Yttrium Y-90 Radioembolization in Treating Patients With Metastatic Liver Cancer

Study Overview
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Brief Summary
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This clinical trial studies the side effects and best way to perform yttrium Y-90 radioembolization in treating patients with liver cancer that has spread to other places in the body (metastatic). Yttrium Y-90 radioembolization is a therapy that injects radioactive microspheres directly into an artery that feeds liver tumors to cut off their blood supply. Performing yttrium Y-90 radioembolization in a single session may make treatment faster, minimize patient travel, and decrease the overall cost of the procedure.

Detailed Description
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PRIMARY OBJECTIVE: I. To evaluate the feasibility and safety of same day yttrium-90 radioembolization planning and treatment angiography. SECONDARY OBJECTIVES: I. To determine the patient costs associated with same diagnostic and treatment compared when compared to the standard two session methodology. II. To determine the time required to perform the mandatory in-room technetium Tc-99m albumin aggregated (99mTc-MAA) imaging and the associated calculations for the lung shunt fraction and treatment 90Y-microsphere activity. III. To determine the time for delivery of the therapy 90Y-microsphere radioactivity to the angiography suite after the therapy written directive by the authorized user. OUTLINE: The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. After completion of study treatment, patients are followed up at 1, 3, and 6 months.

Official Title
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Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment

Conditions
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Stage IVB Liver Cancer, Metastatic Liver Carcinoma, Stage IV Liver Cancer, Stage IVA Liver Cancer

Intervention / Treatment
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* Procedure: Angiography
* Procedure: Computed Tomography
* Procedure: Planar Imaging
* Radiation: Radioembolization
* Procedure: Single Photon Emission Computed Tomography
* Radiation: Technetium Tc-99m Albumin Aggregated
* Other: Yttrium Y 90 Resin Microspheres


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The ability to understand and sign informed consent Any candidate eligible for standard of care Y90 radioembolization for treatment of their primary or metastatic liver tumors Exclusion Criteria: Patients with greater than 50% liver tumor burden

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment (angiography, yttrium Y-90 radioembolization)<br>The first 2 patients enrolled receive standard of care diagnostic and treatment during 2 visits for approximately 6 hours each within 2-4 weeks. During the first visit, patients undergo diagnostic angiography with embolization of potential hepatoenteric collaterals, receive technetium Tc-99m albumin aggregated as a surrogate to the therapy microspheres via catheter, and undergo planar imaging. During the second visit, patients undergo a second angiography and receive yttrium Y 90 resin microspheres via arterial microcatheter. Patients then undergo single-photon emission computed tomography-computed tomography (SPECT-CT) Bremsstrahlung imaging. All subsequent patients enrolled undergo the same previously described diagnostic and treatment during 1 visit over about 8 hours. | Procedure: Angiography<br>* Undergo angiography<br>Procedure: Computed Tomography<br>* Undergo SPECT-CT<br>* Other names: tomography;Procedure: Planar Imaging<br>* Undergo planar imaging<br>Radiation: Radioembolization<br>* Undergo radioembolization<br>* Other names: intra-arterial brachytherapy;Procedure: Single Photon Emission Computed Tomography<br>* Undergo SPECT-CT<br>* Other names: Tomography, Emission-Computed, Single-Photon;Radiation: Technetium Tc-99m Albumin Aggregated<br>* Given via arterial catheter<br>* Other names: Technetium Tc-99m Albumin Colloid;Other: Yttrium Y 90 Resin Microspheres<br>* Given via arterial catheter<br>* Other names: SIR-Spheres;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of same day yttrium Y-90 radioembolization planning and treatment angiography | Success will be defined as treatment dose calculated and patient treated on the same day of initial radiation. Feasibility will be defined as at least 9 successful same day treatments. A procedure lasting greater than 4 hours will be considered a failure. The time associated with various aspects of the same-day yttrium Y-90 radioembolization procedure will be determined. Will determine the time and cost for the patient and for MD Anderson Cancer Center between the same day yttrium Y-90-radioembolization treatment and the current standard of care two-day treatment schedule. Success status will be summarized using frequencies and percentages. Success rate will be estimated along with exact 95% confidence interval. Patient characteristics will be summarized using appropriate summary statistics. | Up to 6 months | 
| Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0 | The summaries will be overall (severity grades 1 through 5). Actions taken for grade 3 events will also be reported. The summaries will present the number and percentage of patients reporting and adverse event for each classification level as well as the number events reported. Laboratory values will be summarized by the treatment group over time. | Up to 6 months |