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NCT Number: NCT06257030

The AMARA (As Much As Reasonably Achievable) Study

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.

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Patras

Pátrai, Achaia, 26500, Greece

Location status: Recruiting

Location contact

Theoni Kaplanidou

CONTACT

[email protected]

006973424965

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transarterial Radioembolization

Device

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

Primary outcomes

  1. Complications

    Time frame: 6 months

    Adverse Events related with the procedure

  2. LPFS

    Time frame: 2 years

    Liver Progression Free Survival after the procedure

  3. Tumor Response

    Time frame: 2 years

    Complete Response will be measured with the LI-RADS criteria for treatment response (LR-TR). In addition, RECIST v1.1, mRECIST, and PET-RECIST criteria will be further evaluated.

Secondary outcomes

  1. Post-treatment dosimetry analysis

    Time frame: 2 years

    Correlate the safety and efficacy with the post-treatment dosimetry analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Konstantinos Katsanos, Professor

CONTACT

[email protected]

+306978225019

Sponsors and collaborators

Lead sponsor

University Hospital of Patras

Other

Registry information

Official study title

The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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