COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma

Quick Facts

Study Start:2021-12-14
Study Completion:2025-08-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05328167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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)
  2. * Be at least 18 years of age
  3. * Be medically stable
  4. * If a female of child-bearing age, have a negative pregnancy test prior to each ultrasound exam
  5. * Have signed Informed Consent to participate in the study
  1. * Females who are pregnant or nursing
  2. * Patients with recent cerebral hemorrhage
  3. * Patients with known sensitivities to albumin, blood, or blood products
  4. * Patients with known hypersensitivity to perflutren
  5. * Patients with known congenital heart defects
  6. * Patients with severe emphysema, pulmonary vasculitis, or a history of pulmonary emboli
  7. * Patients with bilirubin levels \> 2 mg/dL

Contacts and Locations

Study Locations (Sites)

Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
United States

Collaborators and Investigators

Sponsor: Thomas Jefferson University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-12-14
Study Completion Date2025-08-31

Study Record Updates

Study Start Date2021-12-14
Study Completion Date2025-08-31

Terms related to this study

Additional Relevant MeSH Terms

  • Intrahepatic Cholangiocarcinoma