Iron OverloadNCT02425956

Non-invasive Quantification of Liver Iron With MRI

A study testing GE Optima/Discovery® MRI data of the liver in people with Iron Overload, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 10 years and older
Conditions the study is for: Iron Overload
What is being tested?: GE Optima/Discovery® MRI data of the liver
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Apr 2015to 30 Jun 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 10 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Be at least ten (10) years of age;
Have clinical history of iron overload;
If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures;
Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation;
Be able to hear and understand instructions without assistive devices;
Have necessary mental capacity to understand instructions be able to comply with protocol requirements;
Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes).

Who cannot join

Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities;
Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct;
Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first);
Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment;
Have previously participated in this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin-Madison
Madison, Wisconsin, 53705

Other trials in United States

About this study

Read the detailed description

This study is being conducted to build a library of prospectively collected clinical data from subjects with iron overload examined with commercially available MRI devices. This data library is intended for use in future engineering development and other research activities, including future regulatory submissions. Data from human subjects is required to develop and test Magnetic resonance (MR) reconstruction techniques that can provide quantitative information about tissue properties, such as volumetric fat and iron concentrations. Collection of MR data and corresponding quantitative liver iron concentration (LIC) data is necessary for development of MR techniques that can show both overall and regional iron concentrations of in vivo tissues. These techniques may provide viable alternatives to invasive and expensive conventional liver biopsy and to less accurate serum biomarker testing, potentially benefiting future clinical patients with iron overload.

MR image data and corresponding quantitative data about serum and liver iron levels will be collected from each subject in this study. These datasets are considered suitable for future development and testing of MR reconstruction software, including MR reconstruction algorithms developed by General Electric Healthcare (GEHC) to use Longitudinal relaxation rate equal to the reciprocal of T2 relaxation time (1/T2) (R2) techniques to assess LIC. To achieve a sufficiently diverse library for future testing, MRI data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GEHC IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan® Specialized Reconstruction Service guidelines (Resonance Health, Claremont, AU). Quantitative hematologic (serum ferritin) based on blood testing and FerriScan® Analysis Service LIC reports will be collected for each subject.

Conditions: Iron Overload
Being tested: GE Optima/Discovery® MRI data of the liver
Medical subject headings: Iron Overload

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GE Optima/Discovery® MRI data of the liverDevice
Also called GE Optima/Discovery® MRI, FerriScan® (Resondence Health), GE IDEAL IQ®
GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer

Study groups in NCT02425956
Study group	Role	What they receive
MRI imaging of liver	Experimental	GE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan® Receives: Device: GE Optima/Discovery® MRI data of the liver

What is being measured

The primary outcome is the main question the study is designed to answer.

Per Subject Evaluable DICOM Data Sets From Liver MRI
The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.
Measured: 48 hours pre or 24 hours post blood draw

Secondary outcomes (1)

Serum Ferritin Based on Blood Draw
The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).
Measured: 48 hours post MR scan or 24 hours pre MR scan

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 201530 Jun 2016

First posted24 Apr 2015 (estimated)
Study startApr 2015
Primary completion30 Jun 2016
Study completion30 Jun 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Iron OverloadStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
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: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02425956
Sponsor's protocol ID: 114-2014-GES-0039
Status last verified: Jun 2017
First submitted: 16 Mar 2015
Last updated: 24 Jul 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
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Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia

All Iron Overload trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Non-invasive Quantification of Liver Iron With MRI
ClinicalTrials.gov ID: NCT02425956
Acronym / sponsor ID: 114-2014-GES-0039
Conditions: Iron Overload
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: Apr 2015
Primary completion: 30 Jun 2016 (actual)
Study completion: 30 Jun 2016 (actual)
First posted: 24 Apr 2015 (estimated)
Results: Posted 24 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
MRI imaging of liver	Experimental	Device: GE Optima/Discovery® MRI data of the liverGE Optima/Discovery® MRI imaging data of the liver and surrounding tissues will be acquired using 1.5T and 3.0T GE Healthcare (GEHC) IDEAL IQ scans and commercially available 1.5T MRI scans conducted according to the FerriScan®

Who may qualify

Ages: 10 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (7 listed)

Be at least ten (10) years of age;
Have clinical history of iron overload;
If female of childbearing potential (not surgically sterile or post-menopausal), be determined non-pregnant by the medical co-investigator and/or a delegated physician on the study staff or are demonstrated non-pregnant by negative urine pregnancy test administered within the 24 hour period before participating in study procedures;
Provide evidence of willingness to participate by providing written informed consent to participate OR, if aged less than 18 years (<18) be willing to provide written assent to participate and have parent(s) or legal guardian(s) willing to provide written informed consent for the subject's participation;
Be able to hear and understand instructions without assistive devices;

Key exclusion criteria (6 listed)

Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities;
Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site;
Are scheduled for surgery, changes in dosage or type of chelating medications, or other medical interventions in between blood draw and MRI scanning that could be expected to impact study results or conduct;
Have had or plan to have a change in dosage or type of chelating medications (such as Deferoxamine or Deferasirox) within the 3 days prior to the first study procedure (blood draw or MRI, whichever comes first);
Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
GE Optima/Discovery® MRI data of the liverAlso: GE Optima/Discovery® MRI, FerriScan® (Resondence Health), GE IDEAL IQ®GE Optima 1.5T®/Discovery 3.0T® MRI data scanning data of the liver and surrounding tissues will be acquired using both field strengths for GE IDEAL IQ® and single field strength with FerriScan® (Resondence Health) Specialized Reconstruction Service, according instructions provided by manufacturer	Device	MRI imaging of liver

Primary outcome

Per Subject Evaluable DICOM Data Sets From Liver MRI
Time frame: 48 hours pre or 24 hours post blood draw
The primary outcome measure is collection of evaluable (based on physician determination) MR DICOM datasets including valid 1.5 and 3.0T image data, P-file, R2* maps, and raw data for each enrolled subject. The datasets were gathered via three independent MR scans conducted within a three hour time block, with up to ten minutes break in between.

1 secondary outcome

Serum Ferritin Based on Blood Draw
Time frame: 48 hours post MR scan or 24 hours pre MR scan

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MRI Imaging of Liver	21	21

Primary outcome: Per Subject Evaluable DICOM Data Sets From Liver MRI

Time frame: 48 hours pre or 24 hours post blood draw. Count of participants. Unit: Participants

Measure	MRI Imaging of Liver n = 21
Value	21

Population analysed: MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Date collected during duration of study enrollment through completion. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MRI Imaging of Liver	0 of 21 (0%)	0 of 21 (0%)	0 of 21

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Iron Overload

Active, not recruitingPhase 2
Treatment of Hemochromatosis
Hemochromatosis
Active, not recruitingObservational study
Ethnic Differences in Iron Absorption (FeGenes)
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingObservational study
Heme and Non-heme Iron Intakes, Gut Microbiota, and Influence on Host Iron Absorption
Anemia, Iron Deficiency, Iron Overload
Active, not recruitingPhase 2
Efficacy and Safety of Vamifeport in Adult Participants With Homeostatic Iron Regulator Gene (HFE)-Related Hereditary Hemochromatosis
Homeostatic Iron Regulator Gene-related Hereditary Hemochromatosis
Not yet recruitingObservational study
Native T1 Mapping and ECV in Chronic Hemolytic Anemia
Hemolytic Anemia, Thalassemia

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.

Frank Korosec, PhD principal investigator

University of Wisconsin, Madison

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing GE Optima/Discovery® MRI data of the liver in people with Iron Overload, run by GE Healthcare at 1 site in United States.

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 7 inclusion and 6 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: finished, as of the sponsor's last update on 24 Jul 2017. 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 United States. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Per Subject Evaluable DICOM Data Sets From Liver MRI (time frame: 48 hours pre or 24 hours post blood draw). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02425956.

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 24 Jul 2017.