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NCT01121094 Clinical Trial

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

Iron Overload Clinical Trial

Official title:
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT01121094
Other study ID # SHEBA-09-7502-OG-SMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received May 9, 2010
Last updated May 11, 2010
Start date June 2010
Est. completion date June 2012

Study information
Verified date May 2010
Source Sheba Medical Center
Contact Orly Goitein, MD
Phone +972 3 5302530
Email orly.goitein@sheba.health.gov.il
Is FDA regulated No
Health authority Israel: Israeli Health Ministry Pharmaceutical Administration
Study type Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Any MRI study for fetus

Exclusion Criteria:

- Known iron deposition problem in the mother of fetus

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba medical center Tel Hashomer

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

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