Immunologic Effects of Radioembolization of Primary and Secondary Liver Malignancies
| Status: | Recruiting |
|---|---|
| Conditions: | Liver Cancer, Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - Any |
| Updated: | 3/28/2019 |
| Start Date: | August 9, 2018 |
| End Date: | June 1, 2021 |
| Contact: | Shamar J Young, MD |
| Email: | youn1862@umn.edu |
| Phone: | 612-626-5566 |
Radioembolization of Primary and Secondary Liver Malignancies
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.
immune system. This will be done by evaluating the changes on biopsy, peripheral blood
monocytes, and cytokines.
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.
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.
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
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