Contrast-enhanced Ultrasound Evaluation of Chemoembolization

• Status: Recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this trial is to evaluate the sensitivity and specificity of 2D and 4D contrast enhanced ultrasound for monitoring transarterial chemoembolization (TACE) response 1-2 weeks and 1 month post treatment as an alternative to contrast-enhanced magnetic resonance (MRI) or computed tomography (CT) imaging

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University; Thomas Jefferson University
• Collaborators: GE Healthcare; Lantheus Medical Imaging; National Institutes of Health (NIH); University of California, San Diego; Vanderbilt University; Vanderbilt University Medical Center

Criteria

Inclusion Criteria:

• Patients >= 21 years of age

• Patient capable of making informed decisions regarding his/her treatment

• Scheduled for TACE treatment of a HCC mass (lesions reported as Liver Imaging Reporting and Data Systems 4B or 5 or Organ Procurement and Transplantation Network 5a or 5b)

• Negative pregnancy test in a female of child-bearing age.

• Have an HCC mass viewable on grayscale B-mode ultrasound.

Exclusion Criteria:

• Females who are pregnant or nursing.

• Patients not eligible or scheduled for TACE of a HCC mass.

• Patients who have received an investigational drug in the 30 days before study drug administration, or will receive one within 72 h after their final CEUS exam.

• Patients who have received prior radioembolization (Y90) of the lesion of interest.

• Patients with known or suspected cardiac shunts.

• Patients with pulmonary hypertension or unstable cardiopulmonary conditions.

• Patients who are medically unstable, patients who are seriously or terminally ill, and patients whose clinical course is unpredictable. For example:

• Patients with unstable occlusive disease (e.g., crescendo angina)

• Patients with clinically unstable cardiac arrhythmias

• Patients with uncontrolled congestive heart failure (NYHA Class IV)