The AMARA (As Much As Reasonably Achievable) Study

U

University Hospital of Patras

Status

Enrolling

Conditions

Liver Cancer

Treatments

Device: Transarterial Radioembolization

Study type

Observational

Funder types

Other

Identifiers

NCT06257030
735

Details and patient eligibility

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.

Enrollment

100 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

TARE group
Description:
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
Treatment:
Device: Transarterial Radioembolization

Trial contacts and locations

1

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Central trial contact

Konstantinos Katsanos, Professor

Data sourced from clinicaltrials.gov

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