The AMARA (As Much As Reasonably Achievable) Study

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.

Study Overview

• Status: Recruiting
• Conditions: Liver Cancer
• Intervention / Treatment: Device: Transarterial Radioembolization

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Konstantinos Katsanos, Professor; Phone Number: +306978225019; Email: katsanos@med.upatras.gr

Study Locations

• Greece
  • Achaia
    • Patra, Achaia, Greece, 26500
      • Recruiting
      • University Hospital of Patras
      • Contact: Theoni Kaplanidou; Phone Number: 006973424965; Email: theoni.kaplanidou@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals presenting with either primary or metastatic hepatic malignancies are the study population.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Adverse Events related with the procedure	6 months
LPFS	Liver Progression Free Survival after the procedure	2 years
Tumor Response	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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-treatment dosimetry analysis	Correlate the safety and efficacy with the post-treatment dosimetry analysis	2 years

Collaborators and Investigators

• Sponsor: University Hospital of Patras
• Investigators: Study Director: Platon Dimopoulos, Resident, University Hospital of Patras

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2024
• Primary Completion (Estimated): February 5, 2027
• Study Completion (Estimated): February 5, 2027

Study Registration Dates

• First Submitted: February 5, 2024
• First Submitted That Met QC Criteria: February 5, 2024
• First Posted (Actual): February 13, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms
• Other Study ID Numbers: 735

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes