- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04839185
Placental Lesions in Fetal Growth Restrictions
Detection of Placental Lesions in Fetal Growth Restriction
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Early Phase 1
Contacts and Locations
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53715
- University of Wisconsin-Madison
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: 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 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.
Other Names:
The MRI scanning procedure will last for approximately 60 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
up to 1 week
|
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.
|
up to 1 week
|
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.
|
up to 1 week
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Dinesh Shah, MD, University of Wisconsin, Madison
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-1432
- A532860 (Other Identifier: UW Madison)
- SMPH/OBSTET & GYNECOL (Other Identifier: UW Madison)
- 1U01HD087216-01 (U.S. NIH Grant/Contract)
- Protocol ver: 04-06-2020 (Other Identifier: HS-IRB, UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Fetal Growth Retardation
-
amera mohamedUnknownThe Relationship Between Second Trimester Placental Growth Factor Level and Fetal Growth RestrictionIntra Uterine Growth RetardationEgypt
-
Johns Hopkins UniversityWithdrawnFetal Growth Retardation | Intrauterine Growth Restriction | Intrauterine Growth Retardation | Fetal Growth Restriction
-
Poitiers University HospitalCompletedIntrauterine Growth Retardation (IUGR)France
-
PfizerCompletedGrowth Disorders | Intrauterine Growth RetardationFrance
-
Nantes University HospitalTerminatedIntra Uterine Growth RetardationFrance
-
Van Bölge Eğitim ve Araştırma HastanesiCompletedIntrauterine RetardationTurkey
-
Ain Shams Maternity HospitalCompletedFasting | Fetal Growth Retardation, Antenatal (Disorder)
-
Merck KGaA, Darmstadt, GermanyMerck Serono S.A., GenevaCompletedChildren Born With Serious Intra-uterine Growth Retardation
-
University Hospital, GrenobleRegistre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère,... and other collaboratorsUnknownStillbirth | Infant, Small for Gestational Age | Intrauterine Growth RetardationFrance
-
University of South FloridaCompleted
Clinical Trials on Ferumoxytol infusion
-
Auerbach Hematology Oncology Associates P CAMAG Pharmaceuticals, Inc.CompletedIron Deficiency AnemiaUnited States
-
Michael IvNational Cancer Institute (NCI)WithdrawnChildhood Brain NeoplasmUnited States
-
University of UtahCompletedMultiple Sclerosis | Multiple Sclerosis, Secondary Progressive | Secondary Progressive Multiple SclerosisUnited States
-
Allegheny Singer Research Institute (also known...Active, not recruitingLiver Neoplasms | Hepatocellular Carcinoma | Liver Metastases | Liver Cancer | Liver Carcinoma | Hepatocellular Cancer | Hepatic Cirrhosis | Hepatic Carcinoma | Hepatic AtrophyUnited States
-
Massachusetts General HospitalCompletedPapillary Carcinoma of Thyroid Gland | Metastatic Medullary Thyroid Cancer | Follicular Thyroid Cancer Lymph Node MetastasisUnited States
-
OHSU Knight Cancer InstituteOregon Health and Science University; Radiological Society of North AmericaTerminatedStage III Rectal Cancer AJCC v7 | Stage IIIA Rectal Cancer AJCC v7 | Stage IIIB Rectal Cancer AJCC v7 | Stage IIIC Rectal Cancer AJCC v7 | Locally Advanced Rectal CarcinomaUnited States
-
OHSU Knight Cancer InstituteNational Cancer Institute (NCI); Oregon Health and Science University; National... and other collaboratorsRecruitingPancreatic Adenocarcinoma | Familial Pancreatic Cancer | Pancreatic Intraductal Papillary-Mucinous NeoplasmUnited States
-
Michael IvCompletedBrain Injury | Brain Cancer | Brain Tumors | Primary Brain Neoplasm | Ischemic Cerebrovascular Accident | Central Nervous System Degenerative Disorder | Central Nervous System Infectious Disorder | Central Nervous System Vascular Malformation | Hemorrhagic Cerebrovascular AccidentUnited States
-
Dana-Farber Cancer InstituteWithdrawn
-
AMAG Pharmaceuticals, Inc.UnknownPeripheral Arterial Disease (PAD)United States