Trial Outcomes & Findings for Patterns and Prevalence of FDG Extravasation in PET/CT Scans (NCT NCT03041090)
NCT ID: NCT03041090
Last Updated: 2019-06-14
Results Overview
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.
COMPLETED
NA
133 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.
2019-06-14
Participant Flow
Participant milestones
| Measure |
Static Imaging Participants
This arm of the study assessed participants' static Positron Emission Tomography / Computed Tomography (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. This arm also visually assessed the images at the injection site by a board certified physician.
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Dynamic Image Participants
This arm of the study assessed participants' dynamic Positron Emission Tomography / Computed Tomography (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. This arm also visually assessed the images at the injection site by a board certified physician.
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|---|---|---|
|
Overall Study
STARTED
|
109
|
24
|
|
Overall Study
COMPLETED
|
109
|
21
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
Reasons for withdrawal
| Measure |
Static Imaging Participants
This arm of the study assessed participants' static Positron Emission Tomography / Computed Tomography (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. This arm also visually assessed the images at the injection site by a board certified physician.
|
Dynamic Image Participants
This arm of the study assessed participants' dynamic Positron Emission Tomography / Computed Tomography (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. This arm also visually assessed the images at the injection site by a board certified physician.
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|---|---|---|
|
Overall Study
technical error
|
0
|
3
|
Baseline Characteristics
Participant age was not included in analysis. The inclusion/exclusion criteria included that the subjects must be greater than or equal to 18 years and less than or equal to 90 years. Once the age was verified during the consent process, the specific age of the subject was not included in analysis.
Baseline characteristics by cohort
| Measure |
Dynamic Arm
n=24 Participants
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.
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Static Arm
n=109 Participants
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.
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Total
n=133 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Customized
Age
|
0 Participants
Participant age was not included in analysis. The inclusion/exclusion criteria included that the subjects must be greater than or equal to 18 years and less than or equal to 90 years. Once the age was verified during the consent process, the specific age of the subject was not included in analysis.
|
0 Participants
Participant age was not included in analysis. The inclusion/exclusion criteria included that the subjects must be greater than or equal to 18 years and less than or equal to 90 years. Once the age was verified during the consent process, the specific age of the subject was not included in analysis.
|
0 Participants
Participant age was not included in analysis. The inclusion/exclusion criteria included that the subjects must be greater than or equal to 18 years and less than or equal to 90 years. Once the age was verified during the consent process, the specific age of the subject was not included in analysis.
|
|
Sex/Gender, Customized
Gender
|
0 Participants
Participant gender was not included in analysis. Al genders were included in the inclusion/exclusion criteria, so this data was not recorded nor included in analysis.
|
0 Participants
Participant gender was not included in analysis. Al genders were included in the inclusion/exclusion criteria, so this data was not recorded nor included in analysis.
|
0 Participants
Participant gender was not included in analysis. Al genders were included in the inclusion/exclusion criteria, so this data was not recorded nor included in analysis.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
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Region of Enrollment
United States
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24 Participants
n=24 Participants
|
109 Participants
n=109 Participants
|
133 Participants
n=133 Participants
|
|
Scheduled for a standard of care PET/CT
|
24 Participants
n=24 Participants
|
109 Participants
n=109 Participants
|
133 Participants
n=133 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Dynamic Arm
n=21 Participants
This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.
|
Static Arm
n=109 Participants
This arm includes the study participants that participated in static image acquisition.
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|---|---|---|
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Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians
|
17 Participants
|
32 Participants
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Dynamic Arm
n=21 Participants
This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.
|
Static Arm
n=109 Participants
This arm includes the study participants that participated in static image acquisition.
|
|---|---|---|
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Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration
|
14 Participants
|
26 Participants
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Dynamic Arm
n=21 Participants
This arm includes the study participants that participated in dynamic image acquisition. Dynamic images include multiple static images over a specified amount of time per image.
|
Static Arm
n=109 Participants
This arm includes the study participants that participated in static image acquisition.
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|---|---|---|
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Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device
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66.67 percentage of participants
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23.85 percentage of participants
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Adverse Events
Dynamic Arm
Static Arm
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Medhat Osman, MD, PhD - Professor of Radiology, Director of Nuclear Medicine and PET/CT
Saint Louis University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place