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Radiotherapy

Contrast-Enhanced Ultrasound for Bile Duct Cancer

Phase 2

Recruiting

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 at least 18 years of age

Be scheduled for sub-lobar radioembolization therapy of a previously untreated intrahepatic cholangiocarcinoma greater than 1 cm but small enough to be fully visualized in the ultrasound three-dimensional (3D) volume (approximately 6 cm maximum diameter, but depth dependent)

Must not have

Patients with recent cerebral hemorrhage

Patients with known congenital heart defects

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months post-transarterial radioembolization (tare)

Awards & highlights

Approved for 5 Other Conditions

All Individual Drugs Already Approved

No Placebo-Only Group

Summary

This trial is testing whether a type of ultrasound that uses gas microbubbles can predict how well bile duct cancer will respond to targeted radiotherapy. The ultrasound may also help doctors see if microbubble popping can improve bile duct cancer response to radiotherapy.

Who is the study for?

This trial is for adults with untreated intrahepatic cholangiocarcinoma (bile duct cancer) that's larger than 1 cm but small enough to be seen in a 3D ultrasound. Participants must be medically stable and not pregnant if female of child-bearing age. Exclusions include recent cerebral hemorrhage, pregnancy, high bilirubin levels, allergy to perflutren or albumin, congenital heart defects, severe lung conditions.

What is being tested?

The study tests if contrast-enhanced ultrasound can predict how well bile duct cancer responds to radioembolization treatment. It involves using gas microbubbles in the ultrasound which may pop and potentially make tumors more susceptible to radiotherapy. The trial also examines whether tumor pressure measured by ultrasound predicts treatment response.

What are the potential side effects?

Potential side effects might include allergic reactions to the microbubble contrast agent (perflutren), discomfort from the procedure itself, and any risks typically associated with ultrasounds such as minor pain or bruising at the injection site.

Eligibility Criteria

Inclusion Criteria

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

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I am 18 years old or older.

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I am scheduled for a specific liver cancer treatment for a tumor larger than 1 cm but smaller than 6 cm.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a recent brain bleed.

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I was born with a heart defect.

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I have severe lung problems or a history of blood clots in my lungs.

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I am not pregnant or nursing.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months post-transarterial radioembolization (tare)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months post-transarterial radioembolization (tare)

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months post-transarterial radioembolization (tare) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Tumor complete response (CR) and partial response (PR)

Awards & Highlights

Approved for 5 Other Conditions

This treatment demonstrated efficacy for 5 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Diagnostic (perflutren protein-type A microspheres, CEUS)Experimental Treatment2 Interventions

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Contrast-Enhanced Ultrasound

2018

Completed Early Phase 1

~50

0 / 6Eligibility criteria met