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

Stopped early · Not applicable

Conditions studied: HCC, Liver Cancer

In brief

The primary question of interest is quantifying the relationship between Y-90 liver therapy and liver damage. Little is known on this subject. Present assumptions and calculations of Y-90 administration are based on surgical lobar hepatectomies and external radiation beam therapies. The investigators hope that by using a functional model of the liver, the investigators can improve this important knowledge gap. 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.

Key facts

Study ID

NCT02966223

Run by

Indiana University

People needed

20

Starts

2017-08-17

Expected to finish

2020-04-24

Last updated by the study team

2020-09-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects must have the ability to understand and the willingness to sign a written informed consent document.
• Subjects must be ≥ 18 years of age at the time of signing informed consent.
• Subjects must have a diagnosis of hepatocellular carcinoma (HCC) and a treatment plan to undergo radioembolization therapy with Y-90 at Indiana University Health Hospital.
• Subjects must be willing and able to comply with all procedures and visits required for this protocol (pre-treatment, during treatment, and post-treatment).

You may not qualify if…

• Subjects who have contraindications for receiving Y-90 therapy and any routine procedures and imaging associated with Y-90 therapy, including subjects who are pregnant or are planning to become pregnant, will not be eligible to participate in this study. Female subjects who are of childbearing potential should inform her treating physician should she become pregnant at any time during the course of the study.
• Subjects with contraindications for receiving hepatobiliary scans (HIDA scans) and Magnetic Resonance Imaging (MRI scans) will not be eligible to participate in this study.

Where it is running

• Indiana University Hospital — Indianapolis, Indiana, United States

Full record on ClinicalTrials.gov

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