← Back to Search

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

No Placebo-Only Group

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 below

Select...

I am 22 years old or older.

Select...

I have a tumor in my adrenal gland.

Select...

I can care for myself and am up and about more than 50% of my waking hours.

Select...

My cancer has spread to my bones.

Select...

I have a kidney tumor, whether it's primary, metastatic, or benign.

Select...

I have a tumor that has a lot of blood vessels.

Select...

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.

Select...

My tumor is larger than 8 cm or makes up more than half of the affected organ.

Select...

I have had embolization for conditions other than blood-rich tumors.

Select...

My target lesion is supplied by major arteries or connected to them.

Select...

I am scheduled for another procedure on the same day as my main surgery.

Select...

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and immediately post-embolization procedure for reporting.

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