N/A
N=133
Patterns and Prevalence of FDG Extravasation in PET/CT Scans
Intravenous Infiltration
Bottom Line
View on ClinicalTrials.gov: NCT03041090 ↗Enrolled (actual)
133
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcome: Primary: Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians — 17; 32 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lucerno ID (identification) System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians |
17; 32 | — |
| SECONDARY Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration |
14; 26 | — |
| SECONDARY Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device |
66.67; 23.85 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03041090). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.