The AMARA (As Much As Reasonably Achievable) Study

Launched by UNIVERSITY HOSPITAL OF PATRAS · Feb 5, 2024

Keywords

ClinConnect Summary

The AMARA Study is a clinical trial designed to investigate a new treatment for patients with large liver tumors that cannot be surgically removed. Specifically, the study is looking at a procedure called Y90 high dose radioembolization, which aims to deliver targeted radiation directly to the tumors. Researchers want to see how safe and effective this treatment is, especially for tumors larger than 5 centimeters. They will also use advanced imaging technology to monitor how the treatment affects the tumors and to ensure the safety of the patients involved.

To participate in the study, individuals must be at least 18 years old and have either primary or secondary liver tumors, with at least one lesion larger than 5 cm. Participants should be able to tolerate various imaging tests and must have a life expectancy of more than three months. Throughout the trial, patients will undergo multiple imaging sessions to track their progress over a period of up to three years. It’s important to note that individuals with certain health issues, such as severe liver disease or widespread cancer, may not be eligible for this study. Overall, the AMARA Study aims to provide valuable information that could improve treatment options for people with difficult-to-treat liver cancer.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age \>18 yr
• • Both sexes eligible for study
• • Patients with primary or secondary liver tumors
• • Liver dominant disease
• • At least one lesion greater than 5.0 cm in maximum diameter
• • Life-expectancy \> 3 months
• • FLR \>40% or greater than 500mls
• • Must be able to tolerate pre-treatment CT scan , DSA and 99mTc-MAA infusion and imaging with SPECT/CT scan
• • Able to schedule and tolerate post-treatment Y90 PET/CT imaging
• • Able to tolerate follow-up imaging with dynamic contrast CT liver phase or MRI with liver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.
• Exclusion Criteria:
• • Child Pugh \> B
• • Bilirubin \>2 mg/dl
• • Albumin\<3.0
• • Central portal invasion
• • Multi-focal bilobar disease
• • Disseminated extrahepatic disease
• • Lung shunt \>20% or a estimated Lung dose \> 20 Gy
• • Focuses of extra-hepatic liver uptake.
• • Patients that cannot tolerate addition follow-up imaging.