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A New Breast Imaging Option? | Focus on AI Safety February 12, 2024
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Together with
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“To ensure the safe and effective implementation of AI in clinical settings, the concerns around AI shortcomings must be addressed.”
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Ross J et al, writing in Clinical Radiology on their proposal to create a program to track postmarket AI performance.
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When it comes to mammography screening for women with dense breast tissue, radiologists have long looked for alternatives to established modalities like MRI and ultrasound. In a paper in Radiology: Imaging Cancer, researchers put a new twist on an older technology, positron emission mammography (PEM).
Molecular imaging technologies like PEM have been investigated for years as potential adjuncts to conventional mammography due to the challenges X-ray imaging has with dense breast tissue.
- These technologies have carried different names – PEM, breast-specific gamma imaging, molecular breast imaging – but in the end all have fallen short due to the higher radiation dose they deliver compared to mammography.
But Canadian startup Radialis has developed a new version of PEM with its Radialis PET Imager that drastically cuts radiation dose by targeting specific organs, enabling clinicians to use far lower doses of radiopharmaceuticals. The company received clearance for the system in 2022.
- Radialis touts its system as having high spatial resolution and a small field of view thanks to digital detectors with thousands of silicon sensors that can be placed next to the target organ; this makes it well-suited for imaging specific organs like the breast.
In the new paper, Canadian researchers tested the Radialis system as an adjunct to X-ray mammography in a pilot study of 25 women recently diagnosed with breast cancer.
- They wanted to see if PEM performed as well as breast MRI, but with fewer false positives and a radiation dose closer to screening mammography.
Women underwent PEM at three FDG dose levels – 37, 74, or 185 MBq (for comparison, standard whole-body PET uses 370 MBq, a level that translates to a radiation exposure of 6.2-7.1 mSv). Researchers found …
- PEM had sensitivity of 87% across all FDG dose levels (MRI was 100%)
- The sample size was too small to detect statistically significant differences in sensitivity between dose levels
- PEM had specificity of 95%
- PEM detected 96% of known index malignant lesions (24 of 25), with the one miss occurring in a patient at the 37MBq level
- PEM’s radiation dose ranged from 0.62-1.42 mSv, versus 0.44 mSv for a two-view screening digital mammogram
The Takeaway
The findings show that PEM with the Radialis system is a feasible adjunctive breast imaging modality at a radiation dose that’s mostly acceptable relative to X-ray-based mammography. But (as always) additional studies with larger patient populations are needed.
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Best in KLAS PACS
Intelerad’s InSight PACS has been named Best in KLAS for UK and Ireland PACS by KLAS Research. Learn more about the solution that’s been adopted by over 250 healthcare providers across the UK and Ireland.
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Visit TeraRecon at ECR 2024
Discover how TeraRecon’s solutions can deliver clinical decision support across your enterprise and explore the latest updates to their industry-leading advanced visualization software at ECR 2024. Schedule a meeting today.
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- AI Postmarket Evaluation: The number of AI algorithms gaining regulatory approval is skyrocketing, but there’s still a need to track AI safety and how well models work in the real world. That’s the message of a new article in Clinical Radiology by members of the UK’s Royal College of Radiologists AI committee that recommends the creation of an AI postmarket surveillance and evaluation system. It could be modeled on systems already in place for pharmaceutical and surgical devices, and could leverage existing programs like the UK’s PERFORMS system for mammography quality assurance.
- AI Safety Consortium Forms: In the same vein, the US government last week formed the AI Safety Institute, a new body in the National Institutes of Standards and Technology dedicated to advancing safe and trustworthy AI. The group includes over 200 companies and organizations, but interestingly no radiology AI developers are on the list (although a number of universities are). Healthcare AI safety was also the focus of a February 8 House of Representatives hearing, with speakers including Peter Shen of Siemens Healthineers and Ziad Obermeyer, MD, of UC Berkeley.
- Viz.ai Clearance for ICH Algorithm: AI developer Viz.ai has received 510(k) clearance for Viz ICH Plus, an AI algorithm for detecting intracerebral hemorrhage on non-contrast brain CT scans. The model automates the process of identifying, labeling, and quantifying the volume of segmentable brain structures on CT images; Viz AI notes that ICH accounts for up to 15% of all strokes and has high rates of morbidity and mortality. In related news, Viz AI touted six studies on its algorithms presented at the International Stroke Conference last week.
- AI Helps Residents Spot PE: Avicenna.AI’s CINA-PE AI algorithm helped radiology residents detect pulmonary embolism on CT pulmonary angiography exams. In a paper in European Journal of Radiology, researchers found that residents reading CTPA exams of patients with suspected PE (n=196) saw their sensitivity go up using AI (93% vs. 82%); concordance between residents also improved when using AI as measured by kappa (0.88 vs. 0.77). Researchers noted that residents are often the initial interpreters of PE studies after-hours, and AI could improve their accuracy.
- GE to Supply MedQuest: GE HealthCare has signed a three-year deal to supply medical imaging technology to outpatient imaging center operator MedQuest Associates (over 50 imaging centers in 8 US states), with a focus on workflow improvement. The agreement includes digital technologies like GE’s AIR Recon DL MRI reconstruction solution and AIR Touch workflow offering for MRI coil selection, as well as Imaging Protocol Manager, Smart Subscription, and Imaging 360 operations management software.
- Free-Breathing MRI for Heart Disease: French researchers used a deep learning reconstruction algorithm to create cine cardiac MRI sequences acquired during free-breathing scans of patients with suspected ischemic heart disease. In a study of 26 patients in AJR, researchers describe how the DL-ESPIRiT neural network enabled the acquisition of high-quality cine images to assess left ventricular ejection fraction in less time than standard protocols (0.6 vs. 2.4 minutes). The protocol could be useful for cardiac MRI evaluation of patients unable to repeatedly hold their breath.
- Lower CCTA Radiation Dose: Thanks to AI reconstruction, wide 16cm detectors, and a fast 0.25-second gantry rotation time, researchers from China conducted coronary CT angiography scans of patients with irregular heart rhythms at the same radiation dose as those with regular heart rhythms. In a paper in Heliyon, they described scanning 427 patients who got prospective CCTA with ECG triggering on United Imaging Healthcare’s uCT960+ CT scanner. There was no statistically significant difference in radiation dose between patients (2.7 vs. 2.9 mSv, p=0.61); image quality was similar.
- Premier Radiology Buys NationalRad: It’s been a busy time for teleradiology services provider Premier Radiology Services. The company last week acquired NationalRad, a Florida-based subspecialty teleradiology company, in a deal that expands Premier’s service offering, especially in MSK and neuroradiology MRI. Just prior to that, Premier signed an extension through 2030 to its contract with occupational medicine provider Concentra, giving Premier continued access to Concentra’s 540 medical centers across the US.
- MRI Scan Hesitancy: Older Asian Americans are less likely than their White peers to participate in research involving MRI scans, and this hesitancy could affect the quality of future dementia research. In a study in Alzheimer’s & Dementia: Translational Research & Clinical Interventions, researchers surveyed 246 people over 65, finding that South Asians and East Asians had lower desire to learn of MRI results for both serious findings and benign conditions. Older Asians were also less likely to believe that healthy people should participate in research studies.
- Rao Joins CARPL Board: Radiology thought leader Vijay Rao, MD, has joined the advisory board of AI platform CARPL.ai. Rao is professor of radiology and senior vice president of enterprise imaging at Jefferson Health, and was president of RSNA 2018. In the research field, she is perhaps best known for her work in radiology economics.
- IBA to Buy Dosimetry Firm Radcal: Belgian radiation oncology firm Ion Beam Applications has signed a deal to acquire Radcal, a California-based provider of X-ray measurement products such as dosimeters. Radcal generates $6M in revenues, and IBA expects the deal to support its continued growth in the dosimetry and quality assurance market, especially in the US.
- 3M on Track with Healthcare Spinoff: 3M is on track to spin off its healthcare unit into a new company called Solventum in the first half of 2024, the company confirmed during its recent Q4 investor call. The Medical Solutions Division reported revenue growth in the low single digits, while revenue for 3M’s other business units continued a downward trend. 3M’s M*Modal front-end speech recognition solution was a KLAS Research awardee last week.
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MRI Access and the Cost of Inpatient Stays
Longer inpatient stays due to delayed MRI access are a long-standing and costly issue for hospital systems. Find out how STAGE from SpinTech MRI can reduce your MRI backlog and inpatient stays by shortening brain scan times by 30%.
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Monitoring, Benchmarking, Data Privacy, and Ethics in AI
Join Bayer’s Calantic Digital Solutions for a February 28 presentation at ECR 2024 exploring how ethics shape AI’s trajectory, societal impact, and deployment. See Calantic’s entire program and schedule your demo today.
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The Evolution of Deep Learning-Based MRI
Learn how deep learning-based MRI reconstruction methods like GE HealthCare’s AIR Recon DL have helped increase spatial resolution while allowing for shorter acquisition times.
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