Magnetic Resonance Imaging (MRI) of Ventriculomegaly: Morphology and Outcome

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Children's Hospital Boston
Information provided by (Responsible Party):
Deborah Levine, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
ClinicalTrials.gov Identifier:
NCT00870675
First received: March 26, 2009
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

This study compares the accuracy of fast magnetic resonance imaging (MRI) using the half Fourier single shot rapid acceleration with relaxation enhancement technique to ultrasound in the diagnosis of fetal abnormalities. The investigators' specific aim is to perform MRI examinations with ultrafast MRI on fetuses with sonographic morphologic abnormalities. The investigators' hypotheses are that 1) MRI will demonstrate fetal morphologic abnormalities; and 2) MRI will add additional information to the sonographic diagnosis which may directly affect maternal and/or neonatal care.


Condition
Ventriculomegaly

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: MRI of Ventriculomegaly: Morphology and Outcome

Resource links provided by NLM:


Further study details as provided by National Institute for Biomedical Imaging and Bioengineering (NIBIB):

Primary Outcome Measures:
  • Live birth [ Time Frame: within 6 months of enrollment ] [ Designated as safety issue: No ]
  • Postnatal imaging abnormalities [ Time Frame: Within 3 years of birth ] [ Designated as safety issue: No ]
  • Postnatal developmental delay [ Time Frame: Within 3 years of birth ] [ Designated as safety issue: No ]

Enrollment: 434
Study Start Date: January 1996
Study Completion Date: June 2011
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
ventriculomegaly
Pregnant women carrying a fetus with the ultrasound finding of enlarged ventricles (ventriculomegaly).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Pregnant women carrying a fetus diagnosed by ultrasound as having ventriculomegaly.

Criteria

Inclusion Criteria:

  • Sonographic finding of ventriculomegaly
  • Ability and willingness of the patient to provide informed consent and cooperate for the examination
  • Absence of contraindications for MRI (claustrophobia, pacemaker, intracranial clips, intra-articular ocular debris)
  • All patients must be greater than 18 years old and must be in the second or third trimester of pregnancy

Exclusion Criteria:

  • Contraindications to MRI
  • Age less than 18
  • First trimester of pregnancy
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00870675

Locations
United States, Massachusetts
Childrens Hospital Boston
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Beth Israel Deaconess Medical Center
Children's Hospital Boston
Investigators
Principal Investigator: Deborah Levine, MD Beth Israel Deaconess Medical Center
  More Information

Publications:

Responsible Party: Deborah Levine, Professor of Radiology, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
ClinicalTrials.gov Identifier: NCT00870675     History of Changes
Other Study ID Numbers: 2001-P-00842/6, NIH NIBIB 01998
Study First Received: March 26, 2009
Last Updated: September 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institute for Biomedical Imaging and Bioengineering (NIBIB):
Ventriculomegaly
ultrasound
MRI
fetus

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on October 22, 2014