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The purpose of this research study is to find out if a different type of imaging study called contrast enhanced ultrasound (CEUS) is as good as, or better than CT or MRI in patients diagnosed with hepatocellular carcinoma (HCC) after receiving TACE treatment
This is a prospective trial to determine if contrast enhanced ultrasound (CEUS) is non-inferior to CT or MRI in patients with hepatocellular carcinoma (HCC) following transcatheter arterial chemoembolization(TACE) treatments. All patients will receive standard of care CT/MRI and will also get a contrast ultrasound to directly compare.
Timepoint 0- Our proposed study population includes subjects with diagnosed HCC, who are treated with TACE. Patients will be identified and enrolled at the time of initial TACE.
Timepoint 1- Following initial TACE, patients will receive a CT or MRI, as routinely ordered in the post-TACE setting, to assess for residual or new HCC. At this same imaging follow-up visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS). Timepoint 2- Per standard clinical care, patients typically return for repeat imaging (CT/MRI) within 2-4 months following the first imaging visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group-1 | Other | Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumason | Drug | 2.4 mL per lesion |
|
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| Measure | Description | Time Frame |
|---|---|---|
| Residual Disease on CEUS Imaging. | Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS. | 2-4 months post TACE |
| Residual Disease on CT/MRI Imaging | Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI. | 2-4 months post-TACE |
| No Viable Disease on CEUS Imaging. | Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS. | 2-4 months post-TACE |
| No Viable Disease on CT/MRI Imaging. | Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI. | 2-4 months post-TACE |
| Measure | Description | Time Frame |
|---|---|---|
| Lesions Missed or Miscategorized on CEUS Imaging. | Number of lesions missed or miscategorized on CEUS imaging. | 4-8 months post-TACE |
| Lesions Missed or Miscategorized on CT/MRI Imaging. | Number of lesions missed or miscategorized on CT/MRI imaging. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathryn McGillen | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
Diagnosis of hepatocellular carcinoma (HCC).
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| ID | Title | Description |
|---|---|---|
| FG000 | Group-1 | Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Group-1 | Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Residual Disease on CEUS Imaging. | Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS. | Diagnosed with HCC with 1 or more lesions. | Posted | Number | lesions | 2-4 months post TACE | lesions | lesions |
|
Up to 8 months (length of time subjects were on study)
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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 | Group-1 | Following treatment, patients will receive their standard CT or MRI, as routinely ordered in the post-TACE setting. This imaging will be per standard protocol, as directed by hepatology or oncology services, often 2 to 4 months after the treatment. At the same visit, patients will also receive a one-time additional contrast-enhanced ultrasound (CEUS), Lumason: 2.4 mL per lesion |
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Small sample number, pilot study
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kathryn McGillen, M.D. | Penn State Health College of Medicine | 717-531-0003 | kmcgillen@pennstatehealth.psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 3, 2021 | Sep 12, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 3, 2021 | Sep 12, 2023 | ICF_001.pdf |
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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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| ID | Term |
|---|---|
| C420843 | contrast agent BR1 |
| D013459 | Sulfur Hexafluoride |
| ID | Term |
|---|---|
| D005459 | Fluorides |
| D006858 | Hydrofluoric Acid |
| D017611 | Fluorine Compounds |
| D007287 | Inorganic Chemicals |
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| 4-8 months post-TACE |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
| lesions |
|
|
| Primary | Residual Disease on CT/MRI Imaging | Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI. | Diagnosed with HCC with 1 or more lesions. | Posted | Number | lesions | 2-4 months post-TACE | lesions | lesions |
|
|
|
| Primary | No Viable Disease on CEUS Imaging. | Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS. | Diagnosed with HCC with 1 or more lesions. | Posted | Number | lesions | 2-4 months post-TACE | lesions | lesions |
|
|
|
| Primary | No Viable Disease on CT/MRI Imaging. | Number of lesions with no viable disease identified on CT/MRI imaging. Non-viable disease is defined as no enhancement within the lesion using CT/MRI. | Diagnosed with HCC with 1 or more lesions | Posted | Number | lesions | 2-4 months post-TACE | lesions | lesions |
|
|
|
| Secondary | Lesions Missed or Miscategorized on CEUS Imaging. | Number of lesions missed or miscategorized on CEUS imaging. | 3 subjects did not return for routine imaging at 4-8 months. | Posted | Number | lesions | 4-8 months post-TACE | lesions | lesions |
|
|
|
| Secondary | Lesions Missed or Miscategorized on CT/MRI Imaging. | Number of lesions missed or miscategorized on CT/MRI imaging. | 3 subjects did not return for routine imaging at 4-8 months. | Posted | Number | lesions | 4-8 months post-TACE | lesions | lesions |
|
|
|
| 0 |
| 26 |
| 0 |
| 26 |
| 0 |
| 26 |
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| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
| D005740 |
| Gases |
| D013457 | Sulfur Compounds |