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Brachytherapy

Radioembolization with EYE90 Microspheres for Liver Cancer

N/A

Recruiting

Led By Andrew Kennedy, MD

Research Sponsored by ABK Biomedical

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

Study Summary

This trial will evaluate a medical device used to treat unresectable liver tumors with radiation.

Who is the study for?

This trial is for adults with unresectable Hepatocellular Carcinoma (HCC) who have a single liver tumor ≤ 8 cm or multiple tumors with a combined size of ≤ 12 cm. Participants must have at least one measurable lesion, no extra hepatic disease, and a life expectancy of over 6 months. They cannot join if they have severe kidney issues, blood disorders, compromised biliary systems, or are at risk for high radiation exposure to the lungs.Check my eligibility

What is being tested?

The study tests Eye90 microspheres®, which deliver targeted radiation directly to liver tumors using yttrium-90 (Y-90). The goal is to treat all lesions in one session and evaluate the effectiveness and safety of this local brachytherapy approach in patients with HCC.See study design

What are the potential side effects?

Potential side effects may include localized pain, nausea, fatigue due to radiation exposure; there's also a risk of damage to surrounding healthy liver tissue or other nearby organs from the radioactive material.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Duration of response (DoR)

Incidence of adverse events (AEs)

Incidence of serious adverse events (SAEs)

+1 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: EYE90 Microspheres TreatmentExperimental Treatment1 Intervention

Radioembolization with Eye90 Microspheres

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ABK BiomedicalLead Sponsor

1 Previous Clinical Trials

6 Total Patients Enrolled

1 Trials studying Liver Cancer

6 Patients Enrolled for Liver Cancer

Andrew Kennedy, MDPrincipal InvestigatorDirector, Radiation Oncology Research at Sarah Cannon

1 Previous Clinical Trials

26 Total Patients Enrolled

Aravind Arepally, MDStudy DirectorABK Biomedical, Inc

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project extend to senior citizens aged eighty or over?

"As defined by the parameters of this medical trial, individuals who are 18 years old or above can enroll, while those aged 99 and below qualify for participation."

Answered by AI

Is recruitment for this research initiative still open?

"Per the clinicaltrials.gov database, this research initiative is currently in need of participants and was initially posted on September 21st 2023 with its most recent update occurring on the 28th of that month."

Answered by AI

What is the total participant enrollment for this experiment?

"Affirmative. The information hosted on clinicaltrials.gov implies that this research is presently in need of participants; the study was first posted on September 21st 2023 and had its most recent update a week later. Currently, 120 patients are sought from one medical facility."

Answered by AI

Is it possible for me to take part in this research project?

"This clinical trial is accepting 120 participants, aged 18-99 years old with liver cancer. They must possess a verified diagnosis of HCC (as established by Liver Imaging Reporting and Data System [LIRADS] category 5 or biopsy), have no other hepatic diseases, have up to 3 lesions measuring ≥ 2 cm in long axis viewable on CT/CBCT/MRI scans (mRECIST criteria applied for target lesion definition) which individually are ≤ 8 cm and collectively ≤ 12 cm in size, be hypervascular on CBCT/CT/MRI imaging tests, demonstrate > 33% of total liver volume spared from treatment"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Radioembolization Trial Utilizing Eye90 Microspheres™ for the Treatment of Hepatocellular Carcinoma (HCC)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05953337.

All > Hcc > Hepatocellular Carcinoma