Patterns and Prevalence of 18F-2-fluoro-2-deoxy-D-glucose (FDG) Extravasation in Positron Emission Tomography (PET)/ Computed Tomography (CT) Scans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 133
- 试验地点
- 2
- 主要终点
- Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians
研究概览
简要总结
PET (Positron Emission Tomography) images are used to help make patient management decisions in staging and treatment assessment, often after a cancer diagnosis.
Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is known as extravasation or infiltration, and it compromises the doctor's ability to read the PET image. Often, the site where the tracer is injected into the vein (usually in the inside of the elbow) are not in the images taken, so reading physicians are unaware that an extravasation or infiltration has occurred.
Technology exists to capture time activity curves (amount of tracer in a location over a period of time) during the PET tracer uptake period (usually once the tracer is injected, the tracer circulates for 60 minutes prior to images), which can enable physicians to accurately detect extravasations and infiltration. This information is currently unavailable to physicians reading routine PET/CT (computed tomography) scans.
Time activity curves information gathered from these sensors during the circulation period appear to match the brief pictures taken approximately 70 minutes after the tracer injection.
This study will determine if these time activity curves correspond to PET images of the injection site taken during the tracer uptake period. If time activity curves correspond to PET images, they can be used to determine if the tracer was properly injected. If there was an improper injection, clinicians can be alerted to this fact and interpret the image with this additional information.
详细描述
PET (Positron Emission Tomography) images are used to help make patient management decisions in staging and treatment assessment, often after a cancer diagnosis.
Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is known as extravasation or infiltration, and it compromises the doctor's ability to read the PET image. Often, the site where the tracer is injected into the vein (usually in the inside of the elbow) are not in the images taken, so reading physicians are unaware that an extravasation or infiltration has occurred.
Technology exists to capture time activity curves (amount of tracer in a location over a period of time) during the PET tracer uptake period (usually once the tracer is injected, the tracer circulates for 60 minutes prior to images), which can enable physicians to accurately detect extravasations. This information is currently unavailable to physicians reading routine PET/CT scans.
Time activity curves information gathered from these sensors during the circulation period appear to match the brief pictures taken approximately 70 minutes after the tracer injection.
This study will determine if these time activity curves correspond to PET images of the injection site taken during the tracer uptake period. If time activity curves correspond to PET images, they can be used to determine if the tracer was properly injected. If there was an improper injection, clinicians can be alerted to this fact and interpret the image with this additional information.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients ages 18-
- •Scheduled for a standard of care PET/CT scan at Sisters of Saint Mary (SSM) Saint Louis University (SLU) Hospital
- •Willing to have self-adhesive sensors placed on the injections site, contralateral arm in approximately the same position as the injection site, liver, and over the subclavical area.
- •If consenting to imaging during the PET/CT uptake period, the patient must be able to rest comfortably on the PET/CT scanning table for approximately 60 minutes during the circulation of the tracer for additional PET only imaging.
排除标准
- •Persons (male or female) under age 18
- •Persons with concerns about 4 adhesive sensors being placed on their bodies during the uptake period.
- •Subjects unwilling to sign the consent document.
- •Subjects who cannot consent for themselves
- •Subjects who are not scheduled for a standard of care PET/CT exam at SLU hospital
研究组 & 干预措施
Static Imaging participants
This arm of the study assessed participants' static PET/CT images. These were the standard of care images acquired after their standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.
Intervention was Lucerno sensors (Lucerno Device Identity Document (LD ID), Lucerno Device 1 (LD1), Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.
干预措施: Lucerno ID (identification) System (Device)
Dynamic image participants
This arm of the study assessed participants' dynamic PET/CT images. These were the study related images of and around the injection site acquired during the participants' standard of care uptake time. These images were assessed visually by a board certified physician and using the Time Activity Curves from the sensor data.
Intervention was Lucerno sensors (LD ID, LD1, Lucerno, Lara) placed on participant to monitor radiotracer activity at and around injection site.
干预措施: Lucerno ID (identification) System (Device)
结局指标
主要结局
Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians
时间窗: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
Infiltrations of 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) during Positron Emission Tomography (PET) radiotracer administration can lead to sub-optimal images. We aim to compare rates of radiotracer presence near the injection site detected by physicians. Every subject that participates in an FDG-PET scan received an intervenous injection as part of this study. The number of participants by arm were provided in Static Imaging Participants and Dynamic Imaging Participants.
次要结局
- Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration(The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.)
- Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device(The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.)
研究者
Medhat M. Osman, MD., Sc.M., Ph.D.
Professor of Radiology; Director of Nuclear Medicine & PET/CT
St. Louis University