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PED NEONAT 20-000599 Fetal Body Composition

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ClinicalTrials.gov Identifier: NCT04508751
Recruitment Status : Recruiting
First Posted : August 11, 2020
Last Update Posted : September 29, 2021
Sponsor:
Information provided by (Responsible Party):
Katie Strobel, MD, University of California, Los Angeles

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
IUGR Gestational Diabetes Pregnancy Related Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging Phase 1

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,

  1. 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.
  2. 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 15 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Fetal Body Composition and Free-Breathing Magnetic Resonance Imaging
Actual Study Start Date : August 17, 2020
Actual Primary Completion Date : September 27, 2021
Estimated Study Completion Date : June 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Subject will have a one time MRI scan.

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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Subject will have a one time MRI scan.

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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging
Subject will have a one time MRI scan.




Primary Outcome Measures :
  1. Visceral adipose tissue 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. Visceral adipose tissue PDFF values will be directly measured from regions of interest.

  2. 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. 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 visceral adipose tissue. This work will be performed by PI Strobel with validation from PI Wu.


Secondary Outcome Measures :
  1. Subcutaneous tissue 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. Subcutaneous adipose tissue PDFF values will be directly measured from regions of interest.

  2. 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.

  3. Brown tissue 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. Brown adipose tissue PDFF values will be directly measured from regions of interest.

  4. Brown 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 brown adipose tissue. This work will be performed by PI Strobel with validation from PI Wu.

  5. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Self-identified female patients who are pregnant
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04508751


Contacts
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Contact: Katie Strobel, MD 3109236784 kmstrobel@mednet.ucla.edu
Contact: Kara Calkins, MD kcalkins@mednet.ucla.edu

Locations
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United States, California
University of California-Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Kara Calkins, MD         
Principal Investigator: Kara Calkins, MD         
Principal Investigator: Katie Strobel, MD         
University of California- Los Angeles Santa Monica Recruiting
Santa Monica, California, United States, 90404
Contact: Katie Strobel, MD         
Principal Investigator: Kara Calkins, MD         
Principal Investigator: Katie Strobel, MD         
Sponsors and Collaborators
University of California, Los Angeles
  Study Documents (Full-Text)

Documents provided by Katie Strobel, MD, University of California, Los Angeles:
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Responsible Party: Katie Strobel, MD, Principle Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT04508751    
Other Study ID Numbers: 20-000599
First Posted: August 11, 2020    Key Record Dates
Last Update Posted: September 29, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases