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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
16
Given IV
Undergo CEUS
Sidney Kimmel Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: assessed at 3 to 6 months post-TARE
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.