PED NEONAT 20-000599 Fetal Body Composition

NCT04508751 | Completed Phase 1 Results

• 1 other identifier: 20-000599
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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.

Conditions

IUGR; Gestational Diabetes; Pregnancy Related

Outcome Measures

Primary Outcomes (2)

• 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)

Secondary Outcomes (3)

• Fetal Subcutaneous Tissue Volume

  During the procedure (MRI)

• Maternal Subcutaneous Tissue Volume

  During the procedure (MRI)

• Maternal Hepatic Fat PDFF

  During the procedure (MRI)

Study Arms (3)

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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging

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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging

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.

Other: 3T "Free-Breathing" Fetal Magnetic Resonance Imaging

Interventions

3T "Free-Breathing" Fetal Magnetic Resonance Imaging OTHER

Subject will have a one time MRI scan.

Healthy Pregnancy; Pregnant Mothers with gestational diabetes; Pregnant Mothers with infants diagnosed with IUGR

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Self-identified female patients who are pregnant
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (2)

University of California-Los Angeles

Los Angeles, California, 90095, United States

Location

University of California- Los Angeles Santa Monica

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Kara Calkins
• Organization: University of California Los Angeles

kcalkins@mednet.ucla.edu

3108259330

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 11, 2020
• Study Start: August 17, 2020
• Primary Completion: September 27, 2021
• Study Completion: May 18, 2022
• Last Updated: August 30, 2023
• Results First Posted: August 30, 2023

Record last verified: 2022-10

Locations

US (2)