Liver Cancer
Conditions
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.
Interventions
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
Sponsors
University Hospital of Patras
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complications | 6 months | Adverse Events related with the procedure |
| LPFS | 2 years | Liver Progression Free Survival after the procedure |
| Tumor Response | 2 years | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment dosimetry analysis | 2 years | Correlate the safety and efficacy with the post-treatment dosimetry analysis |
Countries
Greece
Contacts
Primary ContactKonstantinos Katsanos, Professor
Outcome results
None listed