Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment
Primary Purpose
Intrahepatic Cholangiocarcinoma
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Perflutren Protein-Type A Microspheres
Contrast-Enhanced Ultrasound
Sponsored by
About this trial
This is an interventional diagnostic trial for Intrahepatic Cholangiocarcinoma
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
Sites / Locations
- Sidney Kimmel Cancer Center at Thomas Jefferson UniversityRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (perflutren protein-type A microspheres, CEUS)
Arm Description
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.
Outcomes
Primary Outcome Measures
Tumor complete response (CR) and partial response (PR)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05328167
First Posted
April 7, 2022
Last Updated
June 2, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT05328167
Brief Title
Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment
Official Title
Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2021 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
October 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
Detailed Description
PRIMARY OBJECTIVE:
I. 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:
I. To characterize the safety and preliminary efficacy of using localized ultrasound contrast agent (UCA) inertial cavitation to improve ICC response to radioembolization.
II. To determine if CEUS estimated tumor perfusion and residual vascularity 7-14 days post treatment can predict ICC response to radioembolization.
III. 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:
I. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrahepatic Cholangiocarcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (perflutren protein-type A microspheres, CEUS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Perflutren Protein-Type A Microspheres
Other Intervention Name(s)
Optison
Intervention Description
Given IV
Intervention Type
Procedure
Intervention Name(s)
Contrast-Enhanced Ultrasound
Other Intervention Name(s)
CEUS
Intervention Description
Undergo CEUS
Primary Outcome Measure Information:
Title
Tumor complete response (CR) and partial response (PR)
Description
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.
Time Frame
Up to 6 months post-transarterial radioembolization (TARE)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
John Eisenbrey, MD
Phone
215-503-5188
Email
John.Eisenbrey@jefferson.edu
Facility Information:
Facility Name
Sidney Kimmel Cancer Center at Thomas Jefferson University
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Eisenbrey, MD
Phone
215-503-5188
Email
john.eisenbrey@jefferson.edu
12. IPD Sharing Statement
Learn more about this trial
Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment
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