Confounder-Corrected Quantitative MRI Biomarker of Hepatic Iron Content
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| ClinicalTrials.gov Identifier: NCT02025543 |
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Recruitment Status :
Recruiting
First Posted : January 1, 2014
Last Update Posted : November 8, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Iron Overload Hemochromatosis Hemosiderosis | Device: MRI |
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.
| Study Type : | Observational |
| Estimated Enrollment : | 220 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Confounder-Corrected Quantitative Magnetic Resonance Imaging (MRI) Biomarker of Hepatic Iron Content |
| Actual Study Start Date : | August 12, 2015 |
| Estimated Primary Completion Date : | March 24, 2023 |
| Estimated Study Completion Date : | March 2024 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patient Group
Subjects with known or suspected iron overload will undergo serum ferritin measurement and an MRI scan.
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Device: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging |
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Control Group
Subjects with no known history of iron overload or liver disease will undergo an MRI scan.
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Device: MRI
R2 MRI scan
Other Name: Magnetic Resonance Imaging |
- Calibration curve of liver R2* vs LIC measured by Ferriscan at each of the sites [ Time Frame: 1 year ]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.
- Precision: Difference in UW-measured R2* vs Average [ Time Frame: 2 years ]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.
- Diagnostic Accuracy [ Time Frame: 2 years ]In addition to correlation with liver iron concentration (technical accuracy), the diagnostic accuracy through receiver operator characteristic curve analysis will also be determined.
- Robustness Assessed via Linear Mixed Effects Regression [ Time Frame: 2 years ]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.
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| Ages Eligible for Study: | 8 Years to 89 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- know or suspected iron overload
- minimum age: Stanford- 8years , University of Wisconsin - 10 years, John Hopkins follow- 10 years, University of Texas-Southwestern - 18 years
Exclusion Criteria:
- contraindication to magnetic resonance imaging
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02025543
| Contact: Scott Reeder, MD, PhD | 608-265-9964 | sreeder@uwhealth.org | |
| Contact: Diego Hernando, PhD | 608-265-7590 | dhernando@uwhealth.org |
| United States, California | |
| Stanford University | Active, not recruiting |
| Palo Alto, California, United States, 94087 | |
| United States, Maryland | |
| Johns Hopkins University | Active, not recruiting |
| Baltimore, Maryland, United States, 21218 | |
| United States, Texas | |
| University of Texas-Southwestern | Active, not recruiting |
| Dallas, Texas, United States, 75390 | |
| United States, Wisconsin | |
| University of Wisconsin, Madison | Recruiting |
| Madison, Wisconsin, United States, 53704 | |
| Contact: Gemma Gliori, MS 608-262-7269 ggliori@uwhealth.org | |
| Contact: Suzanne Hanson, BS 608-263-7421 shanson@uwhealth.org | |
| Principal Investigator: Scott Reeder, MD, PhD | |
| Principal Investigator: | Scott Reeder | University of Wisconsin, Madison |
| Responsible Party: | University of Wisconsin, Madison |
| ClinicalTrials.gov Identifier: | NCT02025543 |
| Other Study ID Numbers: |
2013-1174 A539300 ( Other Identifier: UW Madison ) SMPH/RADIOLOGY/RADIOLOGY* ( Other Identifier: UW Madison ) R01DK100651 ( U.S. NIH Grant/Contract ) |
| First Posted: | January 1, 2014 Key Record Dates |
| Last Update Posted: | November 8, 2022 |
| Last Verified: | November 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | Yes |
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MRI Iron overload |
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Hemochromatosis Iron Overload Hemosiderosis Iron Metabolism Disorders |
Metabolic Diseases Metal Metabolism, Inborn Errors Metabolism, Inborn Errors Genetic Diseases, Inborn |