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Radioembolization with Eye90 Microspheres

Eye90 Microspheres

Robert Abraham, MD, FSIR

The purpose of this study is to evaluate the safety of treatment with Eye90 microspheres in patients with unresectable Hepatocellular Carcinoma (HCC) and metastatic Colorectal Cancer (mCRC). Both cause tumors, known as malignant hyper-vascular hepatic neoplasia, that have an abnormally large number of blood vessels attached to them. Eye90 is internal radiation brachytherapy for treatment of malignant hyper-vascular hepatic neoplasia that uses microspheres, tiny glass beads smaller in diameter than a human hair, to provide radiation. The microspheres contain Yttrium-90 (Y90) as the radiation source, which are used to to kill cancer cells and shrink tumors. The microspheres are also radiopaque, which means that they can be seen during imaging procedures. The visibility of the microspheres allows the study doctor to confirm the microspheres have been delivered in the tumor; this may help to improve the outcome of treatment.

Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC

Investigation of Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable Hepatocellular Carcinoma (HCC) and Metastatic Colorectal Cancer (mCRC)

Incidence of Adverse Events ≥ Grade 3 according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

Incidence of Related Treatment Emergent Serious Adverse Events (TESAEs) according to Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

ORR is defined at Complete or Partial Response using local RECIST 1.1 compared to baseline

ORR is defined at Complete or Partial Response using local mRECIST compared to baseline

ABK Biomedical

EYE90 Microspheres Treatment

Study Coordinator

Nadine Abi-Jaoudeh, MD

Robert Martin, MD

Ammar Sarwar, MD

Eric Wang, MD

Andrew Kennedy, MD

Ziga Cizman, MD

Aravind Arepally, MD

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of subjects with unresectable Hepatocellular Carcinoma (HCC). Eye90 microspheres is a medical device containing yttrium-90 (Y-90), a radioactive material, and provides local radiation brachytherapy for the treatment of liver tumors.

Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)

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

The percentage of subjects with ORR using local mRECIST, as assessed by independent panel review.

DoR is defined as response ≥ 6 months for ≥ 60% of responders first occurrence of CR or PR

Incidence of AEs, grouped by System Organ Class (SOC) and Preferred Term (PT), relatedness to study treatment/procedure, and severity.

Incidence of SAEs, grouped by SOC and PT, relatedness to study treatment/procedure, and severity.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety and Effectiveness of Eye90 Microspheres™ in the Treatment of Unresectable HCC and mCRC	NCT04926376	Hepatocellular ... Metastatic Colo... Liver Cancer	Eye90 Microsphe...	18 Years - 99 Years	ABK Biomedical
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)	NCT05953337	Hepatocellular ... Hepatocellular ... Liver Cancer	EYE90 Microsphe...	18 Years - 99 Years	ABK Biomedical
Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)	NCT05953337	Hepatocellular ... Hepatocellular ... Liver Cancer	EYE90 Microsphe...	18 Years - 99 Years	ABK Biomedical

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