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Search / Trial NCT05328167

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

Launched by THOMAS JEFFERSON UNIVERSITY · Apr 7, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether a special type of ultrasound called contrast-enhanced ultrasound can help doctors predict how well a targeted radiotherapy treatment, known as radioembolization, will work for patients with bile duct cancer, specifically intrahepatic cholangiocarcinoma. During this ultrasound, tiny gas bubbles are used to improve the images of the tumor. The study will see if these bubbles can be made to pop using the ultrasound, which might make the cancer cells easier to treat with radiation. The trial will also explore if measuring the pressure inside the tumor with ultrasound can give clues about how well the treatment will work.

To participate in this trial, you need to be at least 18 years old and scheduled to receive radioembolization therapy for a bile duct tumor that is more than 1 cm but less than 6 cm in size. You should also be in good health and able to give consent to join the study. However, there are some conditions that would prevent participation, such as being pregnant, having certain heart or lung issues, or a high level of a substance called bilirubin in your blood. If you choose to participate, you can expect to undergo several ultrasound exams to help gather the necessary information for the study.

Gender

ALL

Eligibility criteria

  • 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

About Thomas Jefferson University

Thomas Jefferson University is a distinguished academic institution located in Philadelphia, Pennsylvania, renowned for its commitment to advancing healthcare through research and education. As a clinical trial sponsor, the university leverages its extensive resources and interdisciplinary expertise to conduct innovative research aimed at improving patient outcomes. With a focus on translational medicine, Thomas Jefferson University collaborates with various stakeholders, including healthcare professionals, industry partners, and regulatory agencies, to ensure the highest standards of scientific rigor and ethical conduct in its clinical trials. The institution is dedicated to fostering a culture of excellence in research, ultimately contributing to the advancement of medical knowledge and the development of novel therapeutic interventions.

Locations

Philadelphia, Pennsylvania, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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