Trial Outcomes & Findings for Contrast-enhanced Ultrasound Evaluation of Chemoembolization (NCT NCT02764801)

NCT ID: NCT02764801

Last Updated: 2025-05-06

Results Overview

The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1-2 weeks post chemoembolization.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 131 participants
• Primary outcome timeframe: Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure
• Results posted on: 2025-05-06

Participant Flow

Participant milestones

Measure	Contrast Ultrasound Arm Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Overall Study STARTED	131
Overall Study COMPLETED	103
Overall Study NOT COMPLETED	28

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Contrast-enhanced Ultrasound Evaluation of Chemoembolization

Baseline characteristics by cohort

Measure	Contrast Ultrasound Arm n=131 Participants Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	131 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	106 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	110 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	13 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	19 Participants n=5 Participants
Race (NIH/OMB) White	78 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=5 Participants
Region of Enrollment United States	131 participants n=5 Participants

PRIMARY outcome

Timeframe: Percentage of patients correctly identified as requiring re-treatment will be identified 1-2 weeks after the subject's chemoembolization procedure

The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1-2 weeks post chemoembolization.

Outcome measures

Measure

Contrast Ultrasound Arm n=103 Participants Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.

Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment Two Weeks After Initial Chemoembolization

94 percentage Interval 88.0 to 97.0

PRIMARY outcome

Timeframe: Percentage of patients correctly identified as requiring re-treatment will be identified 1 month after the subject's chemoembolization procedure

The ability of contrast-enhanced ultrasound to detect residual disease (and thereby need for tumor re-treatment) will be determined 1 month post chemoembolization.

Outcome measures

Measure

Contrast Ultrasound Arm n=103 Participants Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.

Percentage of Patients Correctly Identified as Requiring Tumor Re-treatment One Month After Initial Chemoembolization

91 percentage Interval 84.0 to 95.0

Adverse Events

Contrast Ultrasound Arm

Serious events: 4 serious events

Other events: 4 other events

Deaths: 35 deaths

Serious adverse events

Measure	Contrast Ultrasound Arm n=103 participants at risk Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Respiratory, thoracic and mediastinal disorders shortness of breath	0.97% 1/103 • Number of events 1 • 5 years Unlikely patients will die from imaging study
Cardiac disorders episodic atrial fibrillation	0.97% 1/103 • Number of events 1 • 5 years Unlikely patients will die from imaging study
Respiratory, thoracic and mediastinal disorders esophageal variceal bleeding	0.97% 1/103 • Number of events 1 • 5 years Unlikely patients will die from imaging study
Respiratory, thoracic and mediastinal disorders late dyspnea	0.97% 1/103 • Number of events 1 • 5 years Unlikely patients will die from imaging study

Other adverse events

Measure	Contrast Ultrasound Arm n=103 participants at risk Patients receiving contrast-enhanced ultrasound for diagnosis of chemoembolization response. Ultrasound contrast agent (Contrast-enhanced ultrasound): Intravenous injection of ultrasound contrast agent followed by saline flush though an angiocatheter in the arm or hand. Logiq E9 Scanner (Contrast-enhanced ultrasound): Ultrasound scanning using a commercial scanner with a C1-5-D broad-spectrum convex transducer followed by a RAB2-5-D broad-spectrum real-time 4D transducer.
Gastrointestinal disorders nausea/vomiting	0.97% 1/103 • Number of events 103 • 5 years Unlikely patients will die from imaging study
Product Issues IV infiltration	0.97% 1/103 • Number of events 103 • 5 years Unlikely patients will die from imaging study
General disorders post-embolization syndrome	1.9% 2/103 • Number of events 103 • 5 years Unlikely patients will die from imaging study

Additional Information

John Eisenbrey, PhD

Thomas Jefferson University

Phone: (215) 503-5188

Email: John.Eisenbrey@jefferson.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place