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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Sheba Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01121094
First received: May 9, 2010
Last updated: May 11, 2010
Last verified: May 2010

May 9, 2010
May 11, 2010
June 2010
June 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01121094 on ClinicalTrials.gov Archive Site
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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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Iron Overload
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
50
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any MRI study for fetus

Exclusion Criteria:

  • Known iron deposition problem in the mother of fetus
Both
Not Provided
Yes
Contact: Orly Goitein, MD +972 3 5302530 orly.goitein@sheba.health.gov.il
Israel
 
NCT01121094
SHEBA-09-7502-OG-SMC
No
Sheba Medical Center
Sheba Medical Center
Not Provided
Not Provided
Sheba Medical Center
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP