Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences

NCT ID: NCT01121094

Last Updated: 2010-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-06-30

Brief Summary

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The purpose of this study is to prospectively evaluated the T2\* values of normal feti.A standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Detailed Description

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The purpose of this study is to prospectively evaluate the T2\* values of normal feti. This study will be offered to mothers undergoing fetal MRI for any indication. Subjects will be required to sign an informed consent from. The addition of T2\* sequences will add 2-4 minutes to the whole scan, not exposing the mother or the fetus to ionizing radiation or the administration of contrast material. A standardized scale has been created and multi-center studies have been conducted using different vendor scanners in order to verify the consistency of these scale. T2 and T2\* sequences have been addressed anecdotally in the literature as non invasive options for the evaluation fetal iron deposition . However, a standardized scale of T2\* values for fetal and neonatal iron organ overload have yet to be reported or devised.

Conditions

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Iron Overload

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Any MRI study for fetus

Exclusion Criteria

* Known iron deposition problem in the mother of fetus
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheba Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Sheba Medical Center

Locations

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Sheba medical center

Tel Litwinsky, Israel, Israel

Site Status

Countries

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Israel

Central Contacts

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Orly Goitein, MD

Role: CONTACT

+972 3 5302530

Facility Contacts

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Orly Goitein, MD

Role: primary

+972 3 5302530

Other Identifiers

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SHEBA-09-7502-OG-SMC

Identifier Type: -

Identifier Source: org_study_id

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