Status:

COMPLETED

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

Lead Sponsor:

Thomas Jefferson University

Collaborating Sponsors:

National Cancer Institute (NCI)

Conditions:

Intrahepatic Cholangiocarcinoma

Eligibility:

All Genders

18+ years

Phase:

PHASE2

Brief 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 ga...

Detailed 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 radioemboli...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

December 14 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

August 31 2025

Estimated Enrollment :

16 Patients enrolled

Trial Details

Trial ID

NCT05328167

Start Date

December 14 2021

End Date

August 31 2025

Last Update

October 28 2025

Active Locations (1)

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1

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, United States, 19107