Actively Recruiting
The AMARA (As Much As Reasonably Achievable) Study
Led by University Hospital of Patras · Updated on 2024-04-24
100
Participants Needed
1
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The AMARA (As Much As Reasonably Achievable) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years
- Both sexes eligible
- Patients with primary or secondary liver tumors
- Liver dominant disease
- At least one lesion greater than 5.0 cm in maximum diameter
- Life expectancy greater than 3 months
- Future liver remnant (FLR) greater than 40% or more than 500 milliliters
- Able to tolerate pre-treatment CT scan, digital subtraction angiography (DSA), and 99mTc-MAA infusion with SPECT/CT imaging
- 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 3, 6, 9 months, 1 year, 2 years, and 3 years
You will not qualify if you...
- Child Pugh score greater than B
- Bilirubin level greater than 2 mg/dl
- Albumin level less than 3.0
- Central portal vein invasion
- Multi-focal bilobar liver disease
- Disseminated disease outside the liver
- Lung shunt greater than 20% or estimated lung radiation dose greater than 20 Gy
- Presence of extra-hepatic liver uptake
- Unable to tolerate additional follow-up imaging
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
University Hospital of Patras
Pátrai, Achaia, Greece, 26500
Actively Recruiting
Research Team
K
Konstantinos Katsanos, Professor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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