Patterns and Prevalence of FDG Extravasation in PET/CT Scans
Condition: Intravenous Infiltration
Study type: Interventional

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.
    

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.
    

Intervention name(s): Lucerno ID (identification) System
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): LD ID (Lucerno Device identification), LD1 (Lucerno Device 1), Lucerno, Lara
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
Keywords: infiltration; extravasation; PET/CT; PET; PET-CT