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

Primary Purpose

HCC, Liver Cancer

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI and HIDA scan
Sponsored by
Indiana University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for HCC

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subjects must have the ability to understand and the willingness to sign a written informed consent document.
  2. Subjects must be ≥ 18 years of age at the time of signing informed consent.
  3. 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.
  4. Subjects must be willing and able to comply with all procedures and visits required for this protocol (pre-treatment, during treatment, and post-treatment).

Exclusion Criteria:

  1. 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.
  2. Subjects with contraindications for receiving hepatobiliary scans (HIDA scans) and Magnetic Resonance Imaging (MRI scans) will not be eligible to participate in this study.

Sites / Locations

  • Indiana University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRI and HIDA scan

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Secondary
Determine the difference in global liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.
Secondary
Correlation between the differences in liver function (both regional and global) with the Y 90 dose provided.

Full Information

First Posted
November 8, 2016
Last Updated
September 23, 2020
Sponsor
Indiana University
Collaborators
BTG International Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02966223
Brief Title
A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver
Official Title
A Study to Assess the Effect of Y-90 Therapy on Non-target/Background Liver
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Sponsor prematurely withdrew financial support.
Study Start Date
August 17, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Actual)
Study Completion Date
April 24, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
Collaborators
BTG International Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Little is known on the potential relationship between Y-90 liver therapy and liver damage this subject. Present assumptions and calculations of Y-90 administration are based on surgical lobar hepatectomies and external radiation beam therapies. As most participants that need Y90 based liver therapies have compromised livers, the importance of knowing what potential collateral liver damage could be induced by Y90 is key so as not induce liver failure. Successful treatment of a liver malignancy would not be important if the potential mortality/morbidity risk of the treatment is higher or equal to the existing malignancy. As apposed to anatomical imaging looking for changes in size/shape which are late changes, the investigators hope that by using a functional model of the liver, which can show early changes of liver damage, the investigators can improve the sensitivity for detection of liver damage and bridge this important knowledge gap. Additionally due to compensatory hypertrophy of the non treated liver, potential liver damage estimated by lab tests may be masked, again this emphasizes the importance of the measurement of the functional approach before and after therapy. The investigators will be enrolling participants 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 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. The investigators will be performing both specialized nuclear medicine HIDA and MRI scans aimed at constructing a functional map of the liver before and 3 months after therapy. The investigators will 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 HIDA and MRI scans 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 MRI and NM data 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, 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 REILD. This would have the potential to improve selection criteria and outcomes in populations selected for Y-90 therapy in the future.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
HCC, Liver Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MRI and HIDA scan
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
MRI and HIDA scan
Intervention Description
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
Primary Outcome Measure Information:
Title
Primary
Description
Difference in regional liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Secondary
Description
Determine the difference in global liver function between pre and 3 months post Yttrium 90 delivery using the HIDA functional imaging scans.
Time Frame
3 months
Title
Secondary
Description
Correlation between the differences in liver function (both regional and global) with the Y 90 dose provided.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Tann, MD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Indiana University Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share

Learn more about this trial

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

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