NCT06257030Recruiting
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 · Last updated 24 Apr 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 5 Feb 2024
- Start date
- 5 Feb 2024
- Primary completion date
- 5 Feb 2027
- Lead sponsor
- University Hospital of Patras
- Diseases
- Liver and biliary tract cancer
- NCT number
- NCT06257030
What you commit to
- Study type: Observational
- Planned participants: 100
- From 5 Feb 2024 to the primary completion date, 5 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Multi-focal bilobar disease
- Disseminated extrahepatic disease
Lab values
- Bilirubin \>2 mg/dl
- Albumin\<3.0
Other
- Child Pugh \> B
- Central portal invasion
- Lung shunt \>20% or a estimated Lung dose \> 20 Gy
- Focuses of extra-hepatic liver uptake.
- Patients that cannot tolerate addition follow-up imaging.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital of Patras Coordinator of this site? Confirm its status | Pátrai | Greece | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.