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Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation
This study has been completed.
Sponsor:
University of California, Davis
Information provided by (Responsible Party):
University of California, Davis
ClinicalTrials.gov Identifier:
NCT00584402
First received: December 21, 2007
Last updated: July 10, 2017
Last verified: July 2017
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Purpose
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 | Intervention |
|---|---|
| Liver Neoplasms | Drug: perflutren lipid microspheres |
| Study Type: | Interventional |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by University of California, Davis:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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
| Enrollment: | 8 |
| Study Start Date: | April 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Contrast sonography
Contrast-enhanced sonography perflutren lipid microspheres
|
Drug: perflutren lipid microspheres
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity
Other Name: Definity
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584402
Please refer to this study by its ClinicalTrials.gov identifier: NCT00584402
Locations
| United States, California | |
| UC Davis Medical Center | |
| Sacramento, California, United States, 95817 | |
Sponsors and Collaborators
University of California, Davis
Investigators
| Principal Investigator: | John P. McGahan, M.D. | UC Davis School of Medicine Dept. of Radiology |
More Information
| Responsible Party: | University of California, Davis |
| ClinicalTrials.gov Identifier: | NCT00584402 History of Changes |
| Other Study ID Numbers: |
200715241 |
| Study First Received: | December 21, 2007 |
| Results First Received: | July 3, 2013 |
| Last Updated: | July 10, 2017 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Keywords provided by University of California, Davis:
|
liver cancer |
Additional relevant MeSH terms:
|
Liver Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |
ClinicalTrials.gov processed this record on September 21, 2017