Clinical trial · Observational
The AMARA (As Much As Reasonably Achievable) Study
The AMARA (As Much As Reasonably Achievable) Study: Radioembolization of Large Inoperable Liver Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Transarterial Radioembolization | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 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.
- interventionNames
- Device: Transarterial Radioembolization
Primary outcomes (3)
- measure
- Complications
- timeFrame
- 6 months
- description
- Adverse Events related with the procedure
- measure
- LPFS
- timeFrame
- 2 years
- description
- Liver Progression Free Survival after the procedure
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available