NCT02764801

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at below P25 for phase_3 hepatocellular-carcinoma

Timeline
Completed

Started Apr 2016

Longer than P75 for phase_3 hepatocellular-carcinoma

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

April 21, 2016

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 6, 2016

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
8 months until next milestone

Results Posted

Study results publicly available

September 21, 2023

Completed
Last Updated

May 6, 2025

Status Verified

May 1, 2025

Enrollment Period

5.7 years

First QC Date

April 21, 2016

Results QC Date

June 28, 2023

Last Update Submit

May 2, 2025

Conditions

Hepatocellular CarcinomaChemoembolization, Therapeutic

Outcome Measures

Primary Outcomes (2)

  • Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization

    The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1-2 weeks post chemoembolization.

    Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure

  • Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment One Month After Initial Chemoembolization

    The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1 month post chemoembolization.

    Percentage of patients correctly identified as requiring re-treatment will be identified 1 month after the subject's chemoembolization procedure

Study Arms (1)

Contrast ultrasound arm

EXPERIMENTAL

Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response.

Drug: Ultrasound contrast agent (Contrast-enhanced ultrasound)Device: Logiq E9 Scanner (Contrast-enhanced ultrasound)

Interventions

Ultrasound contrast agent (Contrast-enhanced ultrasound)DRUG

Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand.

Also known as: Definity (Lantheus Medical Imaging), Microbubble contrast agent
Contrast ultrasound arm
Logiq E9 Scanner (Contrast-enhanced ultrasound)DEVICE

Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.

Also known as: Ultrasound Scanner
Contrast ultrasound arm

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of California, San Diego

La Jolla, California, 92093, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (3)

  • Shaw CM, Eisenbrey JR, Lyshchik A, O'Kane PL, Merton DA, Machado P, Pino L, Brown DB, Forsberg F. Contrast-enhanced ultrasound evaluation of residual blood flow to hepatocellular carcinoma after treatment with transarterial chemoembolization using drug-eluting beads: a prospective study. J Ultrasound Med. 2015 May;34(5):859-67. doi: 10.7863/ultra.34.5.859.

    PMID: 25911704BACKGROUND

  • Kono Y, Lucidarme O, Choi SH, Rose SC, Hassanein TI, Alpert E, Mattrey RF. Contrast-enhanced ultrasound as a predictor of treatment efficacy within 2 weeks after transarterial chemoembolization of hepatocellular carcinoma. J Vasc Interv Radiol. 2007 Jan;18(1 Pt 1):57-65. doi: 10.1016/j.jvir.2006.10.016.

    PMID: 17296705BACKGROUND

  • Savsani E, Shaw CM, Forsberg F, Wessner CE, Lyshchik A, O'Kane P, Liu JB, Balasubramanya R, Roth CG, Naringrekar H, Keith SW, Tan A, Anton K, Bradigan K, Civan J, Schultz S, Shamimi-Noori S, Hunt S, Soulen MC, Mattrey RF, Kono Y, Eisenbrey JR. Contrast-enhanced US Evaluation of Hepatocellular Carcinoma Response to Chemoembolization: A Prospective Multicenter Trial. Radiology. 2023 Oct;309(1):e230727. doi: 10.1148/radiol.230727.

    PMID: 37847138DERIVED

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

perflutren

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Results Point of Contact

Title
John Eisenbrey, PhD
Organization
Thomas Jefferson University
John.Eisenbrey@jefferson.edu
(215) 503-5188

Study Officials

  • John Eisenbrey, PhD

    Thomas Jefferson University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2016

First Posted

May 6, 2016

Study Start

April 1, 2016

Primary Completion

December 1, 2021

Study Completion

February 1, 2023

Last Updated

May 6, 2025

Results First Posted

September 21, 2023

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(3)