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Intravenous InfiltrationLucerno deviceNCT03041090

Patterns and Prevalence of FDG Extravasation in PET/CT Scans

A study testing Lucerno ID (identification) System in people with Intravenous Infiltration, run by St. Louis University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Intravenous Infiltration
What is being tested?
Lucerno ID (identification) System
Could I receive a placebo?
No, everyone receives an active treatment
How many people
133 participants
Where
1 siteUnited States
Study dates
Mar 2016to Dec 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • SSM Saint Louis University Hospital

    St Louis, Missouri, 63104

Other trials in United States

About this study

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

Read more

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.

Read the 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.

Being tested
Lucerno ID (identification) System
Keywords
infiltration, extravasation, PET/CT, PET, PET-CT

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lucerno ID (identification) SystemDevice

    Also called LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara

    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.

Study groups in NCT03041090
Study groupRoleWhat they receive
Static Imaging participantsExperimentalThis 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.
Receives: Device: Lucerno ID (identification) System
Dynamic image participantsExperimentalThis 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.
Receives: Device: Lucerno ID (identification) System

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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 outcomes (2)
  1. 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.

    Measured: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.

  2. 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.

    Measured: The time frame would be from the time the sensors were placed to the time the sensors were removed; no more than 2 hours.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Feb 2017 (estimated)
  2. Study startMar 2016
  3. Primary completionDec 2017
  4. Study completionDec 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Non-randomised
Intervention model
Parallel groups
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)
Enrolment
133 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03041090
Sponsor's protocol ID
SLU IRB # 26741
Acronym
Lucerno device
Status last verified
Jun 2019
First submitted
7 Apr 2016
Last updated
14 Jun 2019
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
Yes: Coded data will be shared with our industry sponsor, Lucerno Dynamics

Publications

  • Muzaffar R, Frye SA, McMunn A, Ryan K, Lattanze R, Osman MM. Novel Method to Detect and Characterize 18F-FDG Infiltration at the Injection Site: A Single-Institution Experience. J Nucl Med Technol. 2017 Dec;45(4):267-271. doi: 10.2967/jnmt.117.198408. Epub 2017 Nov 10.

    PubMed 29127247
  • Schaefferkoetter JD, Osman M, Townsend DW. The Importance of Quality Control for Clinical PET Imaging. J Nucl Med Technol. 2017 Dec;45(4):265-266. doi: 10.2967/jnmt.117.198465. Epub 2017 Oct 17. No abstract available.

    PubMed 29042469
  • Lattanze RK, Osman MM, Ryan KA, Frye S, Townsend DW. Usefulness of Topically Applied Sensors to Assess the Quality of 18F-FDG Injections and Validation Against Dynamic Positron Emission Tomography (PET) Images. Front Med (Lausanne). 2018 Nov 1;5:303. doi: 10.3389/fmed.2018.00303. eCollection 2018.

    PubMed 30443549

Questions about this trial

What is this clinical trial studying?

A study testing Lucerno ID (identification) System in people with Intravenous Infiltration, run by St. Louis University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Intraveneous Infiltration of FDG During Routine PET/CT Imaging by Visually Assessment of Interpreting Physicians (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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03041090, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019; AzTrials last refreshed its copy on 7 Nov 2026.

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