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Embolization Agent
Instylla HES for Cancer Embolization Treatment
N/A
Waitlist Available
Led By Nadine Abi-Jaoudeh, M.D.
Research Sponsored by Instylla, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female subjects age ≥ 22 years old
Subjects with adrenal tumors
Must not have
For subjects with HCC or undergoing embolization to the liver: Child-Pugh Class C or presence of complete portal vein thrombosis.
Tumor lesions > 8 cm in diameter (in one direction) or >50% tumor volume burden of the target organ
Timeline
Screening 3 weeks
Treatment Varies
Follow Up immediately post-embolization procedure
Awards & highlights
Summary
This trial is comparing Instylla HES to standard of care transarterial embolization/conventional transarterial chemoembolization to see if it is effective and safe.
Who is the study for?
Adults aged 22 or older with hypervascular tumors, including adrenal, renal, bone metastases, and unresectable liver cancers. Participants must have a life expectancy of at least 6 months post-treatment and be able to give informed consent. They should not have severe allergies to trial materials or major organ dysfunction.
What is being tested?
The study is testing Instylla HES's ability to block blood flow in tumor arteries against the standard embolization treatments (TAE/cTACE). The goal is to see if it's just as good while keeping serious side effects low.
What are the potential side effects?
Potential side effects may include reactions related to blocking blood vessels that feed tumors and those specific to the Instylla HES material. Serious adverse events will be closely monitored.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 22 years old or older.
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I have a tumor in my adrenal gland.
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I can care for myself and am up and about more than 50% of my waking hours.
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My cancer has spread to my bones.
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I have a kidney tumor, whether it's primary, metastatic, or benign.
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I have a tumor that has a lot of blood vessels.
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My liver cancer cannot be removed by surgery.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have severe liver disease or a complete blockage in the liver's main blood vessel.
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My tumor is larger than 8 cm or makes up more than half of the affected organ.
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I have had embolization for conditions other than blood-rich tumors.
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My target lesion is supplied by major arteries or connected to them.
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I am scheduled for another procedure on the same day as my main surgery.
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I need a specific liver tumor treatment through an artery outside the liver.
Select...
I have severe artery disease that prevents catheter use.
Select...
I am receiving specific liver cancer treatments.
Select...
I have had surgery or procedures on my bile ducts, including stents or sphincterotomy.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ immediately post-embolization procedure
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~immediately post-embolization procedure
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Primary Effectiveness Endpoint: Delivery of the embolic agent to the index tumor feeding vessel with stasis of flow as determined by an independent radiologist via comparison of the pre and final post procedure images
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Instylla HESExperimental Treatment1 Intervention
Group II: ControlActive Control1 Intervention
TAE or cTACE
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Who is running the clinical trial?
Instylla, Inc.Lead Sponsor
1 Previous Clinical Trials
118 Total Patients Enrolled
Nadine Abi-Jaoudeh, M.D.Principal InvestigatorUniversity of California, Irvine
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had radioembolization on the tumor area within the last 30 days.You have ongoing health issues or complications from previous treatments that may not benefit from participating in the study or could potentially put your safety at risk. This includes conditions like ongoing infections, kidney problems, severe obesity, or serious heart disease.My tumor is hypervascular and I need a specific artery-blocking treatment.I am 22 years old or older.I have a tumor in my adrenal gland.I can care for myself and am up and about more than 50% of my waking hours.Not all my blood vessels needing treatment can be treated with standard methods.I have severe liver disease or a complete blockage in the liver's main blood vessel.I understand the study details and have signed the consent form.My tumor is larger than 8 cm or makes up more than half of the affected organ.I have had embolization for conditions other than blood-rich tumors.My target lesion is supplied by major arteries or connected to them.I have a blood vessel smaller than 5mm that can be treated with Instylla HES.I am scheduled for another procedure on the same day as my main surgery.I need a specific liver tumor treatment through an artery outside the liver.I have severe artery disease that prevents catheter use.My last Avastin dose was within the last 4 weeks.I am not pregnant, breastfeeding, nor planning to become pregnant soon.My cancer has spread to my bones.I have a kidney tumor, whether it's primary, metastatic, or benign.I have a tumor that has a lot of blood vessels.Your doctor believes you will live for at least 6 more months after the embolization procedure.My liver cancer cannot be removed by surgery.I am receiving specific liver cancer treatments.I have had surgery or procedures on my bile ducts, including stents or sphincterotomy.
Research Study Groups:
This trial has the following groups:- Group 1: Control
- Group 2: Instylla HES
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.
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