Fetal Growth RetardationEarly Phase 1NCT04839185
Placental Lesions in Fetal Growth Restrictions
A Early Phase 1 study testing Ferumoxytol infusion and MRI scan in people with Fetal Growth Retardation, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Fetal Growth Retardation
- What is being tested?
- Ferumoxytol infusion and MRI scan
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 6 Oct 2021
- Phase
- Early Phase 1
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53715
About this study
Official title: Detection of Placental Lesions in Fetal Growth Restriction
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.
Read the detailed description
Research Procedure Descriptions
Blood/urine collection for research Blood and urine samples are collected at the consenting visit and at the time of delivery. A total of 10 mL, of blood is collected via venipuncture along with an aliquot of a urine sample. For research visits that coincide with clinical visits, research blood samples are collected in conjunction with clinical samples, saving subjects an additional needle stick. All subjects are asked if they wish to have left over research samples banked for future unspecified research. Blood and urine samples will be analyzed to monitor relevant maternal growth factors, multiplex assays for Cytokine panel and Matrix metalloproteinases (MMPs). Urine will be tested for Shed VE-Cadherin (VE Cad).
60 minute MRI: This MRI scan will take approximately 60 minutes. Prior to entering the MR suite, subjects are screened again for MRI safety and compatibility. The MR imaging exam is expected to take approximately 60 minutes with some additional time to get subjects comfortably placed in the scanner. Subjects are made as comfortable as possible in the bore and are provided with an alarm, which allows them to get the attention of the MR technologist conducting the scan. There is a break between scans to ensure the comfort of the subjects.
Ferumoxytol administration:
The MRI imaging with ferumoxytol as a contrast agent will be conducted at the scheduled visits based on timing of FGR diagnosis. Ferumoxytol will be administered in a hospital triage setting with maternal pulse and blood pressure monitoring and fetal heart rate monitoring. The pharmacy will be notified in advance of the arrival of the participant, so that they can prepare the infusion in a timely fashion and deliver it to triage upon participant's arrival. Participants will arrive at UnityPoint-Health Meriter Hospital obstetric triage unit as prescheduled for ferumoxytol infusion. Later that same day, the participants will present to the University of Wisconsin (UW) Hospital, Wisconsin Institutes for Medical Research (WIMR) or 1 S. Park location for their pre-scheduled MRI. In the triage unit, the nurse will obtain baseline vital signs, including maternal pulse, blood pressure, and fetal heart rate. Following this, the nurse will initiate an infusion dose of ferumoxytol. Ferumoxytol will be administered intravenously, by infusion, over 30 minutes. The participants will be monitored at 5 to 15-minute intervals, for pulse, blood pressure, respiration, and fetal heart rate. The MRI scanning procedure will be conducted at the UW Hospital, WIMR or 1 S. Park location for approximately 60 minutes.
The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Investigators plan to dilute half of the recommended initial dose, i.e. 255 mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Feraheme will be given only once, in one infusion of 255 mg to each participant who has consented for this study.
- Conditions
- Fetal Growth Retardation
- Being tested
- Ferumoxytol infusion, MRI scan
- Medical subject headings
- Fetal Growth Retardation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ferumoxytol infusionDrug
Also called Feraheme
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 scanProcedure or surgery
The MRI scanning procedure will last for approximately 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ferumoxytol infusion; Procedure: MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2021
- Study start15 Apr 2021
- Primary completion6 Oct 2021
- Study completion6 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fetal Growth RetardationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Responsible party
- Sponsor
- Investigators
- Dinesh Shah, MD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04839185
- Sponsor's protocol ID
- 2019-1432
- Other IDs
- A532860, SMPH/OBSTET & GYNECOL, 1U01HD087216-01, Protocol ver: 04-06-2020
- Status last verified
- May 2023
- First submitted
- 7 Apr 2021
- Last updated
- 22 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Placental Lesions in Fetal Growth Restriction
- ClinicalTrials.gov ID
- NCT04839185
- Acronym / sponsor ID
- 2019-1432
- Conditions
- Fetal Growth Retardation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 6 Oct 2021 (actual)
- Study completion
- 6 Oct 2021 (actual)
- First posted
- 9 Apr 2021 (actual)
- Results
- Posted 12 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Research Procedure Descriptions
Blood/urine collection for research Blood and urine samples are collected at the consenting visit and at the time of delivery. A total of 10 mL, of blood is collected via venipuncture along with an aliquot of a urine sample. For research visits that coincide with clinical visits, research blood samples are collected in conjunction with clinical samples, saving subjects an additional needle stick. All subjects are asked if they wish to have left over research samples banked for future unspecified research. Blood and urine samples will be analyzed to monitor relevant maternal growth factors, multiplex assays for Cytokine panel and Matrix metalloproteinases (MMPs). Urine will be tested for Shed VE-Cadherin (VE Cad).
60 minute MRI: This MRI scan will take approximately 60 minutes. Prior to entering the MR suite, subjects are screened again for MRI safety and compatibility. The MR imaging exam is expected to take approximately 60 minutes with some additional time to get subjects comfortably placed in the scanner. Subjects are made as comfortable as possible in the bore and are provided with an alarm, which allows them to get the attention of the MR technologist conducting the scan. There is a break between scans to ensure the comfort of the subjects.
Ferumoxytol administration:
The MRI imaging with ferumoxytol as a contrast agent will be conducted at the scheduled visits based on timing of FGR diagnosis. Ferumoxytol will be administered in a hospital triage setting with maternal pulse and blood pressure monitoring and fetal heart rate monitoring. The pharmacy will be notified in advance of the arrival of the participant, so that they can prepare the infusion in a timely fashion and deliver it to triage upon participant's arrival. Participants will arrive at UnityPoint-Health Meriter Hospital obstetric triage unit as prescheduled for ferumoxytol infusion. Later that same day, the participants will present to the University of Wisconsin (UW) Hospital, Wisconsin Institutes for Medical Research (WIMR) or 1 S. Park location for their pre-scheduled MRI. In the triage unit, the nurse will obtain baseline vital signs, including maternal pulse, blood pressure, and fetal heart rate. Following this, the nurse will initiate an infusion dose of ferumoxytol. Ferumoxytol will be administered intravenously, by infusion, over 30 minutes. The participants will be monitored at 5 to 15-minute intervals, for pulse, blood pressure, respiration, and fetal heart rate. The MRI scanning procedure will be conducted at the UW Hospital, WIMR or 1 S. Park location for approximately 60 minutes.
The recommended dose of Feraheme is an initial 510 mg dose followed by a second 510 mg dose 3 to 8 days later. Investigators plan to dilute half of the recommended initial dose, i.e. 255 mg in 50 mL of 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP. Feraheme will be given only once, in one infusion of 255 mg to each participant who has consented for this study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic: Ferumoxytol MRI | Other | Drug: Ferumoxytol infusion, Procedure: MRI scanThe 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ferumoxytol infusionAlso: FerahemeFerumoxytol 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. | Drug | Diagnostic: Ferumoxytol MRI |
| MRI scanThe MRI scanning procedure will last for approximately 60 minutes. | Procedure or surgery | Diagnostic: Ferumoxytol MRI |
Primary outcome
Number of Participants for Which Intervillous Placental Blood is Detected
Time frame: 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.
Number of Participant for Which Placental Lesions Are Detected
Time frame: up to 1 week
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.
Number of Participants for Which Macrophage at the Implementation Site Are Detected
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dinesh Shah, MD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Ferumoxytol infusion and MRI scan in people with Fetal Growth Retardation, run by University of Wisconsin, Madison 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?
The sponsor lists 4 inclusion and 9 exclusion criteria. 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: finished, as of the sponsor's last update on 22 Aug 2025. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants for Which Intervillous Placental Blood is Detected (time frame: up to 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.