Fetal MRI Acquisition and Sequence Development

NCT05253742 | Not Yet Recruiting

• 1 other identifier: 2021P001433
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief Summary

Testing of new magnetic resonance imaging (MRI) pulse sequences (image acquisition software) for imaging the fetus to improve workflow and image quality in fetal imaging and diagnosis. The investigators would like to develop novel MRI approaches to enhance fetal imaging with MRI, in the presence of motion. As part of technical development, the investigators plan to develop methods to improve structural T1 and T2 weighted images, MR angiography, diffusion and spectroscopy measurements of the fetus.

Conditions

Pregnancy Related

Keywords

MRI; Fetus; Uterus; Placenta; Brain

Outcome Measures

Primary Outcomes (2)

• Image alignment in fetal MRI

  Evaluation of image alignment with automatical positioning in MRI

  Five year K99/R00 project

• Tracking quality in fetal MRI

  Evaluation of image quality with motion tracking in MRI

  Five year K99/R00 project

Study Arms (1)

Pregnant women presenting for MRI

Alternative motion-robust MR imaging sequences and procedures for automatic positioning while be tested during fetal brain imaging

Other: No intervention - the investigators are evaluating a new image acquisition method on an MRI scanner

Interventions

No intervention - the investigators are evaluating a new image acquisition method on an MRI scanner OTHER

The investigators will evaluate the performance of a modified MRI acquisition method against an existing method in fetal imaging in volunteers

Pregnant women presenting for MRI

Eligibility Criteria

• Age: 13 Weeks - 40 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women presenting for imaging of the fetus

You may not qualify if:

• Claustrophobia sufficient to interfere with MRI or render the subject unable to complete an MRI scan
• MRI contraindications (e.g., magnetically or mechanically activated implants)
• Weight greater than or equal to 300lbs (weight limit of the MRI table)
• Non-English speaking
• Neurological conditions (i.e. epilepsy, multiple sclerosis, neurodegenerative diseases, memory disorders, brain tumor)
• Past incidence of stroke or heart attack
• Severe hypertension, blood disorders, advanced diabetes mellitus, or advanced cardiovascular disease
• Hospitalization within 6 weeks prior to enrollment
• Significant acute and/or chronic medical conditions, current use of medications that indicate the existence of significant medical conditions, and other unspecified reasons that make the subject unsuitable for enrollment at the discretion at the PI and a consulting MD.
• Pregnant mothers with the following features will be excluded.
• Mothers with contraindication to MRI (such as pacemaker, metal in body, exceeding scanner weight or bore diameter limits (550lbs, 70cm))
• Mothers with claustrophobia
• Mothers medically unstable for the MRI study

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Central Study Contacts

Andre van der Kouwe, PhD

CONTACT

6177264704; avanderkouwe@mgh.harvard.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Andre van der Kouwe

Study Record Dates

• First Submitted: January 11, 2022
• First Posted: February 24, 2022
• Study Start: May 31, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share