NCT06257030 The AMARA (As Much As Reasonably Achievable) Study
| NCT ID | NCT06257030 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital of Patras |
| Condition | Liver Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-05 |
| Primary Completion | 2027-02-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2024-02-05 with a primary completion date of 2027-02-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Platon Dimopoulos, Resident
STUDY DIRECTOR
University Hospital of Patras
Frequently Asked Questions
Who can join the NCT06257030 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06257030 currently recruiting?
Yes, NCT06257030 is actively recruiting participants. Contact the research team at katsanos@med.upatras.gr for enrollment information.
Where is the NCT06257030 trial being conducted?
This trial is being conducted at Pátrai, Greece.
Who is sponsoring the NCT06257030 clinical trial?
NCT06257030 is sponsored by University Hospital of Patras. The principal investigator is Platon Dimopoulos, Resident at University Hospital of Patras. The trial plans to enroll 100 participants.
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