Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma

Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 2
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
Sidney Kimmel Cancer Center at Thomas Jefferson University
RECRUITING
Philadelphia
Contact Information
Primary
John Eisenbrey, MD
John.Eisenbrey@jefferson.edu
215-503-5188
Time Frame
Start Date: 2021-12-14
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 20
Treatments
Experimental: Diagnostic (perflutren protein-type A microspheres, CEUS)
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo ultrasound at 1 month before TARE, 1-4 hours, 1 week, and 2 weeks post-TARE.
Related Therapeutic Areas
Sponsors
Collaborators: National Cancer Institute (NCI)
Leads: Thomas Jefferson University

This content was sourced from clinicaltrials.gov