Contrast Sonography for Evaluation of Liver Tumors Prior to Radiofrequency Ablation

NCT00584402 | Completed Results

• 1 other identifier: 200715241
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Conditions

Liver Neoplasms

Keywords

liver cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

Contrast sonography

EXPERIMENTAL

Contrast-enhanced sonography perflutren lipid microspheres

Drug: perflutren lipid microspheres

Interventions

perflutren lipid microspheres DRUG

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

Also known as: Definity

Contrast sonography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• years of age or older
• Ability and willingness to provide written informed consent

You may not qualify if:

• Known or suspected cardiac shunt(s)
• Known sensitivity to octafluoropropane
• Pregnant or breastfeeding

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Results Point of Contact

• Title: John McGahan, M.D.
• Organization: University of Califonia, Davis

john.mcgahan@ucdmc.ucdavis.edu

(916)734-0519

Study Officials

• John P. McGahan, M.D.

  UC Davis School of Medicine Dept. of Radiology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 2, 2008
• Study Start: April 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: March 1, 2009
• Last Updated: July 11, 2017
• Results First Posted: July 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)