Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
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ClinicalTrials.gov Identifier: NCT00584402 |
Recruitment Status :
Completed
First Posted : January 2, 2008
Results First Posted : July 11, 2017
Last Update Posted : July 11, 2017
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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
Condition or disease | Intervention/treatment | Phase |
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Liver Neoplasms | Drug: perflutren lipid microspheres | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 8 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation |
Study Start Date : | April 2007 |
Actual Primary Completion Date : | March 2009 |
Actual Study Completion Date : | March 2009 |

Arm | Intervention/treatment |
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Experimental: Contrast sonography
Contrast-enhanced sonography perflutren lipid microspheres
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Drug: perflutren lipid microspheres
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Other Name: Definity |
- Percent of Tumors With Increased Echogenicity (Brightness) Following Contrast-enhanced Sonography [ Time Frame: 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.
- 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 [ Time Frame: 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

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00584402
United States, California | |
UC Davis Medical Center | |
Sacramento, California, United States, 95817 |
Principal Investigator: | John P. McGahan, M.D. | UC Davis School of Medicine Dept. of Radiology |
Responsible Party: | University of California, Davis |
ClinicalTrials.gov Identifier: | NCT00584402 |
Other Study ID Numbers: |
200715241 |
First Posted: | January 2, 2008 Key Record Dates |
Results First Posted: | July 11, 2017 |
Last Update Posted: | July 11, 2017 |
Last Verified: | July 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
liver cancer |
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |