The AMARA (As Much As Reasonably Achievable) Study

Last updated: April 21, 2024
Sponsor: University Hospital of Patras
Overall Status: Active - Recruiting

Phase

N/A

Condition

Liver Disease

Digestive System Neoplasms

Liver Cancer

Treatment

Transarterial Radioembolization

Clinical Study ID

NCT06257030
735
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 andimaging 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 withliver specific contrast at 3mo, 6mo, 9mo, 1yr, 2.0 yr, and 3.0 years.

Exclusion

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.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Transarterial Radioembolization
Phase:
Study Start date:
February 05, 2024
Estimated Completion Date:
February 05, 2027

Connect with a study center

  • University Hospital of Patras

    Patra, Achaia 26500
    Greece

    Active - Recruiting

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