Clinical trial · Interventional
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System
Radioembolization of Primary and Secondary Liver Malignancies and The Effect On The Immune System: A Prospective Study of Cytokine Modulation And Immune Cell Infiltration
NCT03889093CI-TRIAL-00087582terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): PI Left Institution
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Secondary Malignant Neoplasm of Liver | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Yttrium-90 | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Yttrium-90
- description
- 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.
- interventionNames
- Other: Yttrium-90
Primary outcomes (1)
- measure
- Change in concentrations of PBMC
- timeFrame
- 12 weeks
- description
- 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 outcomes (3)
- measure
- Change in concentrations of cytokines
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.