Hepatocellular Carcinoma
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGLumason
2.4 mL per lesion
Sponsors
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult (≥18 years of age) patients with diagnosed HCC (via imaging, biopsy, or combination of imaging and biochemical markers), who are treated with their first round of TACE. * Sex: male or female * BMI ≤ 40
Exclusion criteria
* Children (\<18), pregnant patients * Patients who do not speak English * Patients with a history of hypersensitivity reactions to sulfur hexafluoride lipid microsphere components or to any of the inactive ingredients in Lumason. * Patients with unstable cardiopulmonary conditions (acute myocardial infarction, acute coronary artery syndromes, worsening or unstable congestive heart failure, or serious ventricular arrhythmias) * Patients who have a prior non-contrast ultrasound, within last 3 months (at time of consent), where the tumor could not be seen - most commonly due to severe steatosis or obesity. * Pregnant or nursing woman * Patients who do not plan to get their follow-up CT/MRI at Hershey Medical Center.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Residual Disease on CEUS Imaging. | 2-4 months post TACE | Number of lesions with residual disease identified on CEUS imaging. Residual disease is defined as enhancement within the lesion using CEUS. |
| Residual Disease on CT/MRI Imaging | 2-4 months post-TACE | Number of lesions with residual disease identified on CT/MRI imaging. Residual disease is defined as enhancement within the lesion using CT/MRI. |
| No Viable Disease on CEUS Imaging. | 2-4 months post-TACE | Number of lesions with no viable disease identified on CEUS imaging. Non-viable disease is defined as no enhancement within the lesion using CEUS. |
| No Viable Disease on CT/MRI Imaging. | 2-4 months post-TACE | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesions Missed or Miscategorized on CEUS Imaging. | 4-8 months post-TACE | Number of lesions missed or miscategorized on CEUS imaging. |
| Lesions Missed or Miscategorized on CT/MRI Imaging. | 4-8 months post-TACE | Number of lesions missed or miscategorized on CT/MRI imaging. |
Countries
United States
Participant flow
Pre-assignment details
Diagnosis of hepatocellular carcinoma (HCC).
Participants by arm
| Arm | Count |
|---|---|
| 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 | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Group-1 | — |
|---|---|---|
| Age, Continuous | 66.6 years STANDARD_DEVIATION 7.9 | — |
| BMI | 30.5 kg/m^2 STANDARD_DEVIATION 4.9 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 7 Participants | — |
| Sex: Female, Male Male | 19 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 0 / 26 |
Outcome results
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.
Time frame: 2-4 months post-TACE
Population: Diagnosed with HCC with 1 or more lesions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | No Viable Disease on CEUS Imaging. | 12 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.
Time frame: 2-4 months post-TACE
Population: Diagnosed with HCC with 1 or more lesions
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | No Viable Disease on CT/MRI Imaging. | 16 lesions |
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.
Time frame: 2-4 months post TACE
Population: Diagnosed with HCC with 1 or more lesions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | Residual Disease on CEUS Imaging. | 19 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.
Time frame: 2-4 months post-TACE
Population: Diagnosed with HCC with 1 or more lesions.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | Residual Disease on CT/MRI Imaging | 17 lesions |
Secondary
Lesions Missed or Miscategorized on CEUS Imaging.
Number of lesions missed or miscategorized on CEUS imaging.
Time frame: 4-8 months post-TACE
Population: 3 subjects did not return for routine imaging at 4-8 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | Lesions Missed or Miscategorized on CEUS Imaging. | 2 lesions |
Secondary
Lesions Missed or Miscategorized on CT/MRI Imaging.
Number of lesions missed or miscategorized on CT/MRI imaging.
Time frame: 4-8 months post-TACE
Population: 3 subjects did not return for routine imaging at 4-8 months.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Group-1 | Lesions Missed or Miscategorized on CT/MRI Imaging. | 6 lesions |