Not provided
Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| A539300 | Other Identifier | UW Madison | |
| SMPH/RADIOLOGY/RADIOLOGY* | Other Identifier | UW Madison | |
| R01DK100651 | U.S. NIH Grant/Contract | View source | |
| Protocol Version 12/12/22 | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Johns Hopkins University | OTHER |
| Stanford University | OTHER |
| University of Texas | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Not provided
Not provided
Not provided
Not provided
The purpose of this multi-site research is to validate a rapid magnetic resonance based confounder-corrected R-2 mapping method as a quantitative imaging biomarker of liver iron concentrations.
This multi-center, multi-vendor study will validate a rapid magnetic resonance-based confounder-corrected R2* mapping method as a quantitative imaging biomarker of liver iron concentration (LIC). Excessive accumulation of iron in various organs, including the liver, which affects both adult and pediatric populations, is toxic and requires treatment aimed at reducing body iron stores. Measurement of LIC is critical for detection and staging of iron overload, and for monitoring iron-reducing chelator therapies that are expensive and have side effects. Magnetic Resonance Imaging (MRI) is a widely available, accessible, and safe technology, and it is very sensitive to the presence of iron in tissue. Translation of an MRI biomarker of liver iron concentration into broad clinical use requires that it is clinically feasible, precise, robust to changes in scan parameters, calibrated to a validated reference standard of LIC, and is reproducible across sites and manufacturers. There are currently no available MRI methods that meet these requirements. R2*-MRI holds the greatest promise to meet these requirements. R2* mapping can be performed very rapidly with whole-liver 3D coverage in a single 20s breath-hold.
Protocol Modification approved to include additional liver susceptibility measurements for approximately 10 participants (already enrolled at the UW) via recently acquired Superconducting Quantum Interference Device (SQUID). The completion of this additional imaging will depend upon the successful set up and installation of this device.
Per a protocol amendment approved on 10/11/21, the investigators are re-opening the study and increasing enrollment for control subjects. Up to 20 control subjects (changed from 5) will be enrolled.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patient Group | Subjects with known or suspected iron overload will undergo serum ferritin measurement and an MRI scan. |
| |
| Control Group | Subjects with no known history of iron overload or liver disease will undergo an MRI scan. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | R2 MRI scan |
|
| Measure | Description | Time Frame |
|---|---|---|
| Calibration curve of liver R2* vs LIC measured by Ferriscan at each of the sites | The hypothesis is that equivalence between R2 measured with different protocols with higher repeatability than standard MRI iron imaging measurement and with linear calibration to liver iron concentration will be demonstrated. This project will be considered a success if the reproducibility of confounder-corrected R2 MRI is established: the hypothesis is that calibrations at all sites will be equivalent. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Precision: Difference in UW-measured R2* vs Average | Repeat scans will be used at each site to determine precision of R2 liver iron concentration. Repeat scans on n=25 subjects per site will be used to determine Bland-Altman 95% limits of agreement (LOA) by plotting the difference in UW-measured R2* vs average. | 2 years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Participants with known or suspected iron overload, plus a control cohort
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Scott Reeder | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94087 | United States | ||
| Johns Hopkins University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36194113 | Result | Hernando D, Zhao R, Yuan Q, Aliyari Ghasabeh M, Ruschke S, Miao X, Karampinos DC, Mao L, Harris DT, Mattison RJ, Jeng MR, Pedrosa I, Kamel IR, Vasanawala S, Yokoo T, Reeder SB. Multicenter Reproducibility of Liver Iron Quantification with 1.5-T and 3.0-T MRI. Radiology. 2023 Feb;306(2):e213256. doi: 10.1148/radiol.213256. Epub 2022 Oct 4. | |
| 39238238 | Derived | Buelo CJ, Velikina J, Mao L, Zhao R, Yuan Q, Ghasabeh MA, Ruschke S, Karampinos DC, Harris DT, Mattison RJ, Jeng MR, Pedrosa I, Kamel IR, Vasanawala S, Yokoo T, Reeder SB, Hernando D. Multicenter, multivendor validation of liver quantitative susceptibility mapping in patients with iron overload at 1.5 T and 3 T. Magn Reson Med. 2025 Jan;93(1):330-340. doi: 10.1002/mrm.30251. Epub 2024 Sep 5. |
Not provided
Not provided
Case report forms will be coded with a unique study identification number and sent to with the coordinating center by courier. Images will be shared shared using secure FTP server.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D019190 | Iron Overload |
| D006432 | Hemochromatosis |
| D006486 | Hemosiderosis |
| ID | Term |
|---|---|
| D019189 | Iron Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D008664 | Metal Metabolism, Inborn Errors |
Not provided
Not provided
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
Not provided
Not provided
| NIH |
Not provided
Not provided
Not provided
| Diagnostic Accuracy |
In addition to correlation with liver iron concentration (technical accuracy), the diagnostic accuracy through receiver operator characteristic curve analysis will also be determined. |
| 2 years |
| Robustness Assessed via Linear Mixed Effects Regression | At each site and field strength, R2* measurements from the eight different protocols will be compared to assess robustness. Robustness will be assessed via linear mixed effects regression. | 2 years |
| Baltimore |
| Maryland |
| 21218 |
| United States |
| University of Texas-Southwestern | Dallas | Texas | 75390 | United States |
| University of Wisconsin, Madison | Madison | Wisconsin | 53704 | United States |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |