Ignite Creation Date:
2025-12-25 @ 12:38 AM
Ignite Modification Date:
2025-12-25 @ 10:48 PM
Study NCT ID:
NCT05328167
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2022-04-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment
Sponsor:
Thomas Jefferson University
Organization:
Study Overview
Official Title:
Contrast-Enhanced Ultrasound for Diagnosis and Therapy of Cholangiocarcinoma
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
Detailed Description:
PRIMARY OBJECTIVE:
I. To determine the ability of quantitative volumetric contrast-enhanced ultrasound (CEUS) to predict non-hepatocellular carcinoma (HCC) tumor 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.
I. To determine the ability of quantitative volumetric contrast-enhanced ultrasound (CEUS) to predict non-hepatocellular carcinoma (HCC) tumor 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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JT 19280 | OTHER | JeffTrial Number | View | |
| R21CA259750 | NIH | None | https://reporter.nih.gov/quic… | View |