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| Name | Class |
|---|---|
| University of Michigan | OTHER |
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The study will be conducted at the following locations:
Investigators will prospectively compare the performance of dynamic contrast enhanced abbreviated MRI (AMRI) and contrast-enhanced ultrasound for early-stage HCC detection in patients with indeterminate liver nodules.
Investigators will prospectively perform both abbreviated MRI and contrast-enhanced ultrasound in enrolled patients every 3-6 months. Contrast-enhanced ultrasound and abbreviated MRI will preferably be done the same day, although will be permitted to be completed within 30 days of each other. Abbreviated MRI and contrast-enhanced ultrasound will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ILN Cohort | Other | Patients with LR3 observations would undergo CEUS and AMRI every 6 months; patients with LR4 observations would undergo CEUS and AMRI 3 months after enrollment and every 6 months thereafter. CEUS and AMRI will preferably be done the same day to minimize burden on the patient, although will be permitted to be completed within 14 days of each other. This interval is sufficiently short to minimize the chance of intervening events. AMRI and CEUS will be performed every 3-6 months until HCC development, regression to LR-1 or LR-2 (i.e., definitely or likely benign, respectively), or end of follow-up at 24 months post-enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CEUS imaging | Diagnostic Test | Contrast-enhanced ultrasound (CEUS) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Early HCC Detection | Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Barcelona Clinic Liver Staging system. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| HCC Detection | Evaluate TPR and FPR for any-stage HCC. | 5 years |
| Early HCC Detection | Assess and compare true positive rate (TPR) and false positive rate (FPR) of AMRI to CEUS for early-stage HCC detection, as defined by the Milan Criteria |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lisa Quirk, MS/MPH | Contact | 214-645-6179 | lisa.quirk@utsouthwestern.edu | |
| Sneha Deodhar, MS | Contact | 214-645-1378 | sneha.deodhar@utsouthwestern.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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Intervention is not masked for study team or investigator but all images are being interpreted by radiologist who is masked to clinical outcomes (development of HCC).
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| aMRI imaging |
| Diagnostic Test |
contrast enhanced abbreviated MRI (AMRI) |
|
| 5 years |
| University of Texas Southwestern Medical Center | Recruiting | Dallas | Texas | 75390 | United States |
|
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |