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NCT03041090 · ClinicalTrials.gov registry record · NA
Patterns and Prevalence of FDG Extravasation in PET/CT Scans
A NA study of Intravenous Infiltration, sponsored by St. Louis University.
- Completed
- Registry status
- NA
- Development phase
- 133
- Enrollment target
- 1
- Study location
NCT03041090: Completed NA study of Intravenous Infiltration, sponsored by St. Louis University.
NCT03041090 is a NA study of Intravenous Infiltration that has completed, run by St. Louis University. The registered enrollment target is 133 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03041090, a NA study of Intravenous Infiltration, has completed, sponsored by St. Louis University.
- COMPLETED
- Registry status
- NA
- Development phase
- 133 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE Lucerno ID (identification) System
Study Locations (1)
Missouri
- SSM Saint Louis University Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 133 participants |
| Start Date | 2016-03 |
| Est. Completion | 2017-12 |
| Phase | NA |
What the finished NCT03041090 record still lists
NCT03041090 is an interventional study that assigns participants to a tested intervention. The registered 133 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Intravenous Infiltration appearing as the primary indexed condition, and to 1 intervention - of which Lucerno ID (identification) System is the first listed.
NCT03041090 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT03041090 about?
NCT03041090 is a clinical study titled "Patterns and Prevalence of FDG Extravasation in PET/CT Scans". 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 ...
What is the current status of trial NCT03041090?
This trial is currently completed. It is a NA study. The enrollment target is 133 participants. The study started on 2016-03. Estimated completion is 2017-12.
What conditions does trial NCT03041090 study?
This clinical trial studies the following conditions: Intravenous Infiltration.
What interventions are being tested in trial NCT03041090?
The interventions under investigation include: Lucerno ID (identification) System (DEVICE).
Who is sponsoring clinical trial NCT03041090?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03041090 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03041090's enrollment target sits among peer trials
133 729th of 2000 higher than 1,272 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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