The aim of this study is to evaluate the performance of the Radialis organ-targeted positron emission tomography (PET) Camera with standardized tests and through assessment of clinical-imaging results. Sensitivity, count-rate performance, and spatial resolution were evaluated according to the National Electrical Manufacturers Association (NEMA) NU-4 standards, with necessary modifications to accommodate the planar detector design. The detectability of small objects was shown with micro hotspot phantom images. The clinical performance of the camera was also demonstrated through breast cancer images acquired with varying injected doses of 2-[fluorine-18]-fluoro-2-deoxy-D-glucose (18F-FDG) and qualitatively compared with sample digital full-field mammography, magnetic resonance imaging (MRI), and whole-body (WB) PET images. Micro hotspot phantom sources were visualized down to 1.35 mm-diameter rods. Spatial resolution was calculated to be 2.3 ± 0.1 mm for the in-plane resolution and 6.8 ± 0.1 mm for the cross-plane resolution using maximum likelihood expectation maximization (MLEM) reconstruction. The system peak noise equivalent count rate was 17.8 kcps at a 18F-FDG concentration of 10.5 kBq/mL. System scatter fraction was 24%. The overall efficiency at the peak noise equivalent count rate was 5400 cps/MBq. The maximum axial sensitivity achieved was 3.5%, with an average system sensitivity of 2.4%. Selected results from clinical trials demonstrate capability of imaging lesions at the chest wall and identifying false-negative X-ray findings and false-positive MRI findings, even at up to a 10-fold dose reduction in comparison with standard 18F-FDG doses (i.e., at 37 MBq or 1 mCi). The evaluation of the organ-targeted Radialis PET Camera indicates that it is a promising technology for high-image-quality, low-dose PET imaging. High-efficiency radiotracer detection also opens an opportunity to reduce administered doses of radiopharmaceuticals and, therefore, patient exposure to radiation.
Purpose: To investigate the feasibility of low-dose Positron Emission Mammography (PEM) to identify breast cancer. Materials and Methods: In an REB-approved ongoing clinical trial, which started in December 2019, all newly diagnosed women with breast cancer who had not undergone neoadjuvant chemotherapy and consented to the study were randomly assigned independently of their mammographic breast density, tumor size, and histopathology cancer subtype to perform PEM using a novel organ-targeted PET system(Radialis PET Imager, Radialis Inc., FDA cleared to image and measure the distribution of injected positron-emitting radiopharmaceuticals) with either 1mCi, 2mCi or 5 mCi of 18F-FDG. The PEM images acquired 1 and 4 hours after 18F-FDG administration were reviewed in consensus by two fellowship-trained breast radiologists blinded to cancer location. PEM imaging features of known malignancies and additional PEM findings were recorded and correlated with histopathology as the ground truth. Results: Our cohort comprised 22 women with a median age of 51 years (range 32-85) with 88 completed bilateral sets of images where 23 cancers (18 invasives, and 5 in situ) were present. The median invasive cancer size on surgical pathology was 28 mm (range: 3-120). Out of 18 invasive cancers, the only PEM images that did not visualize cancer (2 invasive lobular cancers and 2 in-situ cancers) were acquired with the lowest dose of 18F-FDG (1 mCi). A total of 6 (27.3%) subjects received 1mCi 18F-FDG with 5 invasive cancers, 7 (31.8%) of patients received 5 mCi 18F-FDG with 7 invasive cancers, and 9 (40.9%) of patients received 5 mCi 18F-FDG with 6 invasive cancers. A total of 3 false-positive images of benign findings were also present. No additional cancers were identified exclusively by PEM. The PEM performance was similar following an additional 3-hour interval for radiotracer uptake. Conclusion: This preliminary data results show the feasibility of invasive breast cancer detection with a decreased 18F-FDG dose, possibly due to the novel PEM system detectors increasing the sensitivity to radiotracer and the perceived spatial resolution by the visual assessment. Larger-scale clinical trials are required to consolidate our preliminary findings. Clinical Relevance: A novel organ-targeted PET system enables the detection of invasive breast cancer using low-dose PEM, potentially emerging as a promising novel imaging tool. Citation Format: Vivianne Freitas, Michael L. Waterston, Ken O. Olsen, Oleksandr Bubon, Shayna Parker, Brandon Baldassi, Borys Komarov, Samira Taeb, Alla Reznik. An Emerging Technology for Breast Cancer Detection - Preliminary Data of Breast Cancer Detection using Novel Low Dose Positron Emission Mammography [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P2-09-01.
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