Intravenous Infiltration
Conditions
Keywords
infiltration, extravasation, PET/CT, PET, PET-CT
Brief summary
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
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.
Interventions
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.
Sponsors
Study design
Intervention model description
All participants are included in the static imaging arm. Some participants were also included in the dynamic imaging arm
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dynamic Arm Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. During the 60 minute uptake, these subjects were scanned. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. Dynamic arm (n=24 where 21 were analyzed) had 3 subjects that could not be analyzed due to technical errors, so 21 subjects were analyzed from this arm. Age and gender were not considered confounding factors and were not collected as part of the clinical study. | 24 |
| Static Arm Participants that were already scheduled for a standard of care PET/CT study at a single institution could be included in this study. Those that chose to consent for this study had device sensors placed on the skin in four separate locations. The sensors could detect radiotracer near the injection site that was unavailable for circulation. After the 60 minute uptake period, the sensors were removed and participants continued with the normal PET/CT procedure. Participants also completed a questionnaire about the detector comfort. The static arm included 109 subjects. Age and gender were not considered confounding factors and were not collected as part of the clinical study. | 109 |
| Total | 133 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | technical error | 0 | 3 |
Baseline characteristics
| Characteristic | Dynamic Arm | Static Arm | Total |
|---|---|---|---|
| Age, Customized Age | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment United States | 24 Participants | 109 Participants | 133 Participants |
| Scheduled for a standard of care PET/CT | 24 Participants | 109 Participants | 133 Participants |
| Sex/Gender, Customized Gender | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 109 |
| other Total, other adverse events | 0 / 24 | 0 / 109 |
| serious Total, serious adverse events | 0 / 24 | 0 / 109 |
Outcome results
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.
Time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dynamic Arm | Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians | 17 Participants |
| Static Arm | Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians | 32 Participants |
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.
Time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
Population: The Time Activity Curve was studied that was provided from the sensor device among patients who underwent dynamic and static imaging.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dynamic Arm | Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration | 14 Participants |
| Static Arm | Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration | 26 Participants |
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.
Time frame: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dynamic Arm | Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device | 66.67 percentage of participants |
| Static Arm | Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device | 23.85 percentage of participants |