Patterns and Prevalence of FDG Extravasation in PET/CT Scans

NCT03041090 | Completed Results FDA Device

• 1 other identifier: SLU IRB # 26741
• Study Type: interventional
• Target: 133
• Locations: 1 country
• Sites: 1

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.

Conditions

Intravenous Infiltration

Keywords

infiltration; extravasation; PET/CT; PET; PET-CT

Outcome Measures

Primary Outcomes (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.

  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)

• Number of Participants With Lucerno Sensor Device Detected Presence and/or Absence of Intravenous Infiltration

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

• Percentage of Participants With Infiltrations Identified by Physicians and Sensor Device

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

Study Arms (2)

Static Imaging participants

EXPERIMENTAL

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

Dynamic image participants

EXPERIMENTAL

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

Interventions

Lucerno ID (identification) System DEVICE

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.

Also known as: LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara

Dynamic image participants; Static Imaging participants

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Louis University: lead
• Lucerno Dynamics Limited Liability Company (LLC): collaborator

Study Sites (1)

SSM Saint Louis University Hospital

St Louis, Missouri, 63104, United States

Location

Related Publications (3)

• 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.

  PMID: 29127247 RESULT

• 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.

  PMID: 29042469 RESULT

• 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.

  PMID: 30443549 DERIVED

Related Links

• Published article: Novel Method to Detect and Characterize 18Fluoride-FDG Infiltration at the Injection Site: A Single-Institution Experience
• Published article: The Importance of Quality Control for Clinical PET Imaging

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Limitations and Caveats

Limitations: How the reading physicians visually assessed the radioactivity presence at the injection site may not consistently compare to the quantitative TACs. The motion of the patient during sensor measurement may affect measurements.

Results Point of Contact

• Title: Medhat Osman, MD, PhD - Professor of Radiology, Director of Nuclear Medicine and PET/CT
• Organization: Saint Louis University

medhat.osman@health.slu.edu

314-577-8047

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology; Director of Nuclear Medicine & PET/CT

Model Details: All participants are included in the static imaging arm. Some participants were also included in the dynamic imaging arm

Study Record Dates

• First Submitted: April 7, 2016
• First Posted: February 2, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)