Advanced Fetal MRI for Pregnancy Imaging

Overseen By P. Ellen Grant, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Boston Children's Hospital

Disqualifiers: Implanted metal, Claustrophobia, Medically unstable, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

300 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The trial aims to improve MRI imaging for pregnant women by using specially designed equipment and techniques, including an investigational MRI coil tailored for pregnancy. The goal is to obtain clearer, more reliable images of the fetus than current methods provide. Pregnant women between 18 and 40 weeks, whether experiencing a healthy pregnancy or having concerns about fetal health, might be suitable candidates. Participants will undergo either a 60-minute full MRI or a 15-minute add-on MRI, depending on their situation and the location of their clinical MRI. As an unphased trial, this study offers participants the chance to contribute to advancements in prenatal imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this investigational MRI coil is safe for pregnant women?

Research has shown that MRI is generally safe during pregnancy. For over 30 years, thousands of pregnant women have undergone MRI scans without proven risks to themselves or their unborn babies. Most studies have found no harmful effects of MRI on unborn babies. Although some theoretical concerns exist, no solid evidence of harm has been identified. MRI is one of the recommended imaging methods for pregnant patients. The MRI coil tested in this trial is specifically designed for pregnant women and aims to improve the quality of images of the unborn baby. Overall, evidence suggests that this procedure is well-tolerated and safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it introduces an investigational MRI coil specifically designed for pregnant women, which is not typically available in standard fetal MRI procedures. This coil, used in conjunction with advanced research MRI sequences, aims to provide clearer and more detailed images of the fetus and placenta. This could potentially improve the detection and understanding of fetal and placental abnormalities, offering more accurate diagnostics than traditional MRI scans. By enhancing image clarity and detail, this approach could lead to better-informed medical decisions during pregnancy.

What evidence suggests that this investigational MRI coil is effective for obtaining higher quality fetal MRI images?

Research has shown that the new MRI coil for pregnant women, tested in this trial, can enhance the quality of baby images. Participants may receive either a 60-minute full MRI scan or a 15-minute add-on MRI scan. This coil offers clearer and more detailed pictures, aiding doctors in assessing the health of the baby and placenta. Studies have found that these special MRI tools during pregnancy provide excellent details of soft tissues and a comprehensive view of the baby. This allows doctors to see more and identify potential issues earlier. Early findings suggest that these specially designed MRI coils can significantly improve pregnancy imaging. ^{6 7 8 9 10}

Who Is on the Research Team?

P. Ellen Grant, MD

Principal Investigator

Boston Children's Hospital

Are You a Good Fit for This Trial?

This trial is for pregnant women with either a healthy pregnancy or concerns for fetal abnormalities, between 18 and 40 weeks of gestation. They must be referred for an MRI by their obstetrician if there are concerns. Women can't join if they're claustrophobic, have metal implants, non-removable piercings, pacemakers, or are medically unstable.

Inclusion Criteria

should eat a healthy diet

I am between 18 and 40 weeks pregnant.

Gestational age between 18 and 40 weeks AND Pregnant women with a healthy pregnancy OR Pregnant women with a concern for fetal/placental abnormalities referred for a clinical fetal MRI by their obstetrician OR Pregnant women with a concern for fetal/placental abnormalities NOT referred for a clinical fetal MRI by their obstetrician

Exclusion Criteria

Pregnant women with a contraindication to MRI (implanted metal, non-removable piercings, pacemaker, etc)

Pregnant women who are medically unstable for an MRI

You are pregnant and have a fear of enclosed spaces.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

MRI Scan

Participants undergo a 60 minute research full MRI scan using investigational MRI coils and sequences

1 day

1 visit (in-person)

Add-on MRI Scan

Participants with specific concerns undergo a 15 minute research add-on MRI scan

1 day

1 visit (in-person)

Follow-up

Participants are monitored for image quality and physiological data comparison

up to 41 months

What Are the Treatments Tested in This Trial?

Interventions

• Investigational MRI coil designed for pregnant women
• MRI Scan

Trial Overview The study tests a new MRI coil designed specifically for pregnant women alongside advanced image acquisition techniques to improve the quality of fetal MRI images compared to current methods.

How Is the Trial Designed?

Group I: 60 minute research full MRI scan Experimental Treatment 2 Interventions

Pregnant women who are able to have an MRI are eligible for the 60 minute research full MRI scan. Pregnant women may have a healthy pregnancy, a concern for fetal/placental abnormalities with a clinical fetal MRI ordered by their doctor, or a concern for fetal/placental abnormalities without a clinical fetal MRI ordered by their doctor. The investigational MRI coil designed for pregnant women and research MRI sequences will be tested during the 60 minute research scan.

Group II: 15 minute research add-on MRI scan Experimental Treatment 1 Intervention

Pregnant women with a concern for fetal/placental abnormalities with a clinical fetal MRI at Boston Children's Hospital are eligible for the 15 minute research add-on MRI scan. The research MRI sequences will also be tested during the add-on research MRI scan.

Who Is Running the Clinical Trial?

Boston Children's Hospital

Lead Sponsor

Trials

801

Recruited

5,584,000+

Massachusetts Institute of Technology

Collaborator

Trials

104

Recruited

12,810,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Fast magnetic resonance imaging (MR) techniques allow for high-resolution imaging of both the mother and fetus during pregnancy without the need for sedation, enhancing safety and comfort for patients.

These advanced imaging techniques are effective in evaluating various conditions such as adnexal masses, placenta accreta, and fetal anomalies like ventriculomegaly, providing critical information for maternal and fetal health management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstetric MR imaging. Levine, D., Barnes, PD., Edelman, RR.[2007]

Fetal MRI is increasingly important in the clinical evaluation of pregnant women, primarily conducted at 1.5 T, but there is growing interest in using 3.0 T MRI for better fetal imaging.

This article serves as a reference for the application of 3.0 T MRI in prenatal diagnostics, highlighting its potential for more precise fetal depiction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal MRI at 3T-ready for routine use? Weisstanner, C., Gruber, GM., Brugger, PC., et al.[2022]

Magnetic resonance imaging (MRI) has become increasingly important in fetal medicine, particularly for diagnosing central nervous system malformations that are not easily detected by ultrasound, such as agenesis of the corpus callosum.

Recent studies indicate that MRI significantly enhances the prenatal diagnosis and management of congenital abnormalities, including improved accuracy in identifying placental abnormalities and various non-central nervous system lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal magnetic resonance imaging: a review. Laifer-Narin, S., Budorick, NE., Simpson, LL., et al.[2007]

Only 55% of pregnant women accepted participation in a study involving fetal MRI, with a significant 66% declining the examination due to perceived burdens and concerns related to the MRI process.

Fetal MRI was successfully performed in 98% of clinical cases, indicating high acceptance in situations where there were suspected anomalies, while the use of sedatives was common in both research and clinical settings, suggesting a need for better communication about the procedure's safety and benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal MRI, lower acceptance by women in research vs. clinical setting. van der Knoop, BJ., Vermeulen, RJ., Verbeke, JIML., et al.[2019]

Modern MRI techniques are being applied to study fetal brain development non-invasively, offering advantages over traditional ultrasound methods, particularly in providing detailed structural and functional insights.

Most studies focus on normal fetuses in the third trimester, with fewer investigations into pathological conditions, highlighting the potential for MRI to enhance understanding of both typical and atypical fetal brain development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantitative magnetic resonance imaging of the fetal brain in utero: Methods and applications. Biegon, A., Hoffmann, C.[2021]

In a study of 43 symptomatic pregnant women, MRI proved to be a valuable tool for diagnosing various conditions, including brain abnormalities and abdominal issues, with significant findings such as multiple sclerosis and colon cancer.

MRI is considered the best imaging method for pregnant women, especially for cases where ultrasound is inconclusive, allowing for non-invasive evaluation of complex structures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic Imaging of Pregnant Women - The Role of Magnetic Resonance Imaging. Bekiesińska-Figatowska, M., Romaniuk-Doroszewska, A., Szkudlińska-Pawlak, S., et al.[2020]

Exposure to MRI during the first trimester of pregnancy does not appear to increase the risk of harm to the fetus or lead to adverse outcomes in early childhood, based on a study of over 1.4 million births.

However, gadolinium-enhanced MRI during pregnancy is associated with a higher risk of certain rheumatological and skin conditions, as well as an increased risk of stillbirth or neonatal death, indicating caution is needed when using gadolinium in pregnant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association Between MRI Exposure During Pregnancy and Fetal and Childhood Outcomes. Ray, JG., Vermeulen, MJ., Bharatha, A., et al.[2022]

In a study comparing fetal MRI at 3 tesla (T) and 1.5 T, 3 T did not show a significant improvement in overall image quality, with less than half of the radiologists preferring it over 1.5 T.

Fetal MRIs at 3 T resulted in longer exam times (75 minutes) and increased artifacts compared to 1.5 T (55.5 minutes), suggesting that 1.5 T is the more practical choice for routine clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utilization of 3-T fetal magnetic resonance imaging in clinical practice: a single-institution experience. Nagaraj, UD., Calvo-Garcia, MA., Merrow, AC., et al.[2021]

Fetal MRI has been utilized for over 30 years and is increasingly recognized for its role in clinical care, with over 3000 published articles supporting its use.

Advancements in MRI technology, including the potential use of 3.0-T systems, are paving the way for improved imaging of both healthy and at-risk fetuses, enhancing our understanding of fetal development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal magnetic resonance imaging at 3.0 T. Welsh, RC., Nemec, U., Thomason, ME.[2022]

Magnetic resonance imaging (MRI) is increasingly used during pregnancy for diagnosing various conditions, but there are safety concerns that may cause anxiety for patients and healthcare providers.

Key safety issues include energy deposition, acoustic noise, and the use of gadolinium-based contrast agents, which should be avoided when possible, based on data from both animal and human studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Magnetic Resonance Imaging in Pregnancy. Maralani, PJ., Pai, V., Ertl-Wagner, BB.[2023]

Fast MRI techniques allow for rapid imaging of the fetus in just 300-400 milliseconds, making it possible to perform scans without the need for sedation.

Fetal MRI is particularly valuable for assessing central nervous system anomalies, clarifying complex fetal conditions that ultrasound may not fully reveal, and aiding in the planning of fetal surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fetal magnetic resonance imaging. Levine, D.[2007]

MRI is a safe and effective imaging tool for pregnant patients due to its excellent soft tissue contrast and use of nonionizing radiation, making it preferable over other imaging methods.

However, the use of intravenous contrast agents, such as gadolinium-based compounds, requires careful consideration of potential risks to both the fetus and nursing infants, highlighting the need for thorough risk assessment before MRI procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic Resonance Safety: Pregnancy and Lactation. Little, JT., Bookwalter, CA.[2021]

Citations

1. withpower.com withpower.com/trial/phase-6-2016-36328

Advanced Fetal MRI for Pregnancy Imaging This suggests that the investigational MRI coil could improve imaging quality and diagnostic capabilities during pregnancy. Show more.

2. childrenshospital.org childrenshospital.org/clinical-trials/nct02840019

Advanced Fetal Imaging - Phase II The goal of Advanced Fetal Imaging - Phase II is to advance fetal MRI imaging by designing MRI coils specifically for pregnant women.

3. mdpi.com mdpi.com/2075-4418/15/2/208

Fetal Safety in MRI During Pregnancy: A Comprehensive ... This review examines the current evidence on the safety of MRI during pregnancy, with a focus on 3 T MRI and contrast agents.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6312740/

A Dedicated 36-channel Receive Array for Fetal MRI at 3 T As the proposed coil array provides good image quality and large body coverage, it can facilitate fetal MRI in various clinical applications.

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0146000513000700

Benefits and risks of MRI in pregnancy MRI can image the fetus in any plane, providing a large field of view of the fetus and placenta with excellent soft tissue resolution.

6. radiology.ucsf.edu radiology.ucsf.edu/patient-care/patient-safety/ct-mri-pregnancy

CT and MR Pregnancy Guidelines | UCSF Radiology In general, it should be noted that most studies evaluating MRI safety during pregnancy show no ill effects [1-4].

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11765095

Fetal Safety in MRI During Pregnancy - PubMed Central - NIH Although MRI is widely regarded as safe for fetal imaging, several theoretical concerns regarding the use of MRI during pregnancy may contribute ...

8. radiologyinfo.org radiologyinfo.org/en/info/safety-mri-pregnancy

MRI Safety During Pregnancy There are no proven risks to pregnant women or unborn babies from MRI exams. Over the last 30 years, thousands of pregnant women have had MRI exams.

9. link.springer.com link.springer.com/article/10.1007/s00117-023-01207-7

Safety of Magnetic Resonance Imaging in Pregnancy In this review, we critically discuss the main safety concerns of Magnetic Resonance Imaging (MRI) in pregnancy including energy deposition, acoustic noise, ...

10. acog.org acog.org/clinical/clinical-guidance/committee-opinion/articles/2017/10/guidelines-for-diagnostic-imaging-during-pregnancy-and-lactation

Guidelines for Diagnostic Imaging During Pregnancy and ... Ultrasonography and magnetic resonance imaging are not associated with risk and are the imaging techniques of choice for the pregnant patient.