Radioembolization for large inoperable liver tumors
Studies a high-dose radiation treatment delivered to liver tumors in adults with liver cancer.
Plain-language title generated from the registry record
Registry title: The AMARA (As Much As Reasonably Achievable) Study
Key facts
- Where
- Pátrai, GreeceSee the site
Where in Greece
- University Hospital of PatrasPátrai, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University Hospital of Patras
- Trial code
- NCT06257030
- Record updated
- 24 April 2024
- Original description
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.Read full original descriptionShow less
The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
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.
Inclusion: 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: Multi-focal bilobar disease; Disseminated extrahepatic disease; Bilirubin >2 mg/dl; Albumin<3.0; Child Pugh > B; Central portal invasion; Lung shunt >20% or a estimated Lung dose > 20 Gy; Focuses of extra-hepatic liver uptake; Patients that cannot tolerate addition follow-up imaging.