Trial Outcomes & Findings for Contrast-Enhanced Ultrasound for the Prediction of Bile Duct Cancer Response to Radioembolization Treatment (NCT NCT05328167)

Last Updated: 2025-10-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

assessed at 3 to 6 months post-TARE

Results posted on

2025-10-28

Participant Flow

Participant milestones

Participant milestones
Measure	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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Overall Study STARTED	16
Overall Study COMPLETED	14
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Overall Study Treatment cancelled prior to radioembolization	1
Overall Study imaging not obtained for primary outcome assessment	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Diagnostic (perflutren protein-type A microspheres, CEUS) n=16 Participants 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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	5 Participants n=5 Participants
Race (NIH/OMB) White	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: assessed at 3 to 6 months post-TARE

Outcome measures

Outcome measures
Measure	Diagnostic (perflutren protein-type A microspheres, CEUS) n=14 Participants 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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Number of Participants With Tumor Complete Response (CR)	7 Participants

PRIMARY outcome

Timeframe: assessed at 3 to 6 months post-TARE

Outcome measures

Outcome measures
Measure	Diagnostic (perflutren protein-type A microspheres, CEUS) n=14 Participants 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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Number of Participants With Tumor Partial Response (PR)	3 Participants

PRIMARY outcome

Timeframe: assessed at 3 to 6 months post-TARE

Outcome measures

Outcome measures
Measure	Diagnostic (perflutren protein-type A microspheres, CEUS) n=14 Participants 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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Number of Participants With Stable Disease	4 Participants

PRIMARY outcome

Timeframe: assessed at 3 to 6 months post-TARE

Outcome measures

Outcome measures
Measure	Diagnostic (perflutren protein-type A microspheres, CEUS) n=14 Participants 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. Perflutren Protein-Type A Microspheres: Given IV Contrast-Enhanced Ultrasound: Undergo CEUS
Number of Participants With Progressive Disease	0 Participants

Adverse Events

Diagnostic (perflutren protein-type A microspheres, CEUS)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. John Eisenbrey, Associate Professor

Thomas Jefferson University

Phone: 215-503-5188

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place