Feasibility of Single Session In-Room Yttrium-90 Radioembolization Diagnostic Angiography and Treatment
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Patients with greater than 50% liver tumor burden
研究组 & 干预措施
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Angiography (Procedure)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Radioembolization (Radiation)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Single Photon Emission Computed Tomography (Procedure)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Computed Tomography (Procedure)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Planar Imaging (Procedure)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Technetium Tc-99m Albumin Aggregated (Radiation)
Treatment (angiography, yttrium Y-90 radioembolization)
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.
干预措施: Yttrium Y 90 Resin Microspheres (Other)
结局指标
主要结局
Incidence of adverse event assessed by National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0
时间窗: Up to 6 months
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.
Success of same day yttrium Y-90 radioembolization planning and treatment angiography
时间窗: Up to 6 months
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.
次要结局
未报告次要终点