Evaluating high dose radioembolization for large inoperable liver tumors
The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
This study is testing if a high dose of a treatment called Y90 radioembolization can safely shrink large liver tumors that can’t be surgically removed.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital of Patras Academic / other |
| Locations | 1 site (Pátrai, Achaia) |
| Trial ID | NCT06257030 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with large inoperable liver tumors, specifically those with at least one lesion larger than 5 cm. It aims to assess the safety and efficacy of Y90 high dose radioembolization, utilizing the AMARA principle to deliver a planned irradiated tumor dose greater than 200 Gy. The study will also correlate treatment outcomes with post-treatment dosimetry analysis using advanced imaging techniques. Participants will undergo various imaging procedures to monitor their condition and treatment response over time.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 with primary or secondary liver tumors that are dominant in the liver and have at least one lesion greater than 5 cm.
Not a fit: Patients with Child Pugh score greater than B, significant liver dysfunction, or extrahepatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a new effective treatment option for patients with large inoperable liver tumors.
How similar studies have performed: Other studies have shown promising results with radioembolization techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pátrai, Achaia
- University Hospital of Patras — Pátrai, Achaia, Greece (Recruiting)
Study contacts
- Study coordinator: Konstantinos Katsanos, Professor
- Email: katsanos@med.upatras.gr
- Phone: +306978225019
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.