Follow-up Yttrium-90 Internal Pair Production PET/CT Imaging in Patients With Primary or Metastatic Liver Tumors as Compared With Brehmsstrahlung Imaging: A Prospective Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.
研究概览
简要总结
This is a prospective non-blinded case series involving the acquisition of a pair production PET/CT as soon as possible after an already performed Y-90 Sirspheres treatment of hepatic malignancy. It will be performed in addition to the standard Brehmsstrahlung SPECT scan. The sequence of the two scans in each case (PET/CT vs SPECT) will be determined by availability of the scanners at the time. However, it is intended that both be acquired on the day of the Y-90 treatment.
The length of subject participation will be one year.
The measures used will be mostly qualitative in nature, and will include:
- Correlation with expected vs. achieved tumor coverage by the treatment
- Correlation between treatment distribution depicted by Brehmsstrahlung scans vs. the Internal Pair Production PET/CT scans, to.
- Detection of non-target embolization, where applicable, and qualitative comparison between the two modalities as to the conspicuity of the abnormality
Qualitative methods will be used by the analysis of the obtained PET/CT images and comparing them to the Brehmsstrahlung SPECT images as previously described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 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
- •Recipient of Selective Internal Radiation Treatment within 5 days.
- •Anticipated ability to remain still for up to 40 minutes
排除标准
- •Anticipated Inability to lie still for up to 40 minutes
- •Severe claustrophobia
- •Significant cardiovascular instability, or instability of other medical/surgical conditions, such that it would be deemed unsafe or technically not feasible to obtain a PET/CT, as determined by the any member of the investigative team
- •Failed deployment of the planned Y-90 treatment for any reason
- •Duration of time longer than 5 days since administration of the Y-90 treatment
- •Known pregnancy
研究组 & 干预措施
Y90 Based PET/CT Scan
干预措施: PET/CT Scan (Device)
结局指标
主要结局
Number of Subjects Whose Y-90 Based PET/CT (Positron Emission Tomography/Computed Tomography)Scans Detected Extrahepatic Non-target Embolization.
时间窗: 12 months
Number of participants with detected extrahepatic non-target embolization. A qualitative comparison between the two modalities (Y-90 PET/CT and Brehmsstrahlung SPECT) as to the conspicuity of the abnormality would have been conducted had any participant had that result.
次要结局
- Comparison Between Treatment Distribution Depicted by Tc99mMAA (Technetium-99m Macroaggregated Albumin) Brehmsstrahlung Scans vs. the Internal Pair Production PET/CT Scans.(12 months)
- Comparison of Y-90 PET/CT to Y90 SPECT(12 Months)
研究者
Jason Salsamendi
Associate Professor of Clinical
University of Miami