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

NCT02966223 | Terminated Results DMC FDA Device

• 1 other identifier: RADY-BTG-TANN-HIDA/0603
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HCC; Liver Cancer

Outcome Measures

Primary Outcomes (1)

• Primary

  Difference in regional liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.

  3 months

Secondary Outcomes (2)

• Secondary

  3 months

• Secondary

  6 months

Study Arms (1)

MRI and HIDA scan

EXPERIMENTAL

Radiation: MRI and HIDA scan

Interventions

MRI and HIDA scan RADIATION

Pre y90 therapy each subject will undergo a HIDA and MRI scan. 3 months post Y90 - Each subject will undergo a second HIDA scan and MRI scan

MRI and HIDA scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Indiana University: lead
• BTG International Inc.: collaborator

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Liver Neoplasms

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Limitations and Caveats

The trial was halted prematurely because sponsor withdrew funding. There is insufficient data to analyze.

Results Point of Contact

• Title: Mark Tann, MD
• Organization: Indiana University

matann@iupui.edu

317- 948-8782

Study Officials

• Mark Tann, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Radiology

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 17, 2016
• Study Start: August 17, 2017
• Primary Completion: July 15, 2019
• Study Completion: April 24, 2020
• Last Updated: September 25, 2020
• Results First Posted: September 25, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)