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Radiotherapy

Contrast-Enhanced Ultrasound for Intrahepatic Cholangiocarcinoma

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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 6 months post-transarterial radioembolization (tare)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Tumor complete response (CR) and partial response (PR)

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

Find a Location

Who is running the clinical trial?

Thomas Jefferson UniversityLead Sponsor
451 Previous Clinical Trials
148,658 Total Patients Enrolled

Media Library

Radioembolization Treatment (Radiotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT05328167 — Phase 2
Intrahepatic Cholangiocarcinoma Research Study Groups: Diagnostic (perflutren protein-type A microspheres, CEUS)
Intrahepatic Cholangiocarcinoma Clinical Trial 2023: Radioembolization Treatment Highlights & Side Effects. Trial Name: NCT05328167 — Phase 2
Radioembolization Treatment (Radiotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05328167 — Phase 2
~2 spots leftby Oct 2024
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