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Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

Clinical Trial Details

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of participants with unresectable Hepatocellular Carcinoma (HCC, a.k.a. liver cancer).

Eye90 is comprised of tiny glass beads containing yttrium-90 (Y90), a radioactive material. The beads are delivered in and around the tumor(s) through a tiny catheter placed through the artery of the groin or wrist and into one or more branches of the artery of the liver under x-ray camera guidance.

Eye90 is a new medical device that resembles and aims to improve upon two devices that have been used safely worldwide over the last 20 years. While these older devices, (SIR-Spheres and TheraSphere), are approved by the U.S. Food and Drug Administration (FDA), Eye90 is considered investigational, which means it is not yet approved by the FDA.

Total study participation is expected to last 1 year. Participants will be followed clinically and with imaging during this time and then will continue to receive standard of care after study participation.

Key Eligibility: 

1. Age of 18 years or older
2. Diagnosis of Hepatocellular Carcinoma (HCC) confirmed by imaging or biopsy
3. Up to 3 tumors no larger than 8 cm diameter.
4. No tumors located outside of the liver.
5. Preserved liver function.

Detailed eligibility will be discussed with interested candidates by the study team.

Study contact by location

Upper East Side - Manhattan

Contact(s)

Brooklyn

Contact(s)

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

2401026926

ClinicalTrials.gov:

NCT05953337

Sponsor:

ABK Biomedical

Status

Open to Enrollment

Age Group

Adult

Sponsor