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Obesity is an ongoing public health problem that is difficult to treat. There is evidence that obesity has fetal origins. Body composition, including visceral, subcutaneous, brown, and hepatic fat have been found to be important predictors in obesity and metabolic syndrome. Magnetic resonance imaging (MRI) can quantify body composition that does not require radiation but is motion limited. The investigators have developed a motion-compensated MRI sequence, also known as "free breathing" MRI. In this study, the investigators plan to obtain free-breathing MRIs of pregnant women in the third trimester of pregnancy. MRIs will be obtained from healthy mothers, mothers with growth-restricted fetuses, and mothers with gestational diabetes. The different types of adipose tissue will be measured and compared between groups and correlated to birth growth parameters. The goal is this study is to assess if motion-compensated MRI can help predict early growth patterns in infancy.
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,
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Pregnancy | Other | 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. |
|
| Pregnant Mothers with gestational diabetes | Other | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3T "Free-Breathing" Fetal Magnetic Resonance Imaging | Other | Subject will have a one time MRI scan. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Visceral Adipose Tissue Volume | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Subcutaneous Tissue Volume | 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) |
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Inclusion Criteria:
Exclusion Criteria:
Self-identified female patients who are pregnant
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California-Los Angeles | Los Angeles | California | 90095 | United States | ||
| University of California- Los Angeles Santa Monica |
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One subject was excluded due to inability to schedule MRI scan
Recruited by study investigator or obstetrician through medical clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. 3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan. |
| FG001 | 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. 3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan. |
| FG002 | 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. 3T "Free-Breathing" Fetal Magnetic Resonance Imaging: Subject will have a one time MRI scan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Pregnancy | Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM. |
| BG001 | Pregnant Mothers With Gestational Diabetes | GDM was defined as a positive glucola screen at 26 to 32 weeks gestation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Maternal Visceral Adipose Tissue Volume | 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. | Posted | Median | Inter-Quartile Range | mm3 | During the procedure (MRI) |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Pregnancy | Pregnancy without fetal anatomic or chromosomal abnormalities, FGR, or GDM. |
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Because this is a pilot study, our sample size is limited, and the results should be considered exploratory. We did not longitudinally measure body composition during pregnancy and infancy. Future follow-up would be required to understand if maternal and fetal body composition are truly associated with future childhood and adulthood obesity and various metabolic complications.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Kara Calkins | University of California Los Angeles | 3108259330 | kcalkins@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 20, 2020 | Aug 3, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D016640 | Diabetes, Gestational |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D003920 | Diabetes Mellitus |
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Pregnant mothers who's infants were diagnosed with intrauterine growth restriction and mothers with pregnancies complicated by gestational diabetes, and mothers with healthy uncomplicated pregnancies will be recruited to have a fetal MRI in the third trimester.
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| Pregnant Mothers with infants diagnosed with IUGR |
| Other |
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. |
|
| Maternal Subcutaneous Tissue Volume | 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 | 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) |
| Santa Monica |
| California |
| 90404 |
| United States |
| BG002 | Pregnant Mothers With Infants Diagnosed With IUGR | IUGR was defined as fetal weight and abdominal circumference <10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Glucose tolerance test at 1 hour | Median | Inter-Quartile Range | mg/dL |
|
| OG002 | Pregnant Mothers With Infants Diagnosed With IUGR | IUGR was defined as fetal weight and abdominal circumference <10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes |
|
|
| Primary | Fetal Liver PDFF | 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. | Posted | Median | Inter-Quartile Range | percentage of triglycerides/ | During the procedure (MRI) |
|
|
|
| Secondary | Fetal Subcutaneous Tissue Volume | 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. | Posted | Median | Inter-Quartile Range | mm3 | During the procedure (MRI) |
|
|
|
| Secondary | Maternal Subcutaneous Tissue Volume | 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. | Posted | Median | Inter-Quartile Range | mm3 | During the procedure (MRI) |
|
|
|
| Secondary | Maternal Hepatic Fat PDFF | 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. | Posted | Median | Inter-Quartile Range | % triglycerides | During the procedure (MRI) |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Pregnant Mothers With Gestational Diabetes | GDM was defined as a positive glucola screen at 26 to 32 weeks gestation. | 0 | 5 | 0 | 5 | 0 | 5 |
| EG002 | Pregnant Mothers With Infants Diagnosed With IUGR | IUGR was defined as fetal weight and abdominal circumference <10th percentile on ultrasound for a given gestational age or per obstetrician documentation on at least two medical notes | 0 | 5 | 0 | 5 | 0 | 5 |
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| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |