Iron Overload
Conditions
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.
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.
Interventions
DEVICEGE 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
Sponsors
GE Healthcare
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Be at least ten (10) years of age; 2. Have clinical history of iron overload; 3. 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; 4. 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; 5. Be able to hear and understand instructions without assistive devices; 6. Have necessary mental capacity to understand instructions be able to comply with protocol requirements; 7. Be able to remain relatively motionless for the expected duration of imaging procedures (maximum of approximately 90 minutes).
Exclusion criteria
1. Have medical history of present or prior focal liver disease, such as neoplasms or vascular abnormalities; 2. Have contraindication(s) to MRI scanning per the routine MR Safety Screening policy of the investigational site; 3. 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; 4. 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); 5. Are minor subjects with parent(s) or legal guardian(s) that require that they accompany the subject into the MR environment; 6. Have previously participated in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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®
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 | 21 |
| Total | 21 |
Baseline characteristics
| Characteristic | MRI Imaging of Liver |
|---|---|
| Age, Categorical <=18 years | 2 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 21 |
| other Total, other adverse events | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 |
Outcome results
Primary
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.
Time frame: 48 hours pre or 24 hours post blood draw
Population: MR DICOM datasets were gathered for each enrolled subject (total of three scans per subject equals one complete dataset)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MRI Imaging of Liver | Per Subject Evaluable DICOM Data Sets From Liver MRI | 21 Participants |
Secondary
Serum Ferritin Based on Blood Draw
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
Population: Every enrolled subject
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| MRI Imaging of Liver | Serum Ferritin Based on Blood Draw | 8.3 mg FE /g dry | Standard Deviation 7.71400705 |