Non-invasive Quantification of Liver Iron With MRI
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MRI imaging of liver 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® |
Device: GE Optima/Discovery® MRI data of the liver
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
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Per Subject Evaluable DICOM Data Sets From Liver MRI [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.
Secondary Outcome Measures
- Serum Ferritin Based on Blood Draw [48 hours post MR scan or 24 hours pre MR scan]
The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab).
Eligibility Criteria
Criteria
Inclusion Criteria
-
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).
Exclusion Criteria
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Wisconsin-Madison | Madison | Wisconsin | United States | 53705 |
Sponsors and Collaborators
- GE Healthcare
Investigators
- Principal Investigator: Frank Korosec, PhD, University of Wisconsin, Madison
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 114-2014-GES-0039
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | MRI Imaging of Liver |
|---|---|
| Arm/Group Description | 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® GE Optima/Discovery® MRI data of the liver: 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 |
| Period Title: Overall Study | |
| STARTED | 21 |
| COMPLETED | 21 |
| NOT COMPLETED | 0 |
Baseline Characteristics
| Arm/Group Title | MRI Imaging of Liver |
|---|---|
| Arm/Group Description | 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® GE Optima/Discovery® MRI data of the liver: 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 |
| Overall Participants | 21 |
| Age (Count of Participants) | |
| <=18 years |
2
9.5%
|
| Between 18 and 65 years |
15
71.4%
|
| >=65 years |
4
19%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
9
42.9%
|
| Male |
12
57.1%
|
Outcome Measures
| Title | Per Subject Evaluable DICOM Data Sets From Liver MRI |
|---|---|
| Description | 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. |
| Time Frame | 48 hours pre or 24 hours post blood draw |
Outcome Measure Data
| Analysis Population Description |
|---|
| MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset) |
| Arm/Group Title | MRI Imaging of Liver |
|---|---|
| Arm/Group Description | 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® GE Optima/Discovery® MRI data of the liver: 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 |
| Measure Participants | 21 |
| Count of Participants [Participants] |
21
100%
|
| Title | Serum Ferritin Based on Blood Draw |
|---|---|
| Description | The secondary outcome is collection of serum ferritin from hematologic analysis (blood draw analyzed by site central lab). |
| Time Frame | 48 hours post MR scan or 24 hours pre MR scan |
Outcome Measure Data
| Analysis Population Description |
|---|
| Every enrolled subject |
| Arm/Group Title | MRI Imaging of Liver |
|---|---|
| Arm/Group Description | 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® GE Optima/Discovery® MRI data of the liver: 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 |
| Measure Participants | 21 |
| Mean (Standard Deviation) [mg FE /g dry] |
8.3
(7.71400705)
|
Adverse Events
| Time Frame | Date collected during duration of study enrollment through completion | |
|---|---|---|
| Adverse Event Reporting Description | ||
| Arm/Group Title | MRI Imaging of Liver | |
| Arm/Group Description | 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® GE Optima/Discovery® MRI data of the liver: 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 | |
All Cause Mortality |
||
| MRI Imaging of Liver | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Serious Adverse Events |
||
| MRI Imaging of Liver | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| MRI Imaging of Liver | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/21 (0%) | |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
| Name/Title | Research Manager |
|---|---|
| Organization | GE Healthcare |
| Phone | 262-521-6819 |
| Sandhya.Parameswaran@med.ge.com |
- 114-2014-GES-0039