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| ID | Type | Description | Link |
|---|---|---|---|
| JT 2999 | Other Identifier | JeffTrial Number |
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This pilot clinical trial compares the use of contrast-enhanced ultrasound to contrast-enhanced magnetic response imaging (MRI), the current clinical standard, in predicting treatment response in patients with liver cancer receiving transarterial chemoembolization with drug eluting beads. Comparing results of diagnostic procedures before and after transarterial chemoembolization may help doctors predict a patient's response to treatment and help plan the best treatment. It is not yet known if contrast-enhanced ultrasound works better than contrast-enhanced MRI in predicting treatment response in patients with liver cancer.
PRIMARY OBJECTIVES:
I. Evaluate if contrast-enhanced ultrasound of hepatocellular carcinomas at one to two weeks and one month correlate with the clinical evaluation standard of a contrast-enhanced MRI at one month (the current clinical standard) in patients who have undergone transarterial chemoembolization with drug eluting beads.
SECONDARY OBJECTIVES:
I. Establish whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic (contrast-enhanced ultrasound) | Experimental | Patients receive perflutren lipid microspheres IV and then undergo contrast-enhanced ultrasound imaging over approximately 1 hour prior to transarterial chemoembolization with drug eluting beads, at 1-2 weeks and 1 month post transarterial chemoembolization with drug eluting beads. Patients also undergo contrast-enhanced MRI at 1 month post-treatment per standard of care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Perflutren Lipid Microspheres | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ability of contrast-enhanced ultrasound to predict response to transarterial chemoembolization with drug eluting beads | Contrast-enhanced ultrasound of hepatocellular carcinomas at one month will be evaluated to see if it correlates with the clinical evaluation standard of a contrast-enhanced MRI at one month. Sensitivity, specificity, accuracy, positive predictive value, and negative predictive value will be calculated for the contrast-enhanced ultrasound exam. Correlations between these findings and both contrast-enhanced MRI findings and patient outcomes will be compared using the Fisher exact test. Inter- and intra-observer variability will also be calculated. | Up to 1 month after transarterial chemoembolization |
| Measure | Description | Time Frame |
|---|---|---|
| Change in quantitative blood flow parameters | Whether changes in quantitative blood flow parameters relative to baseline correlate with effective embolization will be established. | Baseline to up to 1 month after transarterial chemoembolization |
| Quantitative parameters of tumor vascularity |
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Inclusion Criteria:
Exclusion Criteria:
Females who are pregnant or nursing
Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable; for example:
Patients with recent cerebral hemorrhage
Patients with clinically significant and unstable renal disease (eg, transplant recipients in rejection)
Patients who have undergone surgery within 24 hours prior to the study sonographic examination
Patients with known hypersensitivity to perflutren
Patients who have received any contrast medium (x-ray, MRI, computed tomography [CT], or ultrasound [US]) in the 24 hours prior to the research US exam
Patients with cardiac shunts
Patients with congenital heart defects
Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
Patients with respiratory distress syndrome
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| Name | Affiliation | Role |
|---|---|---|
| Flemming Forsberg, PhD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
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| Label | URL |
|---|---|
| Sidney Kimmel Cancer Center | View source |
| Thomas Jefferson University Hospital | View source |
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| Dynamic Contrast-Enhanced Ultrasound Imaging | Device | Undergo contrast-enhanced ultrasound imaging |
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| Contrast-enhanced Magnetic Resonance Imaging | Device | Undergo contrast-enhanced Magnetic Resonance Imaging |
|
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| Baseline to up to 1 month after transarterial chemoembolization |
| Changes in perfusion | Baseline to up to 1 month after transarterial chemoembolization |
| Changes in contrast fill time | Baseline to up to 1 month after transarterial chemoembolization |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C042852 | perflutren |
| D000098543 | Dynamic Contrast Enhanced Magnetic Resonance Imaging |
| ID | Term |
|---|---|
| D008279 | Magnetic Resonance Imaging |
| D014054 | Tomography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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