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

NCT03889093 | Terminated

• 1 other identifier: 2018LS026
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; Secondary Malignant Neoplasm of Liver

Keywords

peripheral blood monocytes; cytokine

Outcome Measures

Primary Outcomes (1)

• Change in concentrations of PBMC

  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.

  12 weeks

Secondary Outcomes (3)

• Change in concentrations of cytokines

  1, 4, 12 weeks

• Change in concentrations of immune cell infiltration into the tumor

  1, 4, 12 weeks

• Change in concentrations of PBMC

  1 and 4 weeks

Study Arms (1)

Yttrium-90

OTHER

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

Interventions

Yttrium-90 OTHER

This is to evaluate the immunologic effects of yttrium 90.

Yttrium-90

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead

Study Sites (1)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Yttrium-90

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Shamar J Young, Young

  University of Minnesota

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single arm prospective study

Study Record Dates

• First Submitted: March 12, 2019
• First Posted: March 26, 2019
• Study Start: August 9, 2018
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

US (1)