Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System

NCT ID: NCT03889093

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-09
• Study Completion Date: 2022-02-24

Brief Summary

The goal of this study is to understand the immunologic effects radioembolization has on the immune system. This will be done by evaluating the changes on biopsy, peripheral blood monocytes, and cytokines.

Detailed Description

This is a single institution non-interventional study designed to evaluate the immune reaction to radioembolization (RE) of primary and secondary malignancies of the liver.

RE has been established as a standard of care treatment for both primary and secondary cancers of the liver. The treatment consists of a mapping, or planning angiogram, followed by a delivery angiogram where the dose of yttrium 90 (y90) is delivered. Data has been published on the immune modification powers of external beam radiation (XRT). However, very little data is available on the ways in which RE modifies the immune system. The goal of this study is to determine changes in the peripheral blood monocytes, cytokines and the treated and untreated liver tumors through sample collection prior to and for 12 weeks after standard of care RE.

The prior to, the RE delivery procedure patients will have a blood draw to evaluate for levels of 11 immunologically relevant cytokines (IL-1α, IL-1β, IL-2, IL-6, IL-10, IL-12p70, IL-18, TNFα, IFN-ϒ, Fit ligand 3, and MCP-1). These blood draws will be repeated at 7 days (- 2 days, + 5 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.

The patients will also have the infiltration of immune relative cells into treated tumors evaluated. This will be done by the patients undergoing biopsy of the largest tumor to be treated prior to treatment and at 2 weeks (±7 days) following RE. If patients have other areas of tumor, which are not included in the initial treatment site, these areas will also be biopsied.

Finally, the change in immunologically important peripheral lymphocytes will be collected. This will be done with a blood draw on the day of, but prior to RE serving as an internal control. Patients will then also have blood draws performed at 7 days (±2 days), 4 weeks (± 2 weeks) and 12 weeks (± 2 weeks) after RE.

Conditions

Hepatocellular Carcinoma; Secondary Malignant Neoplasm of Liver

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Yttrium-90

This single arm study is to evaluate immunologic changes following the treatment of primary or secondary malignancies of the liver utilizing beta-emitting, Yttrium-90.

Group Type: OTHER

Yttrium-90

Intervention Type: OTHER

This is to evaluate the immunologic effects of yttrium 90.

Interventions

Yttrium-90

This is to evaluate the immunologic effects of yttrium 90.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Biopsy or image (in the setting of hepatocellular carcinoma (HCC)) diagnosed hepatic malignancy
• Total bilirubin < 2 mg/dL
• ECOG status ≤ 2
• Life expectancy >3 months as documented in the medical record by the enrolling physician
• Age >22 years
• Lesion >2.0 cm which is amenable to percutaneously biopsied

Exclusion Criteria

• Unwilling or unable to attend all study related follow ups
• Technetium 99 macro aggregated albumin (MAA) lung shunt fraction >20%
• Arterial anatomy which precludes the ability to safely perform RE
• INR > 1.8 or platelet count <50,000 which cannot be corrected
• Patients who are unable to hold anticoagulation and/or antiplatelet therapy in the periprocedural setting

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Shamar J Young, Young

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University of Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2018LS026

Identifier Type: -

Identifier Source: org_study_id