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Contrast-Enhanced Ultrasound + Radioembolization for Liver Cancer

Q: Has Yttrium-90 Microsphere Radioembolization been sanctioned for use by the FDA?

Although there is some evidence of Yttrium-90 Microsphere Radioembolization's safety, no efficacy studies have been conducted and thus it has received a score of 2.

Q: How many participants have been recruited for this study thus far?

Affirmative. Clinicaltrials.gov contains information that attests to this clinical trial's recruitment process, which began on July 1st 2017 and was last modified on November 16th 2022. The study requires 104 participants from a single site for completion.

Q: Are there any prior instances of Yttrium-90 Microsphere Radioembolization trials being conducted?

Currently, 19 clinical trials for Yttrium-90 Microsphere Radioembolization are underway with 1 trial in Phase 3. These studies can be found at 26 different medical sites across the country; most of which are located within Philadelphia, <a href="https://www.withpower.com/clinical-trials/pennsylvania">Pennsylvania</a>.

Q: For which medical conditions is Yttrium-90 Microsphere Radioembolization commonly prescribed?

Yttrium-90 Microsphere Radioembolization is a common form of treatment for echocardiography and delineation of left ventricular endocardial borders, as well as other <a href="https://www.withpower.com/clinical-trials/cardiovascular">cardiovascular</a> conditions.

Q: Are there opportunities for individuals to enroll in this experimental endeavor?

Yes, the details published on clinicaltrials.gov indicate that recruitment for this trial is still open. It was first posted in July 2017 and last revised on November 16th 2022. The investigators are aiming to enroll 104 patients at a single site.

Phase 2

Waitlist Available

Led By John Eisenbrey, PhD

Research Sponsored by Thomas Jefferson University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be scheduled for sub-lobar radioembolization therapy of a previously untreated HCC mass < 6 cm visible on grayscale ultrasound

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

Study Summary

This trial uses ultrasound contrast agents to improve response to radioembolization therapy in patients with liver cancer.

Who is the study for?

This trial is for stable adults with untreated liver cancer (HCC) masses under 6 cm, visible on ultrasound. They must consent to the study and women of childbearing age need a negative pregnancy test before each exam. It's not for critically ill patients, those with high bilirubin levels or heart failure, pregnant/nursing women, or anyone allergic to perflutren.Check my eligibility

What is being tested?

The trial tests if using Perflutren Protein-Type A Microspheres with contrast-enhanced ultrasound can improve the effectiveness of Yttrium-90 radioembolization therapy in treating liver cancer by making tumors more sensitive to radiation.See study design

What are the potential side effects?

Potential side effects may include allergic reactions to perflutren microspheres such as shortness of breath or skin rashes. The procedure could also cause discomfort at the injection site and has risks associated with exposure to radiation from the therapy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for a specific liver cancer treatment for a tumor smaller than 6 cm.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Treatment response to yttrium Y-90 radioembolization

Tumor perfusion measured by contrast-enhanced ultrasound between ultrasound-triggered microbubble destruction pulses

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group I (perflutren protein-type A microspheres, CEUS)Experimental Treatment3 Interventions

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.

Group II: Group II (standard of care)Active Control1 Intervention

Patients undergo standard of care yttrium Y-90 radioembolization.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dynamic Contrast-Enhanced Ultrasound Imaging

2018

Completed Phase 1

~630

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor

445 Previous Clinical Trials

145,610 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,696 Previous Clinical Trials

6,952,475 Total Patients Enrolled

6 Trials studying Liver Cancer

1,936 Patients Enrolled for Liver Cancer

Sidney Kimmel Cancer Center at Thomas Jefferson UniversityLead Sponsor

162 Previous Clinical Trials

10,807 Total Patients Enrolled

1 Trials studying Liver Cancer

23 Patients Enrolled for Liver Cancer

Media Library

Yttrium-90 Microsphere Radioembolization Clinical Trial Eligibility Overview. Trial Name: NCT03199274 — Phase 2

Liver Cancer Research Study Groups: Group I (perflutren protein-type A microspheres, CEUS), Group II (standard of care)

Liver Cancer Clinical Trial 2023: Yttrium-90 Microsphere Radioembolization Highlights & Side Effects. Trial Name: NCT03199274 — Phase 2

Yttrium-90 Microsphere Radioembolization 2023 Treatment Timeline for Medical Study. Trial Name: NCT03199274 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Yttrium-90 Microsphere Radioembolization been sanctioned for use by the FDA?

"Although there is some evidence of Yttrium-90 Microsphere Radioembolization's safety, no efficacy studies have been conducted and thus it has received a score of 2."

Answered by AI

How many participants have been recruited for this study thus far?

"Affirmative. Clinicaltrials.gov contains information that attests to this clinical trial's recruitment process, which began on July 1st 2017 and was last modified on November 16th 2022. The study requires 104 participants from a single site for completion."

Answered by AI

Are there any prior instances of Yttrium-90 Microsphere Radioembolization trials being conducted?

"Currently, 19 clinical trials for Yttrium-90 Microsphere Radioembolization are underway with 1 trial in Phase 3. These studies can be found at 26 different medical sites across the country; most of which are located within Philadelphia, Pennsylvania."

Answered by AI

For which medical conditions is Yttrium-90 Microsphere Radioembolization commonly prescribed?

"Yttrium-90 Microsphere Radioembolization is a common form of treatment for echocardiography and delineation of left ventricular endocardial borders, as well as other cardiovascular conditions."

Answered by AI

Are there opportunities for individuals to enroll in this experimental endeavor?

"Yes, the details published on clinicaltrials.gov indicate that recruitment for this trial is still open. It was first posted in July 2017 and last revised on November 16th 2022. The investigators are aiming to enroll 104 patients at a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

john eisenbrey 2017. "Perflutren Protein-Type A Microspheres and Contrast-Enhanced Ultrasound in Improving Response to Radioembolization Therapy in Patients With Liver Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03199274.

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