Trial · NCT03199274

Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer

NCT03199274, Phase 2, Completed, Thomas Jefferson University; results first posted 2025-08-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer. Trials, record NCT03199274. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03199274

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer
NCT number: NCT03199274
Status: Completed
Phases: Phase 2
Enrollment: 104 participants, actual
Lead sponsor: Thomas Jefferson University
Conditions: Hepatocellular Carcinoma
Interventions: Yttrium-90 Microsphere Radioembolization, Perflutren Protein-Type A Microspheres, Dynamic Contrast-Enhanced Ultrasound Imaging
First posted: 2017-06-26
Last updated: 2026-01-02
Results first posted: 2025-08-20

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Treatment Response to Yttrium Y-90 Radioembolization	Up to 4 months	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)
Primary	Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses	Up to 14 days	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).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Treatment Response to Yttrium Y-90 Radioembolization	Up to 4 months		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses	Up to 14 days	Contrast-enhanced ultrasound (study intervention) is only collected from patients in Arm 1.	percentage of tumor vascularity	MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Treatment Response to Yttrium Y-90 Radioembolization	Group I (Perflutren Protein-type A Microspheres, CEUS)	Stable Disease	2		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group II (Standard of Care)	Stable Disease	17		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group I (Perflutren Protein-type A Microspheres, CEUS)	Partial Response	17		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group II (Standard of Care)	Partial Response	17		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group I (Perflutren Protein-type A Microspheres, CEUS)	Complete Response	25		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group II (Standard of Care)	Complete Response	13		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group I (Perflutren Protein-type A Microspheres, CEUS)	Progressive Disease	4		Participants
Treatment Response to Yttrium Y-90 Radioembolization	Group II (Standard of Care)	Progressive Disease	3		Participants
Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses	Group I (Perflutren Protein-type A Microspheres, CEUS)	Viable Tumors	62	Standard Deviation 28	percentage of tumor vascularity
Tumor Perfusion Measured by Contrast-enhanced Ultrasound Between Ultrasound-triggered Microbubble Destruction Pulses	Group I (Perflutren Protein-type A Microspheres, CEUS)	Non-Viable Tumors	38	Standard Deviation 24	percentage of tumor vascularity

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Group I (Perflutren Protein-type A Microspheres, CEUS)	52
Overall Study	STARTED	Group II (Standard of Care)	52
Overall Study	COMPLETED	Group I (Perflutren Protein-type A Microspheres, CEUS)	48
Overall Study	COMPLETED	Group II (Standard of Care)	50
Overall Study	NOT COMPLETED	Group I (Perflutren Protein-type A Microspheres, CEUS)	4
Overall Study	NOT COMPLETED	Group II (Standard of Care)	2

Source ClinicalTrials.gov

Adverse events18

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Fever	General disorders	Group I (Perflutren Protein-type A Microspheres, CEUS)	4	52
other	Fever	General disorders	Group II (Standard of Care)	0	52
other	Hives/rash	Skin and subcutaneous tissue disorders	Group I (Perflutren Protein-type A Microspheres, CEUS)	1	52
other	Hives/rash	Skin and subcutaneous tissue disorders	Group II (Standard of Care)	0	52
other	Fatigue	General disorders	Group I (Perflutren Protein-type A Microspheres, CEUS)	1	52
other	Fatigue	General disorders	Group II (Standard of Care)	0	52
other	Nausea	Gastrointestinal disorders	Group I (Perflutren Protein-type A Microspheres, CEUS)	2	52
other	Nausea	Gastrointestinal disorders	Group II (Standard of Care)	2	52
other	Possible Seizure	Nervous system disorders	Group I (Perflutren Protein-type A Microspheres, CEUS)	0	52
other	Possible Seizure	Nervous system disorders	Group II (Standard of Care)	1	52

1 to 10 of 18Source ClinicalTrials.gov

See all 18 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Group I (Perflutren Protein-type A Microspheres, CEUS)	0	52
Total, all-cause mortality	Group II (Standard of Care)	0	52
Total, other adverse events	Group I (Perflutren Protein-type A Microspheres, CEUS)	4	52
Total, other adverse events	Group II (Standard of Care)	2	52
Total, serious adverse events	Group I (Perflutren Protein-type A Microspheres, CEUS)	0	52
Total, serious adverse events	Group II (Standard of Care)	0	52

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
41025990	DERIVED

Source PubMed

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
R01CA238241	Microbubble Cavitation for Improving Hepatocellular Carcinoma Radioembolization	EISENBREY, JOHN; ANTON, KEVIN	THOMAS JEFFERSON UNIVERSITY	NATIONAL CANCER INSTITUTE	2020 to 2024

Source NIH RePORTER

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Group I (Perflutren Protein-type A Microspheres, CEUS) vs Group II (Standard of Care): deaths from any cause	Trial comparisons
Group I (Perflutren Protein-type A Microspheres, CEUS) vs Group II (Standard of Care): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03199274

GET https://conductscience.org/api/trials/v1/NCT03199274/registered

API reference For AI assistants