Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment

Intrahepatic Cholangiocarcinoma Clinical Trial

Official title:

Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328167
• Other study ID #: 21F.1081
• Status: Recruiting
• Phase: Phase 2
• Start date: December 14, 2021
• Est. completion date: October 31, 2024

Study information

• Verified date: January 2024
• Source: Thomas Jefferson University
• Contact: John Eisenbrey, MD
• Phone: 215-503-5188
• Email: John.Eisenbrey[@]jefferson.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This phase II trial tests whether contrast-enhanced ultrasound can predict the response of bile duct cancer to targeted radiotherapy (radioembolization treatment). Contrast-enhanced ultrasound uses gas microbubbles that may provide enhancement on ultrasound. It is also possible to pop these microbubbles using ultrasound imaging. Tumors that experience popping of these microbubbles may be easier to kill with radiotherapies. Therefore, this trial may also help doctors see if ultrasound-triggered microbubble popping can improve bile duct cancer response to radiotherapy. Another purpose of this trial is to test if the pressure inside the tumor estimated through ultrasound can be used to predict the tumor response to radiotherapy.

Description:

PRIMARY OBJECTIVE:

I. To determine the ability of quantitative volumetric contrast-enhanced ultrasound (CEUS) to predict non-hepatocellular carcinoma (HCC) tumor response to transarterial radioembolization (TARE) prior to therapy.

SECONDARY OBJECTIVES:

I. To characterize the safety and preliminary efficacy of using localized ultrasound contrast agent (UCA) inertial cavitation to improve ICC response to radioembolization.

II. To determine if CEUS estimated tumor perfusion and residual vascularity 7-14 days post treatment can predict ICC response to radioembolization.

III. To evaluate tumoral response using the patient's 1 month magnetic resonance imaging (MRI) (obtained clinically) and determine the accuracy of MR or computed tomography (CT) tumor evaluation at this earlier time point.

EXPLORATORY OBJECTIVE:

I. To examine the utility of subharmonic aided pressure estimation (SHAPE) to noninvasively monitor tumoral interstitial fluid pressure (IFP) and provide an early biomarker of radiotherapy response.

OUTLINE:

Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo ultrasound at 1 month before TARE, 1-4 hours, 1 week, and 2 weeks post-TARE.

After completion of study, patients are followed for 1 year.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be scheduled for sub-lobar radioembolization therapy of a previously untreated intrahepatic cholangiocarcinoma greater than 1 cm but small enough to be fully visualized in the ultrasound three-dimensional (3D) volume (approximately 6 cm maximum diameter, but depth dependent)

• Be at least 18 years of age

• Be medically stable

• If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam

• Have signed Informed Consent to participate in the study

Exclusion Criteria:

• Females who are pregnant or nursing

• Patients with recent cerebral hemorrhage

• Patients with known sensitivities to albumin, blood, or blood products

• Patients with known hypersensitivity to perflutren

• Patients with known congenital heart defects

• Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli

• Patients with bilirubin levels > 2 mg/dL

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Intrahepatic Cholangiocarcinoma

Intervention

Drug:
• Perflutren Protein-Type A Microspheres
Given IV

Procedure:
• Contrast-Enhanced Ultrasound
Undergo CEUS

Locations

Country	Name	City	State
United States	Sidney Kimmel Cancer Center at Thomas Jefferson University	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor complete response (CR) and partial response (PR)	Testing for the effect of radioembolization on tumor response will be conducted using non-parametric Mann-Whitney U-tests of the differences in Response Evaluation Criteria in Solid Tumors (mRECIST) distributions between historical controls and enrolled patients.	Up to 6 months post-transarterial radioembolization (TARE)