Trial Outcomes & Findings for Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer (NCT NCT03199274)
NCT ID: NCT03199274
Last Updated: 2026-01-02
Results Overview
Measured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction \[UTMD\] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis. Tumor response assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST). The mRECIST scale includes four ordered categories: * Complete Response (best outcome) * Partial Response * Stable Disease * Progressive Disease (worst outcome)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
104 participants
Primary outcome timeframe
Up to 4 months
Results posted on
2026-01-02
Participant Flow
Participant milestones
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
|---|---|---|
|
Overall Study
STARTED
|
52
|
52
|
|
Overall Study
COMPLETED
|
48
|
50
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Deemed screen fail because he had no arteries to access during flow study
|
0
|
1
|
Baseline Characteristics
Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
Baseline characteristics by cohort
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
n=52 Participants
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
n=52 Participants
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
Total
n=104 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=9 Participants
|
14 Participants
n=6 Participants
|
30 Participants
n=9 Participants
|
|
Age, Categorical
>=65 years
|
36 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
74 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=9 Participants
|
8 Participants
n=6 Participants
|
28 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=9 Participants
|
44 Participants
n=6 Participants
|
76 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
50 Participants
n=9 Participants
|
50 Participants
n=6 Participants
|
100 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=9 Participants
|
7 Participants
n=6 Participants
|
15 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=9 Participants
|
38 Participants
n=6 Participants
|
75 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 4 monthsMeasured using the modified Response Evaluation Criteria in Solid Tumors. Will be tested with a non-parametric Mann- Whitney U-test of the difference in response distributions between control (radioembolization alone) and experimental group (ultrasound-triggered microbubble destruction \[UTMD\] + radioembolization). The outcome variable in this analysis, the modified Response Evaluation Criteria in Solid Tumors (mRECIST) score, is treated as an ordinal variable in this analysis. Tumor response assessed using modified Response Evaluation Criteria in Solid Tumors (mRECIST). The mRECIST scale includes four ordered categories: * Complete Response (best outcome) * Partial Response * Stable Disease * Progressive Disease (worst outcome)
Outcome measures
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
n=48 Participants
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
n=50 Participants
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
|---|---|---|
|
Treatment Response to Yttrium Y-90 Radioembolization
Stable Disease
|
2 Participants
|
17 Participants
|
|
Treatment Response to Yttrium Y-90 Radioembolization
Partial Response
|
17 Participants
|
17 Participants
|
|
Treatment Response to Yttrium Y-90 Radioembolization
Complete Response
|
25 Participants
|
13 Participants
|
|
Treatment Response to Yttrium Y-90 Radioembolization
Progressive Disease
|
4 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 14 daysPopulation: Contrast-enhanced ultrasound (study intervention) is only collected from patients in Arm 1.
Perfusion will be characterized in terms of contrast replenishment time intensity curves fit with a 2-parameter exponential recovery curve. The relationship between the normalized perfusion values from this image processing and the patients' subsequent mRECIST scores in the UTMD + radioembolization group will be evaluated with Spearman's rank order correlation. Tumor perfusion measured as fractional vascularity (%) using contrast-enhanced ultrasound (CEUS). Values range from 0% (no perfusion) to 100% (maximal perfusion).
Outcome measures
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
n=48 Participants
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
|---|---|---|
|
Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses
Viable Tumors
|
62 percentage of tumor vascularity
Standard Deviation 28
|
—
|
|
Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses
Non-Viable Tumors
|
38 percentage of tumor vascularity
Standard Deviation 24
|
—
|
Adverse Events
Group I (Perflutren Protein-type A Microspheres, CEUS)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group II (Standard of Care)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group I (Perflutren Protein-type A Microspheres, CEUS)
n=52 participants at risk
Patients receive perflutren protein-type A microspheres IV over 10 minutes and undergo CEUS over 60 minutes at 1-6 hours and at approximately 7 and 14 days after yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
Perflutren Protein-Type A Microspheres: Given IV.
Dynamic Contrast-Enhanced Ultrasound Imaging: Undergo CEUS
|
Group II (Standard of Care)
n=52 participants at risk
Patients undergo standard of care yttrium Y-90 radioembolization.
Yttrium-90 Microsphere Radioembolization: Undergo standard of care Y-90 radioembolization
|
|---|---|---|
|
General disorders
Fever
|
7.7%
4/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
Skin and subcutaneous tissue disorders
Hives/rash
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
General disorders
Fatigue
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
Gastrointestinal disorders
Nausea
|
3.8%
2/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
3.8%
2/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
Nervous system disorders
Possible Seizure
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
General disorders
Dyspnea
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
General disorders
Shoulder Pain
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
|
General disorders
Shortness of Breath
|
1.9%
1/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
0.00%
0/52 • From enrollment through 3-4 months post-treatment
Adverse events were assessed through participant reports, systematic review of medical records, and clinical monitoring at 1 month and 3-4 month follow up visits
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place