Towards real-time topical detection and characterization of FDG dose infiltration prior to PET imaging.

PURPOSE: To dynamically detect and characterize 18F-fluorodeoxyglucose (FDG) dose infiltrations and evaluate their effects on positron emission tomography (PET) standardized uptake values (SUV) at the injection site and in control tissue. METHODS: Investigational gamma scintillation sensors were topically applied to patients with locally advanced breast cancer scheduled to undergo limited whole-body FDG-PET as part of an ongoing clinical study. Relative to the affected breast, sensors were placed on the contralateral injection arm and ipsilateral control arm during the resting uptake phase prior to each patient's PET scan. Time-activity curves (TACs) from the sensors were integrated at varying intervals (0-10, 0-20, 0-30, 0-40, and 30-40 min) post-FDG and the resulting areas under the curve (AUCs) were compared to SUVs obtained from PET. RESULTS: In cases of infiltration, observed in three sensor recordings (30 %), the injection arm TAC shape varied depending on the extent and severity of infiltration. In two of these cases, TAC characteristics suggested the infiltration was partially resolving prior to image acquisition, although it was still apparent on subsequent PET. Areas under the TAC 0-10 and 0-20 min post-FDG were significantly different in infiltrated versus non-infiltrated cases (Mann-Whitney, p < 0.05). When normalized to control, all TAC integration intervals from the injection arm were significantly correlated with SUVpeak and SUVmax measured over the infiltration site (Spearman ρ ≥ 0.77, p < 0.05). Receiver operating characteristic (ROC) analyses, testing the ability of the first 10 min of post-FDG sensor data to predict infiltration visibility on the ensuing PET, yielded an area under the ROC curve of 0.92. CONCLUSIONS: Topical sensors applied near the injection site provide dynamic information from the time of FDG administration through the uptake period and may be useful in detecting infiltrations regardless of PET image field of view. This dynamic information may also complement the static PET image to better characterize the true extent of infiltrations.

Assessing and Reducing Positron Emission Tomography/Computed Tomography Radiotracer Infiltrations: Lessons in Quality Improvement and Sustainability.

PURPOSE: Accurate administration of radiotracer dose is essential to positron emission tomography (PET) image quality and quantification. Misadministration (infiltration) of the dose can affect PET/computed tomography results and lead to unnecessary or inappropriate treatments and procedures. Quality control efforts ensure accuracy of the administered dose; however, they fail to ensure complete delivery of the dose into the patient's circulation. We used new technology to assess and improve infiltration rates and evaluate sustainability. METHODS: Injection quality was measured, improved, and sustained during our participation in a multicenter quality improvement project using Define, Measure, Analyze, Improve, Control methodology. Five technologists monitored injection quality in the Measure and Improve phases. After seven new technologists joined the team in the Control phase, infiltration rates were recalculated, controlling for technologist- and patient-level correlations, and comparisons were made between these two groups of technologists. RESULTS: In the Measure phase, five technologists monitored 263 injections (13.3% infiltration rate). Nonantecubital fossa injections had a higher probability of infiltration than antecubital fossa injections. After implementing a quality improvement plan (QIP), the same technologists monitored 278 injections in the Improve phase (2.9% infiltration rate). The 78% decrease in infiltration rate was significant (P < .001) as was the decrease in nonantecubital fossa infiltrations (P = .0025). In the Control phase, 12 technologists monitored 1,240 injections (3.1% infiltration rate). The seven new technologists had significantly higher rates of infiltration (P = .017). CONCLUSION: A QIP can significantly improve and sustain injection quality; however, ongoing monitoring is needed as new technologists join the team.

Quality Improvement Initiatives to Assess and Improve PET/CT Injection Infiltration Rates at Multiple Centers.

PET/CT radiotracer infiltration is not uncommon and is often outside the imaging field of view. Infiltration can negatively affect image quality, image quantification, and patient management. Until recently, there has not been a simple way to routinely practice PET radiopharmaceutical administration quality control and quality assurance. Our objectives were to quantify infiltration rates, determine associative factors for infiltration, and assess whether rates could be reduced at multiple centers and then sustained. Methods: A "design, measure, analyze, improve, and control" quality improvement methodology requiring novel technology was used to try to improve PET/CT injection quality. Teams were educated on the importance of quality injections. Baseline infiltration rates were measured, center-specific associative factors were analyzed, team meetings were held, improvement plans were established and executed, and rates remeasured. To ensure that injection-quality gains were retained, real-time feedback and ongoing monitoring were used. Sustainability was assessed. Results: Seven centers and 56 technologists provided data on 5,541 injections. The centers' aggregated baseline infiltration rate was 6.2% (range, 2%-16%). On the basis of their specific associative factors, 4 centers developed improvement plans and reduced their aggregated infiltration rate from 8.9% to 4.6% (P < 0.0001). Ongoing injection monitoring showed sustainability. Significant variation was found in center- and technologist-level infiltration rates (P < 0.0001 and P = 0.0020, respectively). Conclusion: A quality improvement approach with new technology can help centers measure infiltration rates, determine associative factors, implement interventions, and improve and sustain injection quality. Because PET/CT images help guide patient management, the monitoring and improvement of radiotracer injection quality are important.

Impact of an 18F-FDG PET/CT Radiotracer Injection Infiltration on Patient Management-A Case Report.

Major management decisions in patients with solid tumors and lymphomas are often based on 18F-fluorodeoxyglucose (18F-FDG) PET/CT. The misadministration of 18F-FDG outside the systemic circulation can have an adverse impact on this test's sensitivity (1) and is not uncommon (2-7). This report describes how an 18F-FDG misadministration led to a repeat PET/CT study, resulting in the visualization of distant metastases that changed the original treatment plan. The findings suggest that routine injection monitoring is indicated whenever sensitivity is critical, and support claims that infiltrations can confound interpretation of semi-quantitative PET outcome measures in patients who are followed longitudinally (2).

Usefulness of Topically Applied Sensors to Assess the Quality of 18F-FDG Injections and Validation Against Dynamic Positron Emission Tomography (PET) Images.

Background: Infiltrations of 18F-fluorodeoxyglucose (FDG) injections affect positron emission tomography/computed tomography (PET/CT) image quality and quantification. A device using scintillation sensors (Lucerno Dynamics, Cary, NC) provides dynamic measurements acquired during FDG uptake to identify and characterize radioactivity near the injection site prior to patient imaging. Our aim was to compare sensor measurements against dynamic PET image acquisition, our proposed reference in assessing injection quality during the uptake period. Methods: Subjects undergoing routine FDG PET/CT imaging were eligible for this Institutional Review Board approved prospective study. After providing informed consent, subjects had sensors topically placed on their arms. FDG was injected into subjects' veins directly on the PET imaging table. Dynamic images of the injection site were acquired during 45 min of the uptake period. These dynamic image acquisitions and subjects' routine standard static images were evaluated by nuclear medicine physicians for abnormal FDG accumulation near the injection site. Sensor measurements were interpreted independently by Lucerno staff. Dynamic image acquisition interpretation results were compared to the sensor measurement interpretations and to static image interpretations. Results: Twenty-four subjects were consented and enrolled. Data from 21 subjects were gathered. During dynamic image acquisition review, physicians interpreted 4 subjects with no FDG accumulation at the injection site, whereas 17 showed evidence of accumulation. In 10 of the 17 cases that showed FDG accumulation, the FDG presence at the injection site resolved completely during uptake corresponding to venous stasis, the temporary sequestration of blood from circulation. Static image interpretation agreed with dynamic images interpretation in 11/21 (52%) subjects. Sensor measurement interpretations agreed with the dynamic images interpretations in 18/21 (86%) subjects. Conclusions: Sensor measurements can be an effective way to identify and characterize infiltrations and venous stasis. Comparable to an infiltration, venous stasis may produce spurious and clinically meaningful measurement bias and possibly even scan misinterpretation. Since the quality and quantification of PET/CT studies are of clinical importance, sensor measurements acquired during the FDG uptake may prove to be a useful quality control measure to reduce infiltration rates and potentially improve patient care. Registration: Clinicaltrials.gov, Identifier: NCT03041090.