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

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ClinicalTrials.gov Identifier: NCT03889093
Recruitment Status : Recruiting
First Posted : March 26, 2019
Last Update Posted : October 25, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hepatocellular Carcinoma Secondary Malignant Neoplasm of Liver Other: Yttrium-90 Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm prospective study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System: A Prospective Study of Cytokine Modulation And Immune Cell Infiltration
Actual Study Start Date : August 9, 2018
Estimated Primary Completion Date : June 1, 2023
Estimated Study Completion Date : June 1, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Yttrium

Arms and Interventions
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Arm Intervention/treatment
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.
 Other: Yttrium-90
This is to evaluate the immunologic effects of yttrium 90.


Outcome Measures
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Primary Outcome Measures :
  1. Change in concentrations of PBMC [ Time Frame: 12 weeks ]
    Determine changes in the peripheral blood lymphocytes utilizing flow cytometery after radioembolization (RE) therapy for primary and secondary malignancies of the liver at 12 weeks.


Secondary Outcome Measures :
  1. Change in concentrations of cytokines [ Time Frame: 1, 4, 12 weeks ]
    Determine changes in the peripheral blood cytokines after radioembolization (RE) therapy for primary and secondary malignancies of the liver. Specifically cytokines IL-1α units/mg, IL-1β units/mg, IL-2 units/mg, IL-6 units/mg, IL-10 units/mg, IL-12p70 units/mg, IL-18 units/mg, TNFα units/mg, IFN-Y units/mg, Fit ligand 3 units/mg, and MCP-1 units/mg will be measured.

  2. Change in concentrations of immune cell infiltration into the tumor [ Time Frame: 1, 4, 12 weeks ]
    Determine the changes in infiltrating immune cells within the treated tumor, which occur after radioembolization (RE) therapy for primary and secondary malignancies of the liver. This will be accomplished by obtaining tissue samples of the treated tumor before and after treatment, then performing staining and cell counts to determine the change in cytotoxic t cells, t helper cells, natural kill cells, macrophages, and dendritic cells.

  3. Change in concentrations of PBMC [ Time Frame: 1 and 4 weeks ]
    Determine changes in the peripheral blood lymphocytes utilizing flow cytometery after radioembolization (RE) therapy for primary and secondary malignancies of the liver at 1 and 4 weeks.


Eligibility Criteria
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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03889093


Contacts
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Contact: Shamar J Young, MD 612-626-5566 youn1862@umn.edu

Locations
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United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Shamar J Young, MD    612-626-5566    youn1862@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Shamar J Young, Young University of Minnesota
More Information
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03889093    
Other Study ID Numbers: 2018LS026
First Posted: March 26, 2019    Key Record Dates
Last Update Posted: October 25, 2021
Last Verified: October 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Minnesota:
peripheral blood monocytes
cytokine
Additional relevant MeSH terms:
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Neoplasms
Neoplasm Metastasis
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Digestive System Diseases
Liver Diseases
Neoplastic Processes
Pathologic Processes