The AMARA (As Much As Reasonably Achievable) Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transarterial Radioembolization.
- Who it may be relevant to
- Registry conditions: Liver Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Greece
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
Overview
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.
Interventions
- Device Transarterial Radioembolization
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
Primary outcome measures
- Complications [Time frame: 6 months]
- LPFS [Time frame: 2 years]
- Tumor Response [Time frame: 2 years]
Secondary outcome measures (1)
- Post-treatment dosimetry analysis [Time frame: 2 years]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Greece · 1 center
- University Hospital of Patras — Pátrai
Identifiers
NCT: NCT06257030 · 735