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

Completed · Phase 2

Conditions studied: Intrahepatic Cholangiocarcinoma

In brief

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.

Key facts

Study ID

NCT05328167

Run by

Thomas Jefferson University

People needed

16

Starts

2021-12-14

Expected to finish

2025-08-31

Last updated by the study team

2025-10-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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