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Massive Iron Deposit Assessment

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ClinicalTrials.gov Identifier: NCT01572922
Recruitment Status : Completed
First Posted : April 6, 2012
Results First Posted : May 21, 2019
Last Update Posted : June 11, 2019
Sponsor:
Collaborators:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Regional One Health
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions Iron Overload
Excessive Body Iron Burden
Interventions Device: R2*-UTE
Device: R2*-GRE
Procedure: Liver biopsy
Enrollment 142
Recruitment Details Patients within the St. Jude Network (St. Jude Children's Research Hospital, St. Jude Domestic Affiliates, and the adult Hematology and Oncology program at the University of Tennessee Health Sciences Center) who have history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment.
Pre-assignment Details One arm study
Arm/Group Title Arm 1
Hide Arm/Group Description All eligible patients with history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment.
Period Title: Overall Study
Started 142
Completed 139
Not Completed 3
Reason Not Completed
Adverse Event             1
Protocol Violation             1
Death             1
Arm/Group Title Arm 1
Hide Arm/Group Description All eligible patients with history of 12 or more lifetime erythrocyte transfusions, and need for liver iron content assessment
Overall Number of Baseline Participants 142
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
<=18 years
85
  59.9%
Between 18 and 65 years
57
  40.1%
>=65 years
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 142 participants
15.9
(1.5 to 53.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Female
79
  55.6%
Male
63
  44.4%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Hispanic or Latino
8
   5.6%
Not Hispanic or Latino
131
  92.3%
Unknown or Not Reported
3
   2.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 142 participants
Asian
10
   7.0%
Black or African American
85
  59.9%
White
40
  28.2%
More than one race
1
   0.7%
Unknown or Not Reported
6
   4.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 142 participants
142
 100.0%
1.Primary Outcome
Title Hepatic Iron Content in the Liver Using Liver Biopsy
Hide Description Hepatic iron content in the liver using liver biopsy
Time Frame up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: mcg
19.8
(0.1 to 45.0)
2.Primary Outcome
Title MRI-derived R2* Values Using 1.5T UTE Technique
Hide Description Hepatic iron content of the liver using MRI-derived 1.5T R2*-UTE measurement, with results in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every "picture taken", this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver.
Time Frame Up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement.
Overall Number of Participants Analyzed 41
Median (Full Range)
Unit of Measure: Hz
864.4
(45.4 to 2245.5)
3.Secondary Outcome
Title MRI-derived R2* Using 1.5T GRE Technique
Hide Description MRI-derived R2* Using 1.5T GRE Technique in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every "picture taken", this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver.
Time Frame Up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Iron-overloaded patients had 1.5T R2*-GRE measurements.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Iron-overloaded patients defined as having more than 12 transfusions in their lifetime as measured with R2* using 1.5T GRE.
Overall Number of Participants Analyzed 139
Median (Full Range)
Unit of Measure: Hz
333.8
(33.6 to 2726.3)
4.Secondary Outcome
Title MRI Derived R2* Using 1.5T UTE Technique
Hide Description MRI-derived R2* value using 1.5T R2*-UTE in Hz. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every "picture taken", this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver.
Time Frame up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Iron-overloaded patients had 1.5T R2*-UTE-measurement.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Iron-overloaded patients with R2* using 1.5T UTE
Overall Number of Participants Analyzed 139
Median (Full Range)
Unit of Measure: HZ
319.2
(45.2 to 2245.5)
5.Secondary Outcome
Title R2* Using 1.5T UTE Technique for Patients With Serum Iron and Transferrin Saturation Measurements
Hide Description MRI-derived R2* value using 1.5T R2*-UTE in Hz for patients who have had serum iron and transferrin saturation measurements. R2* is a measure obtained with MRI, i.e., MRI R2*. It is measured in hertz (Hz). In lay terms, the MRI machine picks up a signal back from the tissue during the process of scanning the tissues. With every "picture taken", this signal is strong in the beginning and then wanes off. R2* reflects how fast the signal wanes off. If there is too much iron in the tissue, the signal disappears faster, making the T2* value low. T2* is the reciprocal of R2* (R2*= 1/T2*). So, if the signal drops fast, the T2* is low and the R2* is high. In this study, we are measuring the R2* value. The higher the R2*, the more iron in the liver tissue. We can compare the R2* value with that of a liver biopsy to then use the R2* value to tell us how much iron is in the liver without having to biopsy the liver.
Time Frame Up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
1.5T R2*-UTE from eligible patients who had 1.5T R2*-UTE, serum iron, and transferrin saturation measurements.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Iron-overloaded patients with R2* using 1.5T UTE
Overall Number of Participants Analyzed 104
Median (Full Range)
Unit of Measure: Hz
340.8
(45.2 to 2245.5)
6.Secondary Outcome
Title Serum Iron Measurements Compared With 1.5T R2* UTE
Hide Description Serum iron measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Time Frame Up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Iron-overloaded patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Arm/Group Title Serum Iron Measurements
Hide Arm/Group Description:
Serum iron measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Overall Number of Participants Analyzed 104
Median (Full Range)
Unit of Measure: ug/dL
156.5
(35 to 311)
7.Secondary Outcome
Title Transferrin Saturation Measurements
Hide Description Iron Transferrin Saturation in % measurements Transferrin Saturation measurements from eligible patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Time Frame Up to 30 days after MRI
Hide Outcome Measure Data
Hide Analysis Population Description
Iron-overloaded patients had 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description:
Iron-overloaded patients with 1.5T R2*-UTE and serum iron and transferrin saturation measurements.
Overall Number of Participants Analyzed 104
Median (Full Range)
Unit of Measure: percentage
71
(12 to 157)
Time Frame Time frame for adverse event reporting is 10 days following the last study procedure for eligible patients.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Iron-overloaded Patients
Hide Arm/Group Description Eligible iron-overloaded patients with both liver biopsy measurement and 1.5T R2*-UTE measurement
All-Cause Mortality
Iron-overloaded Patients
Affected / at Risk (%)
Total   1/142 (0.70%)    
Hide Serious Adverse Events
Iron-overloaded Patients
Affected / at Risk (%) # Events
Total   1/142 (0.70%)    
Gastrointestinal disorders   
Infections and infestations   1/142 (0.70%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Iron-overloaded Patients
Affected / at Risk (%) # Events
Total   2/142 (1.41%)    
Gastrointestinal disorders   
abdominal pain   1/142 (0.70%)  1
Psychiatric disorders   
Anxiety   1/142 (0.70%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Jane Hankins, MD
Organization: St. Jude Children's Research Hospital
Phone: 866-278-5833
EMail: Jane.Hankins@stjude.org
Layout table for additonal information
Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT01572922    
Other Study ID Numbers: MIDAS
R01DK088988 ( U.S. NIH Grant/Contract )
First Submitted: April 3, 2012
First Posted: April 6, 2012
Results First Submitted: March 1, 2019
Results First Posted: May 21, 2019
Last Update Posted: June 11, 2019