RecruitingNCT06257030

The AMARA (As Much As Reasonably Achievable) Study

The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors

Sponsor

University Hospital of Patras

Enrollment

100 participants

Start Date

Feb 5, 2024

Study Type

OBSERVATIONAL

Conditions

Liver Cancer

Summary

Subjects with large inoperable liver tumors defined as at least 1 lesion larger than 5cm in maximum diameter. For the purposes of the present study, we define the AMARA principle in intensified regional TARE as a planned irradiated tumor dose \>200Gy by the partition model. The purpose of the study is to evaluate the safety and efficacy of Y90 high dose radioembolization for the management of large inoperable liver tumors. In addition, to correlate the safety and efficacy with the post-treatment dosimetry analysis (by MIM Software Inc) based on 90Y-PET/CT imaging.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study, called the AMARA study, is exploring high-dose targeted radiation therapy (Y-90 radioembolization) for people with liver tumors. The goal is to deliver as much radiation as safely possible directly to liver tumors while protecting healthy liver tissue. **You may be eligible if...** - You are over 18 years old - You have primary or secondary liver tumors (cancer that started in or spread to the liver) - Most of your cancer burden is in the liver - At least one tumor is larger than 5 cm - Your expected survival is more than 3 months - You have enough healthy liver remaining and can tolerate the required scans and procedures **You may NOT be eligible if...** - Your liver function is significantly impaired (Child-Pugh score above B) - Your bilirubin or other liver markers are too high - The main blood vessel into your liver is blocked by the tumor - You have cancer spread throughout both sides of the liver or widely outside the liver - Too much radiation would reach the lungs (lung shunt above 20%) - You cannot tolerate the required follow-up imaging over 3 years Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICETransarterial Radioembolization

(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.