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

Sponsor
Thomas Jefferson University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05328167
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
22.5
Anticipated Duration (Months)
0.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This clinical 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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Perflutren Protein-Type A Microspheres
  • Procedure: Contrast-Enhanced Ultrasound
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. To determine the ability of quantitative volumetric contrast-enhanced ultrasound (CEUS) to predict intrahepatic cholangiocarcinoma (ICC) response to transarterial radioembolization (TARE) prior to therapy.
SECONDARY OBJECTIVES:

  1. To characterize the safety and preliminary efficacy of using localized ultrasound contrast agent (UCA) inertial cavitation to improve ICC response to radioembolization.

  2. To determine if CEUS estimated tumor perfusion and residual vascularity 7-14 days post treatment can predict ICC response to radioembolization.

  3. To evaluate tumoral response using the patient's 1 month magnetic resonance imaging (MRI) (obtained clinically) and determine the accuracy of MR or computed tomography (CT) tumor evaluation at this earlier time point.

EXPLORATORY OBJECTIVE:
  1. To examine the utility of subharmonic aided pressure estimation (SHAPE) to noninvasively monitor tumoral interstitial fluid pressure (IFP) and provide an early biomarker of radiotherapy response.
OUTLINE:

Patients receive perflutren protein-type A microspheres intravenously (IV) over 10 minutes and undergo ultrasound at 1 month before TARE, 1-4 hours, 1 week, and 2 weeks post-TARE.

After completion of study, patients are followed for 1 year.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma
Actual Study Start Date :
Dec 14, 2021
Anticipated Primary Completion Date :
Oct 31, 2023
Anticipated Study Completion Date :
Oct 31, 2023

Arms and Interventions

Arm Intervention/Treatment
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.

Drug: Perflutren Protein-Type A Microspheres
Given IV
Other Names:
  • Optison

    • Procedure: Contrast-Enhanced Ultrasound
    Undergo CEUS
    Other Names:
  • CEUS

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Tumor complete response (CR) and partial response (PR) [Up to 6 months post-transarterial radioembolization (TARE)]

      Testing for the effect of radioembolization on tumor response will be conducted using non-parametric Mann-Whitney U-tests of the differences in Response Evaluation Criteria in Solid Tumors (mRECIST) distributions between historical controls and enrolled patients.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sidney Kimmel Cancer Center at Thomas Jefferson University Philadelphia Pennsylvania United States 19107

    Sponsors and Collaborators

    • Thomas Jefferson University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Thomas Jefferson University
    ClinicalTrials.gov Identifier:
    NCT05328167
    Other Study ID Numbers:
    • 21F.1081
    First Posted:
    Apr 14, 2022
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Cholangiocarcinoma

    Study Results

    No Results Posted as of Apr 14, 2022