Trial Outcomes & Findings for Placental Lesions in Fetal Growth Restrictions (NCT NCT04839185)

NCT ID: NCT04839185

Last Updated: 2025-08-22

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: EARLY_PHASE1
• Target enrollment: 3 participants
• Primary outcome timeframe: up to 1 week
• Results posted on: 2025-08-22

Participant Flow

Participants were enrolled from UnityPoint Health-Meriter Hospital, April 2021 to July 2021.

Participant milestones

Measure	Diagnostic: Ferumoxytol MRI 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.
Overall Study STARTED	3
Overall Study COMPLETED	3
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Placental Lesions in Fetal Growth Restrictions

Baseline characteristics by cohort

Measure	Diagnostic: Ferumoxytol MRI n=3 Participants 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.
Age, Customized 30-39 years	2 Participants n=5 Participants
Age, Customized 40-49 years	1 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 1 week

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.

Outcome measures

Measure

Diagnostic: Ferumoxytol MRI n=3 Participants 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.

Number of Participants for Which Intervillous Placental Blood is Detected

3 Participants

PRIMARY outcome

Timeframe: up to 1 week

Population: Please see Limitations and Caveats section

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.

Outcome measures

Measure

Diagnostic: Ferumoxytol MRI n=3 Participants 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.

Number of Participant for Which Placental Lesions Are Detected

2 Participants

PRIMARY outcome

Timeframe: up to 1 week

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.

Outcome measures

Measure

Diagnostic: Ferumoxytol MRI n=3 Participants 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.

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

0 Participants

Adverse Events

Diagnostic: Ferumoxytol MRI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Diagnostic: Ferumoxytol MRI n=3 participants at risk 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. Ferumoxytol infusion: 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. MRI scan: The MRI scanning procedure will last for approximately 60 minutes.
Nervous system disorders Headache	33.3% 1/3 • Adverse Events data will be collected from when the participant signs consent through 6 week post-partum, or up to 3 months on study.
Gastrointestinal disorders Abdominal Cramp	33.3% 1/3 • Adverse Events data will be collected from when the participant signs consent through 6 week post-partum, or up to 3 months on study.
Infections and infestations Upper Respiratory Viral Infection	33.3% 1/3 • Adverse Events data will be collected from when the participant signs consent through 6 week post-partum, or up to 3 months on study.

Additional Information

Dinesh Shah, MD

UW School of Medicine and Public Health

Phone: 608-417-6099

Email: dmshah@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place