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Change of research focus
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MRI & MRE in infants
The purpose of the present pilot study is to determine the feasibility of using MRI and MRE to evaluate the liver in infants with suspected liver disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MRI with MRE | Experimental | Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI with MRE | Device | Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population | To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Merhar, MD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | MRI With MRE | Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Study closed due to low enrollment. The two participants that were enrolled did not have their data analyzed.
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| ID | Title | Description |
|---|---|---|
| BG000 | MRI With MRE | Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Feasibility of MRE to Provide Evaluable Images That Illustrate the Stiffness of Liver Parenchyma in an Infant Population | To determine the feasibility of MRE to provide evaluable images that illustrate the stiffness of liver parenchyma in an infant population. | There were too few eligible candidates that clinically would benefit enough to justify the potential risk of being removed from the unit and undergoing MRE in a Radiology department scanner, so the study was terminated with only 2 patients enrolled. | Posted | 12 months |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | MRI With MRE | Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device MRI with MRE: Magnetic Resonance Imaging with Magnetic Resonance Elastography using the GE MR Touch device |
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Due to difficulty with finding neonates who met the inclusion/exclusion criteria who were safe to leave the NICU and go to the Radiology department, the study was terminated and data from the 2 participants enrolled was not analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stephanie Merhar | Cincinnati Children's Hospital | 513-803-5180 | stephanie.merhar@cchmc.org |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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Magnetic resonance elastography on infants with suspected liver disease
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|
| Age, Continuous | months |
| Sex: Female, Male |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. |
| Region of Enrollment | participants |
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| Units | Counts |
|---|---|
| Participants |
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
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