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

  • STATUS
    Recruiting
  • End date
    Oct 31, 2023
  • participants needed
    20
  • sponsor
    Thomas Jefferson University
Updated on 6 May 2022
cancer

Summary

This clinical 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 intrahepatic cholangiocarcinoma (ICC) 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.

Details
Condition Intrahepatic Cholangiocarcinoma
Treatment Contrast-enhanced ultrasound, Perflutren Protein-Type A Microspheres
Clinical Study IdentifierNCT05328167
SponsorThomas Jefferson University
Last Modified on6 May 2022

Eligibility

Yes No Not Sure

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
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