Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Liver Neoplasms Clinical Trial

Official title:

Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00584402
• Other study ID #: 200715241
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 10, 2017
• Start date: April 2007
• Est. completion date: March 2009

Study information

• Verified date: July 2017
• Source: University of California, Davis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: March 2009
• Est. primary completion date: March 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

Drug:
• perflutren lipid microspheres
perflutren lipid microspheres IV in 0.1 cc doses, as needed, to enhance lesion conspicuity

Locations

Country	Name	City	State
United States	UC Davis Medical Center	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	15 min
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	15 min