The Lucerno Solution
The Lara® System
The Lucerno Lara System is currently listed with the FDA and uses sensors on the patient’s skin to detect the radiation emitted from the areas of interest beneath the sensors.
Prior to the administration, sensors are placed on the patient’s arms, using atraumatic adhesive pads. One sensor captures activity from the radiotracer at the administration site and the second sensor from the other arm, which acts as a control. Lara provides a real-time display of administration quality and after a portion of the uptake period, the sensors can be removed and recorded data uploaded to the Lucerno Web Application, Ellexa®. Within seconds, a time-activity curve is generated.
Since Lara sensors record the relative level of radiotracer in the areas of interest during and after the administration, Lara provides clinicians with evidence of the presence of radiotracer in the administration area during the uptake process. This information helps clinicians evaluate the quality of the administration process to determine if an extravasation has occurred. With this information, clinicians can characterize the absorbed dose delivered to the patient’s arm tissue and can assess the level of confidence regarding the therapy delivery or images used in patient management decision making.
The system is agnostic to imaging FOV, technologist experience, vein quality, or vascular access method.
Lara is easy to use, requires no additional radiopharmaceutical, and adds only twenty seconds to the patient experience and one to two minutes to the technologist’s process. Lara provides the quality control needed to ensure nuclear medicine procedures have not been compromised by an extravasation.
Quality control of administrations is especially important for most nuclear medicine procedures.
The Lucerno graph below shows an ideal administration. Note that the injection arm sensor curve (black line) and the reference arm sensor curve (red line) reach equilibrium within seconds. All diagnostic nuclear medicine administrations time-activity curves should look like this one.
The black line in the time-activity curve (below left) indicates a dramatically high level of radioactivity detected by the injection arm sensor. The red line indicates the level of activity from the reference arm sensor. Review of the time-activity curve prior to the patient being imaged alerted the technologist to possible extravasation. The technologist included the administration site in the imaging FOV. This extravasation was confirmed to be significant by the director of the PET center after measuring the remaining activity near the administration site from the static images.
A static nuclear medicine image is not enough
From the time-activity curve below, it would appear that by the time of imaging the injection arm sensor and reference arm sensor outputs would be very similar. In this situation, the administration site would appear to look normal in the imaging, or at worst have some small trace of radiopharmaceutical. The static image would not accurately reflect the quality of the administration. By reviewing the time-activity curve, the physician would know that a patient did not receive the entire bolus injection as expected.
While not an extravasation, a prolonged venous stasis may affect the delivery of the radiopharmaceutical. A static image taken of the administration site can lead clinicians to believe the radiopharmaceutical was ideally administered, when in fact, a prolonged venous stasis may have delayed the actual delivery of the radiopharmaceutical. The Lara® System can alert clinicians to the fact that a radiopharmaceutical was not delivered as intended, even though the static image of the administration site suggests the radiopharmaceutical was administered ideally.
Dynamically acquired images (bottom row) taken at various times (blue arrows) during uptake, static image (upper right), and black TAC (top curve) from the injection arm sensor all reflect complete resolution of a prolonged venous stasis. The red TAC reflects uptake captured by the reference arm sensor on the non-injection arm during the uptake period. The blue TAC reflects liver uptake. Proximity to injection arm sensor and nature of the liver uptake played some role in injection arm sensor TAC interpretation. Patient was positioned on PET imaging table to ensure the administration site would be located near the caudal edge of the PET imaging bed. Red arrows on dynamic image acquisition frames and static image indicate approximate administration site (right antecubital fossa).
In the case below from a test-retest clinical study, the administration site was out of the imaging FOV, but the patient experienced a significant extravasation that was identified by Lara and confirmed when the patient returned five days later for re-scan. Note the quality of the images taken after the extravasated administration versus the images taken after an ideal administration. The principal investigator determined that the quantification of these metastatic lesions was understated between 30-70% due to the extravasation (patient and protocol preparations were consistent between imaging studies to minimize variation between procedures).
Lucerno can provide QA/QC for radiopharmaceutical* administrations
The Lara System by Lucerno Dynamics is intended to dynamically measure the presence of radiopharmaceutical in an organ or body region during the uptake period as part of nuclear medicine procedures. The system is indicated for use with nuclear medicine patients. The system is indicated for use as a quality control tool to help assess whether a radiopharmaceutical remains near the administration site rather than circulating in the vascular system. The system is also indicated for use as a quality assurance tool to monitor, evaluate and help improve the radiopharmaceutical administration process. Additionally, the system is indicated for use to help evaluate the biological clearance of a radiopharmaceutical.
By using Lara with Lucerno’s proprietary Ellexa® software, centers can identify factors associated with extravasations, make appropriate adjustments, and improve quality. Through periodic reviews of these associated factors and process improvements, centers can improve patient safety, drive their overall extravasation rate down, and drive their quality indices up.
*Radiopharmaceuticals must include a gamma emission.