for treatment of iron deficiency anemia. It is given in hospital setting under close medical attention. Ferumoxytol(FE) is FDA approved for some uses, but in pregnant women, its use as a MRI contrast is investigational.

Conditions

Fetal Growth Retardation

Outcome Measures

Primary Outcomes (3)

• Number of Participants for Which Intervillous Placental Blood is Detected

  Intervillous Placental Blood will be detected by Magnetic resonance imaging (MRI). The patient will receive the first 60-minute MRI within 1-15 hours after completion of the ferumoxytol infusion.

  up to 1 week

• Number of Participant for Which Placental Lesions Are Detected

  Placental lesion will be detected by Magnetic resonance imaging (MRI). The patient will receive the first 60-minute MRI within 1-15 hours after completion of the ferumoxytol infusion.

  up to 1 week

• Number of Participants for Which Macrophage at the Implementation Site Are Detected

  FE-MRI (ferumoxytol- magnetic resonance imaging) will be used first time as a contrast agent to generate for the 3D high-resolution MRI maps of macrophages at the maternal-fetal interface (MFI) in real time in vivo.

  up to 1 week

Study Arms (1)

Diagnostic: Ferumoxytol MRI

OTHER

The participant will receive an infusion of an iron supplement, ferumoxytol, followed by a same day MRI scan and then a second MRI scan 3-5 days later.

Drug: Ferumoxytol infusion; Procedure: MRI scan

Interventions

Ferumoxytol infusion DRUG

Ferumoxytol will be administered intravenously, by infusion, over 30 minutes. It will be used a contrast agent for MRI imaging to detect placental lesions in fetal growth restriction. Dose will be 255 mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Ferumoxytol/Feraheme will be administered only once, in one infusion of 255 mg to each subject.

Also known as: Feraheme

Diagnostic: Ferumoxytol MRI

MRI scan PROCEDURE

The MRI scanning procedure will last for approximately 60 minutes.

Diagnostic: Ferumoxytol MRI

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Pregravid Body Mass Index (BMI) 18.5-39.9 kg/M2
• Women with singleton pregnancies
• Ultrasound confirmed pregnancy dating prior to 14 weeks gestation
• Gestational age of 27 0/7 - 32 6/7 weeks at FGR diagnosis based on standard clinical criteria: Either estimated fetal weight (EFW) less than 10 percentile OR abdominal circumference less than 10th percentile

You may not qualify if:

• Diagnosis of preeclampsia at FGR diagnosis
• Gestational Diabetes Mellitus or type I/II Diabetes Mellitus
• Known fetal chromosome abnormality, structural malformation or syndromes in current pregnancy
• Known fetal viral infection syndrome
• Alcohol/drug use in current pregnancy
• History of sickle cell anemia, sickle cell trait or other inherited anemia with risk of iron overload
• Contraindications to MRI (such as claustrophobia, metallic implant, etc.) based on MRI Screening
• Participation in other interventional clinical trials, including those with other investigational agents not included in this trial, within 30 days of the start of this trial and throughout the duration of this trial
• Any physical or psychological symptom, based on the clinical judgment of the study physician that would make a participant unsuitable for the study.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator

Study Sites (1)

University of Wisconsin-Madison

Madison, Wisconsin, 53715, United States

Location

MeSH Terms

Conditions

Fetal Growth Retardation

Interventions

Ferrosoferric Oxide; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Growth Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ferric Compounds; Iron Compounds; Inorganic Chemicals; Ferrous Compounds; Minerals; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

There is not enough data to conclusively categorize placental lesions due to a lack of comparative normative placental data or targeted biopsy, which would require advanced novel methodology to match locations in imaging data with pathology data.

Results Point of Contact

• Title: Dinesh Shah, MD
• Organization: UW School of Medicine and Public Health

dmshah@wisc.edu

608-417-6099

Study Officials

• Dinesh Shah, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 9, 2021
• Study Start: April 15, 2021
• Primary Completion: October 6, 2021
• Study Completion: October 6, 2021
• Last Updated: August 22, 2025
• Results First Posted: May 12, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)