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

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

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.

Study Overview

• Status: Unknown
• Conditions: Iron Overload

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Orly Goitein, MD; Phone Number: +972 3 5302530; Email: orly.goitein@sheba.health.gov.il

Study Locations

• Israel
  • Tel Hashomer, Israel, 52621
    • Sheba Medical Center
    • Principal Investigator: Orly Goitein, MD
    • Contact: Orly Goitein, MD; Phone Number: +972 3 5302530

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This study will be offered to motheres undergoing fetal MRI for any indication.

Description

Inclusion Criteria:

• Any MRI study for fetus

Exclusion Criteria:

• Known iron deposition problem in the mother of fetus

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Sheba Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2010
• Primary Completion (Anticipated): June 1, 2012
• Study Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: May 9, 2010
• First Submitted That Met QC Criteria: May 11, 2010
• First Posted (Estimate): May 12, 2010

Study Record Updates

• Last Update Posted (Estimate): May 12, 2010
• Last Update Submitted That Met QC Criteria: May 11, 2010
• Last Verified: May 1, 2010

More Information

Terms related to this study

• Keywords: Liver, spleen , T2* , MRI, fetus
• Additional Relevant MeSH Terms: Metabolic Diseases; Iron Metabolism Disorders; Iron Overload
• Other Study ID Numbers: SHEBA-09-7502-OG-SMC