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

NCT05328167 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: 21F.1081JT 19280R21CA259750
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Intrahepatic Cholangiocarcinoma

Outcome Measures

Primary Outcomes (4)

• Number of Participants With Tumor Complete Response (CR)

  Assessed by modified RECIST (mRECIST) criteria using contrast-enhanced CT or MRI reviewed by two independent readers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), indicated by a significant increase (at least 20%) in target lesions or the appearance of new target lesions; Stable Disease (SD) means neither the criteria for PR nor for Progressive Disease (PD) have been met.

  assessed at 3 to 6 months post-TARE

• Number of Participants With Tumor Partial Response (PR)

  Assessed by modified RECIST (mRECIST) criteria using contrast-enhanced CT or MRI reviewed by two independent readers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), indicated by a significant increase (at least 20%) in target lesions or the appearance of new target lesions; Stable Disease (SD) means neither the criteria for PR nor for Progressive Disease (PD) have been met.

  assessed at 3 to 6 months post-TARE

• Number of Participants With Stable Disease

  Assessed by modified RECIST (mRECIST) criteria using contrast-enhanced CT or MRI reviewed by two independent readers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), indicated by a significant increase (at least 20%) in target lesions or the appearance of new target lesions; Stable Disease (SD) means neither the criteria for PR nor for Progressive Disease (PD) have been met.

  assessed at 3 to 6 months post-TARE

• Number of Participants With Progressive Disease

  Assessed by modified RECIST (mRECIST) criteria using contrast-enhanced CT or MRI reviewed by two independent readers. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease (PD), indicated by a significant increase (at least 20%) in target lesions or the appearance of new target lesions; Stable Disease (SD) means neither the criteria for PR nor for Progressive Disease (PD) have been met.

  assessed at 3 to 6 months post-TARE

Study Arms (1)

Diagnostic (perflutren protein-type A microspheres, CEUS)

EXPERIMENTAL

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.

Drug: Perflutren Protein-Type A Microspheres; Procedure: Contrast-Enhanced Ultrasound

Interventions

Perflutren Protein-Type A Microspheres DRUG

Given IV

Also known as: Optison

Diagnostic (perflutren protein-type A microspheres, CEUS)

Contrast-Enhanced Ultrasound PROCEDURE

Undergo CEUS

Also known as: CEUS

Diagnostic (perflutren protein-type A microspheres, CEUS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Thomas Jefferson University: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Sidney Kimmel Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

FS 069

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Results Point of Contact

• Title: Dr. John Eisenbrey, Associate Professor
• Organization: Thomas Jefferson University

john.eisenbrey@jefferson.edu

215-503-5188

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 14, 2022
• Study Start: December 14, 2021
• Primary Completion: July 31, 2025
• Study Completion: August 31, 2025
• Last Updated: October 28, 2025
• Results First Posted: October 28, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)