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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 belowSelect...
I am 18 years old or older.
Select...
I am scheduled for a specific liver cancer treatment for a tumor larger than 1 cm but smaller than 6 cm.
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)
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
445 Previous Clinical Trials
145,469 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am of childbearing age and have a negative pregnancy test before each ultrasound.I have had a recent brain bleed.I was born with a heart defect.I am 18 years old or older.I have severe lung problems or a history of blood clots in my lungs.I am not pregnant or nursing.I am scheduled for a specific liver cancer treatment for a tumor larger than 1 cm but smaller than 6 cm.
Research Study Groups:
This trial has the following groups:- Group 1: Diagnostic (perflutren protein-type A microspheres, CEUS)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Contrast-Enhanced Ultrasound a reliable diagnostic tool?
"While Phase 2 trials don't offer much data in support of a medication's efficacy, Contrast-Enhanced Ultrasound still received a score of 2 for safety."
Answered by AI
Can newly recruited participants join this trial at this time?
"That is correct, the clinical trial indicated on clinicaltrials.gov is still searching for enrollees. The 20 patients will come from a single location, and the posting dates you mentioned are accurate."
Answered by AI
How many total patients will be enrolled in this experiment?
"Yes, the trial is still open for recruitment and information on clinicaltrials.gov supports this assertion. The trial was first posted on December 14th 2021 with the most recent update taking place on April 7th, 2022. 20 individuals are needed to participate at 1 site."
Answered by AI
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