A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver

Clinical Trials.gov
21 Oct, 2019 ,

Indiana University is conducting an Interventional study in 50 participants in order to quantify the relationship between Y-90 liver therapy and liver damage as very little is known on this subject and present assumptions and calculations of Y-90 administration are based on surgical lobar hepatectomies and external radiation beam therapies.

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The investigators will be enrolling patients planning to receive Y-90 therapy for the treatment of liver malignancies. The diagnosis of a primary liver cancer, hepatocellular carcinoma (HCC), is usually made by a combination of specific imaging findings and clinical criteria; only rarely is a confirmatory biopsy performed. This is due to the high accuracy of the present diagnostic model and the significant risk of biopsy and tumor seeding.

Y-90 therapy involves administering radioactive particles to liver tumors by placing a catheter in a hepatic artery supplying the tumor using angiographic techniques and injection of these particles.

Y-90 Positron Emission Tomography-Computed Tomography (PET/CT) imaging has been established as a method to validate and quantitate distribution of Yttrium after Y-90 administration. The post Y-90 therapy PET/CT images provide an imaging distribution of the Y-90, which is essential for validation of administered versus planned dose to the liver lesion and background liver.

If the investigators can compare the Y-90 distribution to estimate background liver radiation distribution and dose (generated by the Y-90 PET/CT scan) combined with the global and regional function map (generated by the hepatobiliary [HIDA] scan performed before and after therapy), then the investigators will be assuming that the difference pre and post therapy in global and regional function can be ascribed to the Y-90 administration.

The investigators will also analyze the Magnetic Resonance Imaging (MRI) and CT sets performed before and after therapy and correlate the imaging results collected with clinical findings such as ascites/encephalopathy and routine serological markers (bilirubin, albumin, International normalized ratio [INR], etc.). With this information, the investigators will have the potential to establish whether there is a relationship between Y-90 distribution to non-tumoral (normal) hepatic parenchyma and the incidence and severity of Radioembolization-Induced Liver Disease (REILD). This would have the potential to improve selection criteria and outcomes in populations selected for Y-90 therapy in the future.