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Patterns and Prevalence of FDG Extravasation in PET/CT Scans (Lucerno device)

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ClinicalTrials.gov Identifier: NCT03041090
Recruitment Status : Completed
First Posted : February 2, 2017
Results First Posted : June 14, 2019
Last Update Posted : June 14, 2019
Sponsor:
Collaborator:
Lucerno Dynamics Limited Liability Company (LLC)
Information provided by (Responsible Party):
Medhat M. Osman, MD., Sc.M., Ph.D., St. Louis University

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.


Condition or disease Intervention/treatment Phase
Intravenous Infiltration Device: Lucerno ID (identification) System Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 133 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Diagnostic
Official Title: Patterns and Prevalence of 18F-2-fluoro-2-deoxy-D-glucose (FDG) Extravasation in Positron Emission Tomography (PET)/ Computed Tomography (CT) Scans
Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Static Imaging participants

This 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.

Device: Lucerno ID (identification) System
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.
Other Name: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara

Experimental: Dynamic image participants

This 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.

Device: Lucerno ID (identification) System
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.
Other Name: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara




Primary Outcome Measures :
  1. 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. ]
    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 Outcome Measures :
  1. Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration [ 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. ]
    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.

  2. Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device [ 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. ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03041090


Locations
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United States, Missouri
SSM Saint Louis University Hospital
Saint Louis, Missouri, United States, 63104
Sponsors and Collaborators
St. Louis University
Lucerno Dynamics Limited Liability Company (LLC)
  Study Documents (Full-Text)

Documents provided by Medhat M. Osman, MD., Sc.M., Ph.D., St. Louis University:
Informed Consent Form  [PDF] January 30, 2017
Study Protocol  [PDF] February 14, 2017
No Statistical Analysis Plan (SAP) exists for this study.

Additional Information:
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medhat M. Osman, MD., Sc.M., Ph.D., Professor of Radiology; Director of Nuclear Medicine & PET/CT, St. Louis University
ClinicalTrials.gov Identifier: NCT03041090    
Other Study ID Numbers: SLU IRB # 26741
First Posted: February 2, 2017    Key Record Dates
Results First Posted: June 14, 2019
Last Update Posted: June 14, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Coded data will be shared with our industry sponsor, Lucerno Dynamics

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Medhat M. Osman, MD., Sc.M., Ph.D., St. Louis University:
infiltration
extravasation
PET/CT
PET
PET-CT