Status:
NOT_YET_RECRUITING
Fetal MRI Acquisition and Sequence Development
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Pregnancy Related
Eligibility:
All Genders
13-40 years
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 investigato...
Detailed Description
Fetal MRI has become a critical tool for both studying the early development of the human brain and resolving diagnostic ambiguities that may remain after routine ultrasound exams. Due to its excellen...
Eligibility Criteria
Inclusion
- Eligibility will be determined prior to the scan session by a pre-screening interview conducted either via telephone or in person asking about MR contraindications.
- Participants will be excluded from study entry or study completion when any of the following exclusion criteria are met at any time of screening or enrollment:
- 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
Exclusion
Key Trial Info
Start Date :
May 31 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05253742
Start Date
May 31 2023
End Date
May 31 2026
Last Update
January 26 2023
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