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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2010 by Sheba Medical Center.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01121094
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sheba Medical Center
  Purpose
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.

Condition
Iron Overload

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.

Resource links provided by NLM:


Further study details as provided by Sheba Medical Center:

Estimated Enrollment: 50
Study Start Date: June 2010
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
This study will be offered to motheres undergoing fetal MRI for any indication.
Criteria

Inclusion Criteria:

  • Any MRI study for fetus

Exclusion Criteria:

  • Known iron deposition problem in the mother of fetus
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121094


Contacts
Contact: Orly Goitein, MD +972 3 5302530 orly.goitein@sheba.health.gov.il

Locations
Israel
Sheba medical center Not yet recruiting
Tel Hashomer, Israel, 52621
Contact: Orly Goitein, MD    +972 3 5302530      
Principal Investigator: Orly Goitein, MD         
Sponsors and Collaborators
Sheba Medical Center
  More Information

Responsible Party: Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01121094     History of Changes
Other Study ID Numbers: SHEBA-09-7502-OG-SMC
First Submitted: May 9, 2010
First Posted: May 12, 2010
Last Update Posted: May 12, 2010
Last Verified: May 2010

Keywords provided by Sheba Medical Center:
Liver, spleen , T2* , MRI, fetus

Additional relevant MeSH terms:
Iron Overload
Iron Metabolism Disorders
Metabolic Diseases