VentriculomegalyNCT00870675
Magnetic Resonance Imaging (MRI) of Ventriculomegaly: Morphology and Outcome
An observational study of Ventriculomegaly, run by National Institute for Biomedical Imaging and Bioengineering (NIBIB) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ventriculomegaly
- How many people
- 434 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 1996to Jun 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women carrying a fetus diagnosed by ultrasound as having ventriculomegaly.
Who may be able to join
- 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
Who cannot join
- Contraindications to MRI
- Age less than 18
- First trimester of pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Childrens Hospital Boston
Boston, Massachusetts, 02115
About this study
Official title: MRI of Ventriculomegaly: Morphology and Outcome
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.
Read the detailed description
- Study Design: This is a descriptive study looking at the potential for MRI to aid in the diagnosis of fetal ventriculomegaly. It will also compare the specificity of MRI and ultrasound in diagnosing additional morphologic abnormalities.
450 pregnant women in the second and third trimester with ventriculomegaly will be asked to participate. Sonograms will be performed according the American Institute of Ultrasound in Medicine/American College of Radiology guidelines. In addition, views will be obtained of the fetal face, lips, outflow tracts, hands, and feet.
The gestational age of the fetus, interpretation of the sonogram, with sonographic abnormality and specific diagnosis will be prospectively recorded. Other data collected will be age and ethnicity of the patient, results of chromosomal analysis during the current pregnancy, and gestational age at the time of original diagnosis of abnormality during this pregnancy.
After screening for contraindications to MRI examination patients will undergo a 20 minute MRI examination. MRI examinations will be performed with a 1.5 T superconductive system (SIEMENS VISION, Erlangen, Germany or General Electric Twin, Milwaukee) using a 4-8 element body phased-array coil and/or body coil. The minimum rise time will be 600 microseconds (for a 25 milliTesla preset gradient amplitude). The whole body specific absorption rate will be kept under 1.5 watt/kilogram. Patients will be positioned supine with their feet entering the magnet bore first to minimize feelings of claustrophobia. A scout view will be obtained, and fetal images will be obtained with half Fourier single shot fast spin echo imaging imaging in the fetal sagittal, coronal, and axial planes (echo spacing of 4.2 msec, echo time=60 msec, echo train length=72, 1 acquisition, 3-5 mm section thickness, 26 x 35 cm field of view, 128 x 256 acquisition matrix). The refocusing flip angle will be minimized to decrease the amount of radiofrequency power deposition. Fetal anomalies seen with MRI will be recorded prospectively with knowledge of the sonographic findings.
Interpretation of the sonograms will be performed independently of the MR results. Interpretation of MRI examinations will be performed by reviewers with knowledge of the results of the ultrasound. The principal investigator will then combine the results from the two modalities. When the diagnosis differs between the modalities, the images will be reviewed by three radiologists and a consensus will be reached. The results of the sonogram and MRI will be communicated to the referring physician. Affect of any change in patient care will be assessed.
Comparison of MR diagnoses will be made to sonographic diagnoses. Clinical and pathologic follow-up will be obtained postnatally on all fetuses enrolled in the study.
After the baby is born, at 3 months of age, the patients will be contacted by phone by one of the investigators at Beth Israel Deaconess Medical Center to see if they want to enroll their baby in the neonatal follow-up portion of the study. This involves cognitive and motor testing of the child at Boston's Children's Hospital at age 6 months, 1 year, 2 years and 3 years of age. If a head MR or head ultrasound has not been obtained for clinical indications, it will be offered to the patient at that time.
Timeline of postnatal follow-up Number of patient for postnatal follow-up at specified age* Patients Enrolled Peripartum follow-up 6 months 18 months 24 months 36 month Any age Year 1 90 68 18 18 Year 2 90 90 54 51 105 Year 3 90 90 54 51 49 154 Year 4 90 90 54 51 49 46 200 Year 5 90 90 54 51 49 46 200 Total 450 428 234 205 146 93 678
- Data Analysis: This is primarily a descriptive study, comparing ultrasound and MR findings. Sonographic, MR, and postnatal diagnoses will be compared. Since this is a highly selected population, we cannot calculate sensitivity and specificity of each modality, but we can describe the type of findings visualized on one prenatal imaging modality that were not visualized on the other.
Data will be stored in an access database created specifically for this project
- Conditions
- Ventriculomegaly
- Keywords
- Ventriculomegaly, ultrasound, MRI, fetus
- Medical subject headings
- Hydrocephalus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ventriculomegaly | Pregnant women carrying a fetus with the ultrasound finding of enlarged ventricles (ventriculomegaly). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live birth
Measured: within 6 months of enrollment
Postnatal imaging abnormalities
Measured: Within 3 years of birth
Postnatal developmental delay
Measured: Within 3 years of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2009 (estimated)
- Study startJan 1996
- Primary completionMay 2009
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for VentriculomegalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 434 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Principal investigator, Deborah Levine, National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Investigators
- Deborah Levine, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00870675
- Sponsor's protocol ID
- 2001-P-00842/6
- Other IDs
- NIH NIBIB 01998
- Status last verified
- Sep 2014
- First submitted
- 26 Mar 2009
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Limperopoulos C, Robertson RL Jr, Khwaja OS, Robson CD, Estroff JA, Barnewolt C, Levine D, Morash D, Nemes L, Zaccagnini L, du Plessis AJ. How accurately does current fetal imaging identify posterior fossa anomalies? AJR Am J Roentgenol. 2008 Jun;190(6):1637-43. doi: 10.2214/AJR.07.3036.
PubMed 18492918Levine D, Feldman HA, Tannus JF, Estroff JA, Magnino M, Robson CD, Poussaint TY, Barnewolt CE, Mehta TS, Robertson RL. Frequency and cause of disagreements in diagnoses for fetuses referred for ventriculomegaly. Radiology. 2008 May;247(2):516-27. doi: 10.1148/radiol.2472071067.
PubMed 18430880Kazan-Tannus JF, Dialani V, Kataoka ML, Chiang G, Feldman HA, Brown JS, Levine D. MR volumetry of brain and CSF in fetuses referred for ventriculomegaly. AJR Am J Roentgenol. 2007 Jul;189(1):145-51. doi: 10.2214/AJR.07.2073.
PubMed 17579164Li Y, Estroff JA, Khwaja O, Mehta TS, Poussaint TY, Robson CD, Feldman HA, Ware J, Levine D. Callosal dysgenesis in fetuses with ventriculomegaly: levels of agreement between imaging modalities and postnatal outcome. Ultrasound Obstet Gynecol. 2012 Nov;40(5):522-9. doi: 10.1002/uog.11098.
PubMed 22262510Li Y, Estroff JA, Mehta TS, Robertson RL, Robson CD, Poussaint TY, Feldman HA, Ware J, Levine D. Ultrasound and MRI of fetuses with ventriculomegaly: can cortical development be used to predict postnatal outcome? AJR Am J Roentgenol. 2011 Jun;196(6):1457-67. doi: 10.2214/AJR.10.5422.
PubMed 21606314Pier DB, Levine D, Kataoka ML, Estroff JA, Werdich XQ, Ware J, Beeghly M, Poussaint TY, Duplessis A, Li Y, Feldman HA. Magnetic resonance volumetric assessments of brains in fetuses with ventriculomegaly correlated to outcomes. J Ultrasound Med. 2011 May;30(5):595-603. doi: 10.7863/jum.2011.30.5.595.
PubMed 21527607Li Y, Sansgiri RK, Estroff JA, Mehta TS, Poussaint TY, Robertson RL, Robson CD, Feldman HA, Barnewolt C, Levine D. Outcome of fetuses with cerebral ventriculomegaly and septum pellucidum leaflet abnormalities. AJR Am J Roentgenol. 2011 Jan;196(1):W83-92. doi: 10.2214/AJR.10.4434.
PubMed 21178039Senapati GM, Levine D, Smith C, Estroff JA, Barnewolt CE, Robertson RL, Poussaint TY, Mehta TS, Werdich XQ, Pier D, Feldman HA, Robson CD. Frequency and cause of disagreements in imaging diagnosis in children with ventriculomegaly diagnosed prenatally. Ultrasound Obstet Gynecol. 2010 Nov;36(5):582-95. doi: 10.1002/uog.7680.
PubMed 20499405Beeghly M, Ware J, Soul J, du Plessis A, Khwaja O, Senapati GM, Robson CD, Robertson RL, Poussaint TY, Barnewolt CE, Feldman HA, Estroff JA, Levine D. Neurodevelopmental outcome of fetuses referred for ventriculomegaly. Ultrasound Obstet Gynecol. 2010 Apr;35(4):405-16. doi: 10.1002/uog.7554.
PubMed 20069560
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI of Ventriculomegaly: Morphology and Outcome
- ClinicalTrials.gov ID
- NCT00870675
- Acronym / sponsor ID
- 2001-P-00842/6
- Conditions
- Ventriculomegaly
- Keywords
- Ventriculomegaly, ultrasound, MRI, fetus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 434 participants (actual)
- Lead sponsor
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)US National Institutes of Health
- Collaborators
- Beth Israel Deaconess Medical Center, Boston Children's Hospital
- Study start
- Jan 1996
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 27 Mar 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
- Study Design: This is a descriptive study looking at the potential for MRI to aid in the diagnosis of fetal ventriculomegaly. It will also compare the specificity of MRI and ultrasound in diagnosing additional morphologic abnormalities.
450 pregnant women in the second and third trimester with ventriculomegaly will be asked to participate. Sonograms will be performed according the American Institute of Ultrasound in Medicine/American College of Radiology guidelines. In addition, views will be obtained of the fetal face, lips, outflow tracts, hands, and feet.
The gestational age of the fetus, interpretation of the sonogram, with sonographic abnormality and specific diagnosis will be prospectively recorded. Other data collected will be age and ethnicity of the patient, results of chromosomal analysis during the current pregnancy, and gestational age at the time of original diagnosis of abnormality during this pregnancy.
After screening for contraindications to MRI examination patients will undergo a 20 minute MRI examination. MRI examinations will be performed with a 1.5 T superconductive system (SIEMENS VISION, Erlangen, Germany or General Electric Twin, Milwaukee) using a 4-8 element body phased-array coil and/or body coil. The minimum rise time will be 600 microseconds (for a 25 milliTesla preset gradient amplitude). The whole body specific absorption rate will be kept under 1.5 watt/kilogram. Patients will be positioned supine with their feet entering the magnet bore first to minimize feelings of claustrophobia. A scout view will be obtained, and fetal images will be obtained with half Fourier single shot fast spin echo imaging imaging in the fetal sagittal, coronal, and axial planes (echo spacing of 4.2 msec, echo time=60 msec, echo train length=72, 1 acquisition, 3-5 mm section thickness, 26 x 35 cm field of view, 128 x 256 acquisition matrix). The refocusing flip angle will be minimized to decrease the amount of radiofrequency power deposition. Fetal anomalies seen with MRI will be recorded prospectively with knowledge of the sonographic findings.
Interpretation of the sonograms will be performed independently of the MR results. Interpretation of MRI examinations will be performed by reviewers with knowledge of the results of the ultrasound. The principal investigator will then combine the results from the two modalities. When the diagnosis differs between the modalities, the images will be reviewed by three radiologists and a consensus will be reached. The results of the sonogram and MRI will be communicated to the referring physician. Affect of any change in patient care will be assessed.
Comparison of MR diagnoses will be made to sonographic diagnoses. Clinical and pathologic follow-up will be obtained postnatally on all fetuses enrolled in the study.
After the baby is born, at 3 months of age, the patients will be contacted by phone by one of the investigators at Beth Israel Deaconess Medical Center to see if they want to enroll their baby in the neonatal follow-up portion of the study. This involves cognitive and motor testing of the child at Boston's Children's Hospital at age 6 months, 1 year, 2 years and 3 years of age. If a head MR or head ultrasound has not been obtained for clinical indications, it will be offered to the patient at that time.
Timeline of postnatal follow-up Number of patient for postnatal follow-up at specified age* Patients Enrolled Peripartum follow-up 6 months 18 months 24 months 36 month Any age Year 1 90 68 18 18 Year 2 90 90 54 51 105 Year 3 90 90 54 51 49 154 Year 4 90 90 54 51 49 46 200 Year 5 90 90 54 51 49 46 200 Total 450 428 234 205 146 93 678
- Data Analysis: This is primarily a descriptive study, comparing ultrasound and MR findings. Sonographic, MR, and postnatal diagnoses will be compared. Since this is a highly selected population, we cannot calculate sensitivity and specificity of each modality, but we can describe the type of findings visualized on one prenatal imaging modality that were not visualized on the other.
Data will be stored in an access database created specifically for this project
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ventriculomegaly | – | –Pregnant women carrying a fetus with the ultrasound finding of enlarged ventricles (ventriculomegaly). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women carrying a fetus diagnosed by ultrasound as having ventriculomegaly.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Contraindications to MRI
- Age less than 18
- First trimester of pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Live birth
Time frame: within 6 months of enrollment
Postnatal imaging abnormalities
Time frame: Within 3 years of birth
Postnatal developmental delay
Time frame: Within 3 years of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2014.
- Results publication: PubMed 18492918Limperopoulos C, Robertson RL Jr, Khwaja OS, Robson CD, Estroff JA, Barnewolt C, Levine D, Morash D, Nemes L, Zaccagnini L, du Plessis AJ. How accurately does current fetal imaging identify posterior fossa anomalies? AJR Am J Roentgenol. 2008 Jun;190(6):1637-43. doi: 10.2214/AJR.07.3036.
- Results publication: PubMed 18430880Levine D, Feldman HA, Tannus JF, Estroff JA, Magnino M, Robson CD, Poussaint TY, Barnewolt CE, Mehta TS, Robertson RL. Frequency and cause of disagreements in diagnoses for fetuses referred for ventriculomegaly. Radiology. 2008 May;247(2):516-27. doi: 10.1148/radiol.2472071067.
- Results publication: PubMed 17579164Kazan-Tannus JF, Dialani V, Kataoka ML, Chiang G, Feldman HA, Brown JS, Levine D. MR volumetry of brain and CSF in fetuses referred for ventriculomegaly. AJR Am J Roentgenol. 2007 Jul;189(1):145-51. doi: 10.2214/AJR.07.2073.
- Results publication: PubMed 22262510Li Y, Estroff JA, Khwaja O, Mehta TS, Poussaint TY, Robson CD, Feldman HA, Ware J, Levine D. Callosal dysgenesis in fetuses with ventriculomegaly: levels of agreement between imaging modalities and postnatal outcome. Ultrasound Obstet Gynecol. 2012 Nov;40(5):522-9. doi: 10.1002/uog.11098.
- Results publication: PubMed 21606314Li Y, Estroff JA, Mehta TS, Robertson RL, Robson CD, Poussaint TY, Feldman HA, Ware J, Levine D. Ultrasound and MRI of fetuses with ventriculomegaly: can cortical development be used to predict postnatal outcome? AJR Am J Roentgenol. 2011 Jun;196(6):1457-67. doi: 10.2214/AJR.10.5422.
- Results publication: PubMed 21527607Pier DB, Levine D, Kataoka ML, Estroff JA, Werdich XQ, Ware J, Beeghly M, Poussaint TY, Duplessis A, Li Y, Feldman HA. Magnetic resonance volumetric assessments of brains in fetuses with ventriculomegaly correlated to outcomes. J Ultrasound Med. 2011 May;30(5):595-603. doi: 10.7863/jum.2011.30.5.595.
- Results publication: PubMed 21178039Li Y, Sansgiri RK, Estroff JA, Mehta TS, Poussaint TY, Robertson RL, Robson CD, Feldman HA, Barnewolt C, Levine D. Outcome of fetuses with cerebral ventriculomegaly and septum pellucidum leaflet abnormalities. AJR Am J Roentgenol. 2011 Jan;196(1):W83-92. doi: 10.2214/AJR.10.4434.
- Results publication: PubMed 20499405Senapati GM, Levine D, Smith C, Estroff JA, Barnewolt CE, Robertson RL, Poussaint TY, Mehta TS, Werdich XQ, Pier D, Feldman HA, Robson CD. Frequency and cause of disagreements in imaging diagnosis in children with ventriculomegaly diagnosed prenatally. Ultrasound Obstet Gynecol. 2010 Nov;36(5):582-95. doi: 10.1002/uog.7680.
- Results publication: PubMed 20069560Beeghly M, Ware J, Soul J, du Plessis A, Khwaja O, Senapati GM, Robson CD, Robertson RL, Poussaint TY, Barnewolt CE, Feldman HA, Estroff JA, Levine D. Neurodevelopmental outcome of fetuses referred for ventriculomegaly. Ultrasound Obstet Gynecol. 2010 Apr;35(4):405-16. doi: 10.1002/uog.7554.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah Levine, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventriculomegaly, run by National Institute for Biomedical Imaging and Bioengineering (NIBIB) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Live birth (time frame: within 6 months of enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00870675, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2014.