- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04508751
PED NEONAT 20-000599 Fetal Body Composition
Fetal Body Composition and Free-Breathing Magnetic Resonance Imaging
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
1.1 OBJECTIVE This study's goals are to: 1) use free-breathing magnetic resonance imaging (FB-MRI) to measure fetal body composition in the third trimester and 2) determine how the FB-MRI quantitative measurements compare to growth parameters at birth.
1.2 HYPOTHESES AND SPECIFIC AIMS
To accomplish the investigators' objectives, the aims and hypotheses are as follows:
Specific Aim 1:
In a prospective study in women with healthy pregnancies and women with fetuses that have intrauterine growth restriction (IUGR) and gestational diabetes, the investigators will quantify fetal subcutaneous, visceral, and brown adipose tissue volumes and proton-density fat fraction (PDFF) using FB-MRI in the third trimester.
Hypothesis 1: Using a FB-MRI technique the investigators will find the following,
- The growth-restricted fetus will have less visceral, subcutaneous, and brown adipose tissue volume and PDFF when compared to healthy fetuses and fetuses whose mothers have gestational diabetes.
- Fetuses whose mothers have gestational diabetes will have a greater subcutaneous and visceral adipose tissue volume and PDFF compared to healthy fetuses.
Specific Aim 2:
In a prospective study in pregnant women and their fetuses, the investigators will compare volume and PDFF measurements of fetal visceral, subcutaneous, and brown adipose tissue obtained with FB-MRI to birth growth parameters of these infants.
Hypothesis 2: The volume and PDFF of fetal visceral and subcutaneous adipose tissue will correlate positively with birth weight and length z-score.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
California
-
Los Angeles, California, United States, 90095
- University of California-Los Angeles
-
Santa Monica, California, United States, 90404
- University of California- Los Angeles Santa Monica
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Pregnant women with singleton pregnancies (healthy cohort)
- Pregnant women with fetuses with weights < 10th percentile weight for gestational age (IUGR cohort)
- Pregnant women with gestational diabetes (diabetes cohort)
Exclusion Criteria:
- Pregnant minors
- Major congenital anomalies or disease processes in the fetus
- Fetus with known chromosomal anomalies
- Mothers who do not plan to deliver at UCLA
- Multiple pregnancy (i.e. twins, triplets, etc)
- History of claustrophobia
- Contraindications to MRI such as metallic devices in the body that are not MRI compatible
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: Healthy Pregnancy
Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines. Maternal demographics, pregnancy clinical course and infant growth parameters will be recorded. |
Subject will have a one time MRI scan.
|
Other: Pregnant Mothers with gestational diabetes
Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines. Maternal demographics, pregnancy clinical course and infant growth parameters will be recorded. |
Subject will have a one time MRI scan.
|
Other: Pregnant Mothers with infants diagnosed with IUGR
Patient will have a fetal MRI performed in the third trimester. All MRI scans will be performed on 3 T scanners (e.g., Skyra or Prisma, Siemens). Our newly developed FB-MRI quantification technique leverages a multi-echo 3D stack-of-radial sampling trajectory with golden-angle acquisition ordering to suppress motion artifacts and enable free-breathing imaging of the abdomen in around 5 minutes. In addition, our FB-MRI technique is compatible with data under sampling to accelerate the free-breathing scan to 1-2 min. In this study, we will optimize the parameters of our FB-MRI technique (spatial resolution, spatial coverage, acceleration factor) to balance trade-offs between scan time, image quality, fat quantification accuracy, and patient comfort/compliance. Subjects will be provided ear plugs to limit amount of noise from MRI machines. Maternal demographics, pregnancy clinical course and infant growth parameters will be recorded. |
Subject will have a one time MRI scan.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Maternal Visceral Adipose Tissue Volume
Time Frame: During the procedure (MRI)
|
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps.
The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis.
Visceral adipose tissue PDFF values will be directly measured from regions of interest.
|
During the procedure (MRI)
|
Fetal Liver PDFF
Time Frame: During the procedure (MRI)
|
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images.
The distribution/extent of hepatic fat will be manually delineated/drawn on the 3D MRI images and PDFF maps.
This work will be performed by PI Strobel with validation from PI Wu.
|
During the procedure (MRI)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fetal Subcutaneous Tissue Volume
Time Frame: During the procedure (MRI)
|
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps.
The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis.
Subcutaneous adipose tissue PDFF values will be directly measured from regions of interest.
|
During the procedure (MRI)
|
Maternal Subcutaneous Tissue Volume
Time Frame: During the procedure (MRI)
|
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images.
The distribution/extent of subcutaneous fat will be manually delineated/drawn on the 3D MRI images and PDFF maps and used to calculate volume of subcutaneous adipose tissue.
This work will be performed by PI Strobel with validation from PI Wu.
|
During the procedure (MRI)
|
Maternal Hepatic Fat PDFF
Time Frame: During the procedure (MRI)
|
MRI data will be reconstructed by Siemens scanner software to produce 3D fat-water separated images and PDFF maps.
The FB-MRI radial data will be transferred to a separate workstation for custom reconstruction of 3D fat-water-separated images and PDFF maps and analysis.
Hepatic adipose tissue PDFF values will be directly measured from regions of interest.
|
During the procedure (MRI)
|
Collaborators and Investigators
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
- 20-000599
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.
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