Iron OverloadNCT01121094
Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences
An observational study of Iron Overload, run by Sheba Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Iron Overload
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- Jun 2010to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: This study will be offered to motheres undergoing fetal MRI for any indication.
Who may be able to join
- Any MRI study for fetus
Who cannot join
- Known iron deposition problem in the mother of fetus
Trial locations and contacts
1 site in 1 country.
Israel1 site
Sheba medical center
Tel HaShomer, Israel, 52621
Orly Goitein, MD, +972 3 5302530
Orly Goitein, MD
About this study
Official title: 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.
Read the 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.
- Conditions
- Iron Overload
- Keywords
- Liver, spleen , T2* , MRI, fetus
- Medical subject headings
- Iron Overload
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2012 (estimated)
- Study completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Iron OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01121094
- Sponsor's protocol ID
- SHEBA-09-7502-OG-SMC
- Status last verified
- May 2010
- First submitted
- 9 May 2010
- Last updated
- 12 May 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Parenchymatic Evaluation (Liver, Spleen) Using T2* Sequences.
- ClinicalTrials.gov ID
- NCT01121094
- Acronym / sponsor ID
- SHEBA-09-7502-OG-SMC
- Conditions
- Iron Overload
- Keywords
- Liver, spleen , T2* , MRI, fetus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- Jun 2010
- Primary completion
- Jun 2012 (estimated)
- Study completion
- Jun 2012 (estimated)
- First posted
- 12 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This study will be offered to motheres undergoing fetal MRI for any indication.
Key inclusion criteria (1 listed)
- Any MRI study for fetus
Key exclusion criteria (1 listed)
- Known iron deposition problem in the mother of fetus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Iron Overload, run by Sheba Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orly Goitein, MD (+972 3 5302530, orly.goitein@sheba.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2010.