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Procedure
Embolization Techniques for Liver Cancer
Phase 2
Waitlist Available
Led By Michael C Soulen, MD, FSIR
Research Sponsored by University of Pennsylvania
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Participants 18 years and older
Biopsy-proven neuroendocrine tumor
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether chemoembolization is more effective than bland embolization for treating liver cancer.
Who is the study for?
Adults with biopsy-proven neuroendocrine tumors and liver metastases, who have symptoms uncontrolled by medication or progressive tumors. They must be in fairly good health (Zubrod/ECOG Performance Scale 0-2), not pregnant, and not planning other treatments during the trial. Exclusions include active infections, certain allergies to contrast media, prior hepatic artery therapy or radiation (except surgery or ablation), and severe vascular disease.Check my eligibility
What is being tested?
The study is testing three types of embolization procedures on liver metastases from neuroendocrine tumors: bland embolization (BE), transarterial chemoembolization (TACE) using Lipiodol, and drug-eluting beads embolization (DEB). The goal is to compare how long each treatment can stop tumor growth in the liver without progression.See study design
What are the potential side effects?
Possible side effects may include abdominal pain, fever, nausea, infection at the catheter site, allergic reactions to materials used during procedures like contrast dye for imaging tests. There's also a risk of liver damage due to blocking blood flow.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
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My tumor is confirmed to be neuroendocrine through a biopsy.
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I have a liver metastasis larger than 1 cm.
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I am not planning to receive any other treatments besides the trial, except for medications for hormone regulation or bone strength.
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I can take care of myself but might not be able to do heavy physical work.
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Most of my cancer is in the liver, but it takes up 70% or less of my liver.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Abdominal MRI/Triple Phase CT
Secondary outcome measures
Number of Adverse Events
Trial Design
3Treatment groups
Experimental Treatment
Group I: Arm 3 - DEB - CLOSEDExperimental Treatment1 Intervention
Lobar or segmental hepatic chemoembolization with DEBDOX (100-300 or 300-500 micron beads loaded with doxorubicin per manufacturer IFU monthly until entire tumor burden is treated.
Group II: Arm 2 - TACEExperimental Treatment1 Intervention
Lobar or segmental lipiodol conventional transarterial chemoembolization (TACE). Doxorubicin 50 mg dissolved in 10 mL dilute contrast and emulsified with 10-20 cc iodized oil, followed by 50-500 μm microspheres.
Group III: Arm 1 - BEExperimental Treatment1 Intervention
Lobar or segmental bland embolization (BE) with microspheres (50-500 microns) to 2-5 heartbeat stasis.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Transarterial chemoembolization
2019
Completed Phase 3
~1010
Find a Location
Who is running the clinical trial?
University of PennsylvaniaLead Sponsor
2,009 Previous Clinical Trials
42,894,491 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
1,049 Patients Enrolled for Neuroendocrine Tumors
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,482 Total Patients Enrolled
2 Trials studying Neuroendocrine Tumors
62 Patients Enrolled for Neuroendocrine Tumors
GuerbetIndustry Sponsor
68 Previous Clinical Trials
93,560 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.My tumor is confirmed to be neuroendocrine through a biopsy.I have a liver metastasis larger than 1 cm.I've had liver treatments but am 1 month past these and recovered from side effects.I do not have an active infection requiring treatment.I have had surgery or a procedure to improve bile flow from my liver.My symptoms are not managed by my current medication, or my liver tumor is growing, or more than a quarter of my liver is affected by the tumor.I am not planning to receive any other treatments besides the trial, except for medications for hormone regulation or bone strength.I can take care of myself but might not be able to do heavy physical work.I cannot have IV contrast due to a severe past reaction.I do not have specific liver blood flow issues or brain conditions related to liver disease.I cannot have surgery for my condition due to various reasons.Most of my cancer is in the liver, but it takes up 70% or less of my liver.I cannot undergo certain blood vessel imaging due to severe allergies, bleeding issues, or severe blood vessel disease.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 1 - BE
- Group 2: Arm 2 - TACE
- Group 3: Arm 3 - DEB - CLOSED
Awards:
This trial has 1 awards, including:- 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 this research project still enrolling individuals?
"Data from clinicaltrials.gov suggests that this study is not presently looking for participants. This trial was originally posted on March 1st, 2016 and was last updated on May 3rd, 2022. There are 842 other trials currently enrolling patients."
Answered by AI
Did the FDA grant approval for Transarterial chemoembolization?
"Transarterial chemoembolization is a Phase 2 treatment, so there is some data supporting its safety. However, because this is not a Phase 3 treatment, there is no evidence demonstrating its efficacy."
Answered by AI
Do we have a clear understanding of how many locations are testing this hypothesis?
"Enrollment for this study is currently ongoing at 9 clinical sites, which are situated in Toronto, Milwaukee, San Francisco as well as 6 other cities. To limit travel burdens, it would be best to select a location nearest you."
Answered by AI
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