Liver Neoplasms
Conditions
Keywords
liver cancer
Brief summary
The purpose of this study is to determine the efficacy of the Definity (perflutren lipid microsphere Injectable Suspension) ultrasound contrast agent in identifying small tumors (hepatomas & metastases) within the liver. Primary objective: To estimate the increase in conspicuity of small intrahepatic tumors with contrast-enhanced sonography Secondary Objectives: To estimate the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography
Detailed description
An estimated 75 patients (age 18 years of age or older) will be enrolled from the population of patients who present for ultrasound-guided radiofrequency ablation (RFA) of CT or MRI-confirmed multiple primary hepatocellular carcinoma (HCC) or metastatic carcinoma, with at least one of the tumors being ≤ 1.5 cm in diameter.
Interventions
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Sponsors
University of California, Davis
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with primary hepatocellular carcinoma (HCC) or secondary (metastatic) carcinoma of the liver who have been referred for ultrasound-guided radiofrequency ablation (RFA) treatment * Recent (within 90 days) CT or MRI scan with report of one or more tumors ≤ 1.5 cm in diameter * Patient is stable and is to be managed conservatively (i.e. non-surgically) * 18 years of age or older * Ability and willingness to provide written informed consent
Exclusion criteria
* Known or suspected cardiac shunt(s) * Known sensitivity to octafluoropropane * Pregnant or breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography | 15 min | After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth | 15 min | Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type |
Countries
United States
Participant flow
Recruitment details
Closed to enrollment
Pre-assignment details
Closed to enrollment
Participants by arm
| Arm | Count |
|---|---|
| Contrast Sonography Contrast-enhanced sonography perflutren lipid microspheres : IV in 0.1 cc doses, as needed, to enhance lesion conspicuity | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Contrast Sonography |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Sex/Gender, Customized Female | 3 Participants |
| Sex/Gender, Customized Male | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography
After the systemic iv injection of ultrasound contrast, the real time ultrasound images are visually evaluated, and small intrahepatic tumors are detected on the images. The images pre-contrast and post contrast are compared visually. One tumor per participant was analyzed.
Time frame: 15 min
Population: Tumors were evaluated prior and post contrast injection, 1 tumor per participant
| Arm | Measure | Value (COUNT_OF_UNITS) |
|---|---|---|
| Contrast Sonography | Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography | 8 tumor |
Secondary
Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth
Visual estimation of the the effect of tumor type, size, location and depth on the conspicuity of small tumors on contrast-enhanced sonography using prior assessment or pathology for tumor type
Time frame: 15 min
Population: Tumor types showed differences in enhancement
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Contrast Sonography | Number of Participants With an Increase in Echogenicity (Brightness) of Small Intrahepatic Tumors Following Contrast-enhanced Sonography Based on Tumor Type, Size, Location and Depth | 8 participants |