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Introduction: A newly developed clinical organ-targeted Positron Emission Tomography (PET) system (also known as Radialis PET) is tested with a set of standardized and custom tests previously used to evaluate the performance of Positron Emission Mammography (PEM) systems. Methods: Imaging characteristics impacting standardized uptake value (SUV) and detectability of small lesions, namely spatial resolution, linearity, uniformity, and recovery coefficients, are evaluated. Results: In-plane spatial resolution was measured as 2.3 mm ± 0.1 mm, spatial accuracy was 0.1 mm, and uniformity measured with flood field and NEMA NU-4 phantom was 11.7% and 8.3% respectively. Selected clinical images are provided as reference to the imaging capabilities under different clinical conditions such as reduced activity of 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (18F-FDG) and time-delayed acquisitions. SUV measurements were performed for selected clinical acquisitions to demonstrate a capability for quantitative image assessment of different types of cancer including for invasive lobular carcinoma with comparatively low metabolic activity. Quantitative imaging performance assessment with phantoms demonstrates improved contrast recovery and spill-over ratio for this PET technology when compared to other commercial organ-dedicated PET systems with similar spatial resolution. Recovery coefficients were measured to be 0.21 for the 1 mm hot rod and up to 0.89 for the 5 mm hot rod of NEMA NU-4 Image Quality phantom. Discussion: Demonstrated ability to accurately reconstruct activity in tumors as small as 5 mm suggests that the Radialis PET technology may be well suited for emerging clinical applications such as image guided assessment of response to neoadjuvant systemic treatment (NST) in lesions smaller than 2 cm. Also, our results suggest that, while spatial resolution greatly influences the partial volume effect which degrades contrast recovery, optimized count rate performance and image reconstruction workflow may improve recovery coefficients for systems with comparable spatial resolution. We emphasize that recovery coefficient should be considered as a primary performance metric when a PET system is used for accurate lesion size or radiotracer uptake assessments.
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Purpose To investigate the feasibility of low-dose positron emission mammography (PEM) concurrently to MRI to identify breast cancer and determine its local extent. Materials and Methods In this research ethics board-approved prospective study, participants newly diagnosed with breast cancer with concurrent breast MRI acquisitions were assigned independently of breast density, tumor size, and histopathologic cancer subtype to undergo low-dose PEM with up to 185 MBq of fluorine 18-labeled fluorodeoxyglucose (18F-FDG). Two breast radiologists, unaware of the cancer location, reviewed PEM images taken 1 and 4 hours following 18F-FDG injection. Findings were correlated with histopathologic results. Detection accuracy and participant details were examined using logistic regression and summary statistics, and a comparative analysis assessed the efficacy of PEM and MRI additional lesions detection (ClinicalTrials.gov: NCT03520218). Results Twenty-five female participants (median age, 52 years; range, 32-85 years) comprised the cohort. Twenty-four of 25 (96%) cancers (19 invasive cancers and five in situ diseases) were identified with PEM from 100 sets of bilateral images, showcasing comparable performance even after 3 hours of radiotracer uptake. The median invasive cancer size was 31 mm (range, 10-120). Three additional in situ grade 2 lesions were missed at PEM. While not significant, PEM detected fewer false-positive additional lesions compared with MRI (one of six [16%] vs eight of 13 [62%]; P = .14). Conclusion This study suggests the feasibility of a low-dose PEM system in helping to detect invasive breast cancer. Though large-scale clinical trials are essential to confirm these preliminary results, this study underscores the potential of this low-dose PEM system as a promising imaging tool in breast cancer diagnosis. ClinicalTrials.gov registration no. NCT03520218 Keywords: Positron Emission Digital Mammography, Invasive Breast Cancer, Oncology, MRI Supplemental material is available for this article. © RSNA, 2024 See also commentary by Barreto and Rapelyea in this issue.