An observational study in Liver Cancer, sponsored by University Hospital of Patras. Recruiting at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-24.
Sponsored by University Hospital of Patras · Observational
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.
1,391 studies on the registry are indexed under Liver Neoplasms; 345 are open to participants now.
This study's planned enrollment of 100 is below the median of 200 across 350 observational studies indexed under Liver Neoplasms.
Browse Liver Neoplasms studies →University Hospital of Patras is the lead sponsor of 42 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Individuals presenting with either primary or metastatic hepatic malignancies are the study population.
Exclusion Criteria:
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
Device: Transarterial Radioembolization
(TARE)Transarterial radioembolization is a transcatheter intra-arterial procedure performed by the interventional radiologist for the treatment of primary and secondary hepatic cancers.
Complications
Adverse Events related with the procedure
Time frame: 6 months
LPFS
Liver Progression Free Survival after the procedure
Time frame: 2 years
Tumor Response
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.
Time frame: 2 years
Post-treatment dosimetry analysis
Correlate the safety and efficacy with the post-treatment dosimetry analysis
Time frame: 2 years
Plan to share: No
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University Hospital of Patras