Patterns and Prevalence of FDG Extravasation in PET/CT Scans

Study Overview
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Brief Summary
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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.

Detailed Description
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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. In oncology, whole-body PET/CT is typically performed from the head to the pelvic floor (eyes to thighs). The use of the term whole-body is misleading because the most commonly used field of view (FOV) for arms-up whole-body PET/CT protocols includes only the base of skull to the upper thighs and does not include the brain, skull, and large portions of both upper and lower extremities. In such FOV, the most commonly used site of injection, namely the antecubital fossa (inside of the elbow), is frequently not included in the imaging field. In the Frontiers in Oncology article, Osman also determined that based on the commonly used FOV at most PET/CT centers, that when infiltration is present, it may be unnoticed by clinicians in approximately 31% of the cases. Lucerno Dynamics, a privately held company in North Carolina, has also discovered that the static image may be incapable of reporting on the quality of FDG administration during the  60 minute uptake period. Lucerno's system has been used in two investigational studies at two centers. At one center, the system was used with 8 patients for a total of 15 scans. At the other center, the system was used with 40 patients for a total of 85 scans. Similar rates of infiltrations were found to those described in the published articles. Based on this experience, Lucerno has found that infiltrations can partially resolve during the uptake period, so that even if they are visible in the PET image, the image may not reveal the extent of the infiltration. This could severely and negatively impact research and therapy decisions and thus patient outcomes. The Lucerno devices (Lucerno ID) are nonsignificant risk devices that add only 2-3 minutes to the current standard of care PET/CT scanning process. Lucerno ID sensors are applied to the patient's skin before the injection of the radiotracer and are removed after the FDG uptake period and prior to the PET/CT imaging process. The Lucerno ID has the ability to identify infiltrations, whether they are within or outside the FOV of reviewing clinicians, and can alert clinicians before their patient undergoes a compromised PET/CT scan due to the infiltration. This technology can prevent patients from receiving the additional CT radiation exposure of a compromised scan, can save cost, and can improve patient outcomes by ensuring more accurate PET scan interpretation.

Official Title
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Patterns and Prevalence of 18F-2-fluoro-2-deoxy-D-glucose (FDG) Extravasation in Positron Emission Tomography (PET)/ Computed Tomography (CT) Scans

Conditions
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Intravenous Infiltration

Intervention / Treatment
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* Device: Lucerno ID (identification) System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female patients ages 18-90. 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All participants are included in the static imaging arm. Some participants were also included in the dynamic imaging arm
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Static Imaging participants<br>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. | Device: Lucerno ID (identification) System<br>* The Lucerno ID is intended to dynamically measure the uptake of radiotracer in a particular organ or body region during the radiotracer uptake period as part of nuclear medicine (NM) procedures. The Lucerno ID is indicated for use as a tool for trained healthcare professionals (technologists, NM physicians, and radiologists) to help assess whether a radiotracer injection has resulted in an infiltration. The LD ID can be used by healthcare professionals including nuclear medical technologists, nuclear medicine physicians, or any other medical staff in a NM facility, once they have received the necessary training into the use of the system.<br>* Other names: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara;|
| Experimental: Dynamic image participants<br>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. | Device: Lucerno ID (identification) System<br>* The Lucerno ID is intended to dynamically measure the uptake of radiotracer in a particular organ or body region during the radiotracer uptake period as part of nuclear medicine (NM) procedures. The Lucerno ID is indicated for use as a tool for trained healthcare professionals (technologists, NM physicians, and radiologists) to help assess whether a radiotracer injection has resulted in an infiltration. The LD ID can be used by healthcare professionals including nuclear medical technologists, nuclear medicine physicians, or any other medical staff in a NM facility, once they have received the necessary training into the use of the system.<br>* Other names: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians | 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. | The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration | Review collected Lucerno sensor graphical data. The Lucerno time activity curves will capture an amount of activity from the sensors and assess subjects for presence or absence of infiltration at injection site. | 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 percentage of participants with infiltrations identified by physicians compared with those identified by the Lucerno sensor device as a measure of agreement between the two methods. | The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PET, infiltration, extravasation, PET/CT, PET-CT