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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

AI summary: who the study is looking for

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with large liver tumors that cannot be removed by surgery. At least one tumor must be larger than 5.0 cm (2 in).

Age
Over 18 years
Sex
Both sexes can join
Disease stage
Primary or secondary liver tumors, with the disease mainly in the liver. At least one tumor larger than 5.0 cm (2 in) across. Life expectancy over 3 months.

Main reasons for not taking part

  • Child Pugh score above B
  • Bilirubin above 2 mg/dl or albumin below 3.0
  • Cancer spread into the central portal vein
  • Many tumors in both lobes of the liver, or widespread disease outside the liver
  • Lung shunt above 20% or estimated lung dose above 20 Gy

Read by machine on 12 November 2026.

Where in Greece

  • University Hospital of PatrasPátrai, GreeceContact: Theoni KaplanidouTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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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.

ClinicalTrials.gov NCT06257030