MRI’s Value for Prostate Screening

Among cancer screening tests, prostate screening could be the most problematic. But a new study published this week in JAMA Network Open offers guidance on the role that MRI can play in making prostate screening more effective – and opening the door to population-based screening.

The problem with prostate screening is that PSA tests often discover disease that’s either indolent or slow-growing. 

  • This can lead to a cascade of interventions that are expensive and have harms of their own. 

But prostate cancer remains a common – and deadly – cancer, with 1.5M cases globally in 2022, and it’s the second most commonly occurring cancer in men after lung cancer.

  • Given these statistics, there has to be a way to perform prostate screening more effectively.

MRI offers one such alternative, and a clinical consensus has emerged that performing a single MRI scan after a positive PSA result can help stratify men before biopsy. 

  • In this scenario, men might not be referred to biopsy if their MRI scan is negative, and adoption of this protocol has helped reduce prostate biopsies in PSA-positive men while still detecting clinically significant cancer.   

But if one MRI scan is good, are repeat MRI scans even better? In the new study, Swedish researchers investigated this question in a secondary analysis of the STHLM3-MRI trial, which involved repeat screening of 1.5k men 2-3 years after an original prostate screening.

Of the group who got repeat PSA and MRI screening, 667 men had PSA levels of 3 ng/mL or higher, the threshold for MRI testing, with the repeat scans finding … 

  • 51 men (7.6%) had equivocal lesions (PI-RADS score of 3)
  • 33 men (4.9%) had suspicious lesions (PI-RADS score of 4)
  • Only 10 men (1.5%) had lesions with PI-RADS scores of 4 or greater

The findings led the authors to conclude that cancer detection was “limited” in the second round of PSA and MRI prostate screening, and detection of low-grade tumors was low.

The Takeaway

At first blush, STHLM3-MRI may seem like a negative study, but it actually helps frame the debate over prostate cancer screening and MRI’s role by omitting the need for multiple repeat scans. The results also give clinicians confidence that it’s safe to omit prostate biopsies in men who have a single negative MRI result – a key finding in reducing the downstream costs of any population-based screening program.

Can AI Direct Breast MRI?

A deep learning algorithm trained to analyze mammography images did a better job than traditional risk models in predicting breast cancer risk. The study shows the AI model could direct the use of supplemental screening breast MRI for women who need it most. 

Breast MRI has emerged (along with ultrasound) as one of the most effective imaging modalities to supplement conventional X-ray-based mammography. Breast MRI performs well regardless of breast tissue density, and can even be used for screening younger high-risk women for whom radiation is a concern. 

But there are also disadvantages to breast MRI. It’s expensive and time-consuming, and clinicians aren’t always sure which women should get it. As a result, breast MRI is used too often in women at average risk and not often enough in those at high risk. 

In the current study in Radiology, researchers from MGH compared the Mirai deep learning algorithm to conventional risk-prediction models. Mirai was developed at MIT to predict five-year breast cancer risk, and the first papers on the model emerged in 2019; previous studies have already demonstrated the algorithm’s prowess for risk prediction

Mirai was used to analyze mammograms and develop risk scores for 2.2k women who also received 4.2k screening breast MRI exams from 2017-2020 at four facilities. Researchers then compared the performance of the algorithm to traditional risk tools like Tyrer-Cuzick and NCI’s Breast Cancer Risk Assessment (BCRAT), finding that … 

  • In women Mirai identified as high risk, the cancer detection rate per 1k on breast MRI was far higher compared to those classified as high risk by Tyrer-Cuzick and BCRAT (20.6 vs. 6.0 & 6.8)
  • Mirai had a higher PPV for predicting abnormal findings on breast MRI screening (14.6% vs. 5.0% & 5.5%)
  • Mirai scored higher in PPV of biopsies recommended (32.4% vs. 12.7% & 11.1%) and PPV for biopsies performed (36.4% vs. 13.5% & 12.5%)

The Takeaway
Breast imaging has become one of the AI use cases with the most potential, based on recent studies like PERFORMS and MASAI, and the new study shows Mirai could be useful in directing women to breast MRI screening. Like the previous studies, the current research is pointing to a near-term future in which AI and deep learning can make breast screening more accurate and cost-effective than it’s ever been before. 

MRI Findings Linked to Psychosis

Over one-quarter of patients presenting with a first episode of psychosis had some kind of abnormality on brain MRI scans, and about 6% of all findings were clinically relevant and required a change in patient management. Writing in JAMA Psychiatry, researchers from the UK and Germany say their study suggests that MRI should be used in the clinical workup of all patients presenting with psychosis. 

Psychosis caused by another medical condition – called secondary psychosis – can have causes that produce brain abnormalities visible on MRI scans. These are findings like white-matter hyperintensities that – while not themselves a form of pathology – are sometimes associated with more serious conditions like cognitive decline. 

MRI scans of people experiencing their first psychotic episode could detect some of these abnormalities before subsequent episodes occur. But at present there is no consensus as to whether MRI should be used in the evaluation of patients presenting with first-episode psychosis. 

In a meta-analysis, researchers wanted to investigate the prevalence of intracranial radiological abnormalities on MRI scans of patients with first-episode psychosis. They reviewed 12 independent studies that covered a total of 1,613 patients. Findings across all the studies included:

  • A prevalence rate of 26.4% for all radiological abnormalities 
  • A prevalence rate of 5.9% for clinically relevant abnormalities 
  • One in 18 patients had a change in management after an MRI scan
  • White-matter hyperintensities were the most common abnormality, with a prevalence of 7.9% for all abnormalities and 0.9% among clinically relevant abnormalities

Given the impact of MRI on patient management, the authors suggested that performing routine scans on people after their first psychotic episode could have both clinical and economic benefits. This could be especially true due to the financial costs of failing to identify a clinically relevant abnormality that could lead to a later episode if not treated.

The Takeaway 

These findings may break the logjam over whether MRI should be routinely used in the evaluation of patients with first-episode psychosis. The authors note that while many of the abnormalities found on MRI in the studies they reviewed did not require a change in patient management, abnormalities could be harbingers of poorer patient outcomes, even if they don’t eventually lead to a diagnosis of secondary psychosis.

GE HealthCare’s MRI Contrast Play

GE HealthCare has expanded its MRI contrast portfolio with the European debut of Pixxoscan. The gadolinium-based contrast agent gives GE another macrocyclic gadolinium-based contrast agent to sell in Europe, in addition to its Clariscan GBCA.

MRI contrast developers have been working to address one of the most persistent problems in MRI: their reliance on gadolinium. Gadolinium works great for lighting up MR images, but it’s a toxic metal that has to be bonded with a chelate – a sort of molecular cage – in order to be used safely in humans. 

Pixxoscan is a macrocyclic GBCA that’s based on gadobutrol, a formulation already used in Bayer’s Gadovist GBCA and that’s now available generically. Macrocyclic GBCAs are considered more stable and less likely to release gadolinium than linear agents. 

Most linear GBCAs have been barred from the European market since 2017. The FDA never took a similar approach, but the US market has largely shifted from linear GBCAs to macrocyclic agents due to safety concerns. 

GE HealthCare highlighted that Pixxoscan is formulated at twice the concentration of gadolinium ions, which reportedly enables it to be used at half the injection volume of other GBCAs. The company also said that the agent’s cage-like macrocyclic chelate provides high kinetic stability. 

Pixxoscan will start shipping initially in Austria, and GE HealthCare expects to expand it across Europe. A spokesperson didn’t confirm plans for a US rollout.   

Pixxoscan’s launch comes as two of GE HealthCare’s competitors, Guerbet and Bracco, are rolling out their formulations of gadopiclenol, a high-relaxivity agent that can be used at half the dose of conventional GBCAs. The companies collaborated on the development of the agent, which Guerbet is selling as Elucirem and Bracco as Vueway. 

The Takeaway

GE HealthCare’s launch of Pixxoscan gives the company another macrocyclic agent to sell in Europe in addition to Clariscan. The question is how the agent will compete with gadopiclenol from Bracco and Guerbet, which are already touting its dose and relaxivity advantages.

Siemens Healthineers Targets MRI at Shape 2023

Siemens Healthineers kicked-off RSNA announcements season with its Shape 23 event, highlighted by a pair of forthcoming MRIs that should serve as the cornerstones of its high-end lineup for years to come.

Magnetom Cima.X – Siemens reinforced its already-solid 3T MR lineup with its new Magnetom Cima.X, calling it the company’s “strongest 3T MRI system ever.”

The Magnetom Cima.X owes that “strongest 3T” title to its new Gemini Gradients, which achieve 200 mT/m amplitude and 200 T/m/s slew rate performance. That’s a 2.5x increase from Siemens’ previous 3T MRIs and it’s higher than any other clinically released whole-body MRI. 

The Magnetom Cima.X also features Siemens Healthineers’ …

  • Benchmark 3T magnet
  • Deep Resolve AI image reconstruction for up to 50% faster scans
  • Open Recon for integrating custom reconstruction and post-processing solutions
  • BioMatrix Technology to automatically adjust exams based on patient biovariability
  • myExam Companion for streamlining technologist workflows

Magnetom Terra.X – Siemens’ new Magnetom Terra.X 7T MR is the long-awaited successor to the Magnetom Terra (the first FDA-cleared 7T MR), bringing improved clinical and research performance. The Magnetom Terra.X leverages Siemens’ new Ultra IQ Technology to achieve even greater image quality and visualization of small structures, Deep Resolve for image reconstruction-based speed and image enhancements, and Open Recon to support custom reconstructions.

The Takeaway

Although both MRIs are still under development, their starring role in Siemens Healthineers’ big RSNA event underscores their significance to Siemens’ high-end MRI lineup, and gives a glimpse of features to expect in future 1.5T and 3T MR launches. That’s especially notable given that Siemens’ last two RSNA announcements focused on its new low-field 0.55T MRIs, and it hasn’t launched any high-field systems in over three years.

MRI Accessibility Advantage

Memorial MRI and Diagnostic’s COO Todd Greene starred in a recent Aunt Minnie webinar, detailing the role MRI accessibility plays in the Texas imaging group’s strategy, and sharing some very relevant takeaways for imaging providers and vendors.

Founded in 2001, Memorial MRI and Diagnostic (MMD) operates 16 imaging centers across Texas, including eight in greater Houston and eight Dallas-area locations added through its 2021 acquisition of Prime Diagnostic Imaging. 

  • MMD’s strategy focuses on integrating its imaging centers within their local communities, making patient access and referring physician relationships particularly important.

In addition to proximity to patients, MMD’s MRI accessibility strategy historically focused on maintaining a fleet of open bore 1.5T MRI scanners to accommodate larger and claustrophobic patients. 

  • This is especially important given that many of MMD’s patients are “Texas sized” or don’t realize they’re claustrophobic until the scan begins. 

That strategy started to change when MMD installed United Imaging’s 3T uMR OMEGA ultra-wide-bore (75 cm), allowing it to scan larger and claustrophobia-prone patients (plus all other patients) without open MRIs’ scan speed and image quality tradeoffs. 

  • The uMR OMEGA was MMD’s first 3T MRI at any of MMD’s imaging centers, although Greene expects its patient and referrer-friendly advantages to drive a continued shift towards wide-bore 3T MRI systems.

Greene also detailed Memorial MRI’s alliance with United Imaging (the webinar’s sponsor), specifically highlighting the scalability of UIH’s “Software for Life” (scanners automatically updated with future software) and “All-In” (scanners include all possible features/packages) policies.

As the webinar wrapped up, Greene warned imaging centers not to blindly rely on what has worked in the past, predicting that “ease of access is what is going to shape the future of healthcare.” 

The Takeaway

We get plenty of insights from the medical center side of radiology, but it’s still rare to hear from imaging center chains. That makes MDD’s insights particularly useful for the many regional imaging providers who’d like to improve MRI accessibility (without open MRI’s tradeoffs) and for MRI OEMs looking to drive 3T MRI adoption in an imaging provider segment that historically favored 1.5T systems.

RSNA 2021 Reflections

The first in-person RSNA since COVID is officially a wrap. Hope you had a blast if you made it to Chicago and a productive week if you stayed home. We also hope you enjoy The Imaging Wire’s big takeaways from what might have been both the most special and most subdued RSNA ever.

Crowds & Conversations – We were already expecting 50% lower attendance than RSNA 2019, but the exhibit hall and cab lines looked more like 70% below 2019’s crowds (even less on Sunday & Wednesday). That said, most of the stronger companies had steady booth traffic and nearly every exhibitor emphasized that the attendees who did show up were ready to have high-quality conversations.

Focus on Productivity – Just about every product message at RSNA focused on productivity and efficiency, often with greater emphasis than clinical effectiveness. The modality-based efficiency enhancements seemed to be the most impactful, which is good news for technologist bandwidth and patient throughput, but might be bad news for rad burnout unless informatics/AI efficiency can catch up (it doesn’t seem like that happened this year).

Modality Milestones – The major OEMs did a good job making modalities cool again, debuting milestone innovations across both their MR (low-helium, low-field, reconstruction, coils) and CT (photon-counting, spectral, upgradability) lineups. We also saw the latest scanners take big strides in operator efficiency and patient experience. There weren’t many breakthroughs with X-ray or ultrasound, and most point-of-care ultrasound OEMs stayed home (rads aren’t their market anyway), but attendees seemed okay with that.

AI Showcase – The RSNA AI Showcase had solid traffic and high energy (especially on Mon & Tues), helped by continued AI buzz and the fact that RSNA finally let AI vendors out of the basement. The AI Showcase highlighted many of the trends we’ve been seeing all year, including larger vendors transitioning to AI platform strategies, an increased focus on workflow integration and care coordination, and a greater emphasis on radiologist efficiency. There were also far fewer brand-new AI tools than previous years, as many vendors focused on improving their current products and/or expanding their portfolio via partnerships. 

PACS Cloud Focus – PACS vendors continued to place a major emphasis on their respective cloud advantages, and there was a widespread consensus that cloud is on every imaging IT roadmap. The PACS vendors seemed to talk less about multi-ology enterprise imaging than previous years, and expanding EI beyond radiology/cardiology still seemed pretty futuristic for most players. It was also quite clear that most of the PACS players’ AI marketplaces/platforms haven’t been as prioritized as earlier announcements might have suggested.

Best RSNA Since… 2019 – We’ve heard some folks saying this was the “best RSNA ever” because it was easy to get around and it was great to see everyone, but those seem more like pandemic silver linings than “best ever” qualifications. Still, the imaging industry made the most of RSNA 2021, and everyone seemed truly happy to be together again after two long years of working from home. As long as COVID cooperates, we should be set up for an excellent RSNA 2022.

GE’s Productive RSNA

GE Healthcare had another busy RSNA, highlighted by several major modality launches and an overarching focus on helping imaging teams be more productive. 

Return to MR Hardware – After focusing on AIR Recon DL during the last two RSNAs, GE Healthcare’s MR team made sure to roll-out new hardware at this year’s show. 

  • GE’s MR section was headlined by its new SIGNA Hero 3T MR, which brings a wide range of improvements (image quality, workflows, productivity, comfort, reconstruction, helium & energy), and a major focus on operator efficiency.  
  • GE also unveiled the SIGNA Artist Evo, which allows health systems / imaging centers to upgrade their existing 1.5T 60cm-bore MRs with 70cm bore systems (w/ AIR Recon DL & AIR Coils), without the construction and downtime typically required when upgrading to a net new MR system.

GE’s Scalable CT Platform – GE unveiled the unique Revolution Apex platform, which offers the modularity and scalability to cover a wide range of current and future needs, and represents GE’s biggest CT launch since 2014. 

  • The FDA-cleared Revolution Apex CT is available with multiple detector coverage configurations (40mm, 80mm, 160mm, upgradable w/o replacing gantry) and is offered with GE’s new Smart Subscription service (allows software upgrades/downgrades, plus auto updates). 
  • True to GE’s productivity focus, the Revolution Apex also includes a range of features to improve technologist efficiency and/or expand clinical applications (e.g. “Effortless Workflow,” patient positioning camera, TrueFidelity DLIR, motion correction for cardiac).

Much More – GE Healthcare has been busy throughout 2021, so although the other products in its RSNA booth were still quite new, they’ve already been detailed in previous Imaging Wire issues. Some of these other highlights include its in-development Photon Counting CT, it’s now FDA-approved Endotracheal Tube X-ray AI tool, its StarGuide SPECT/CT scanner, and its recent alliance with Optellum.

Philips’ RSNA MRIs

After two straight solution-centric RSNAs, Philips’ RSNA 2021 booth will be headlined by a pair of new MR systems (plus some MR solutions) and a major focus on operational efficiency.

MR 5300 – The FDA-cleared MR 5300 (1.5T) is Philips’ second helium-free BlueSeal MR scanner, arriving three years after the Ingenia Ambition X, and launching with new AI-powered features intended to automate clinical and operational tasks. Philips also emphasized the image quality advantages of the MR 5300’s 55cm field-of-view and dStream Breeze coils.

MR 7700 – Philips’ forthcoming MR 7700 system (3T) is positioned for both clinical and research use, although its features and messaging largely emphasize its value to researchers. The MR 7700 boasts new multinuclear clinical capabilities, including diffusion imaging and advanced neuroscience sequences, while its XP gradients (65 mT/m) support neuroscience.

MR Workspace – Philips’ new MR Workspace is intended to support technologist productivity, providing a dashboard that automates the planning and execution of many routine scans and supports decision making by suggesting the most suitable Exam Card for each patient. MR Workspace will be included with all new and installed Philips MR scanners. 

Philips SmartSpeed – The SmartSpeed image reconstruction platform is designed to speed up image acquisition and enhance image quality, leveraging Philips’ Compressed SENSE acquisition technique and AI to reconstruct full images from under-sampled data, “while maintaining virtually equivalent image quality.”

The Takeaway – Philips’ MR lineup has been relatively quiet during the last few years, while its main MR competitors made some solid progress (particularly w/ reconstruction, operability, comfort, and low-helium tech). It seems like that won’t be the case at RSNA 2021.

Siemens’ Healthineers Hardware Evolution

Siemens Healthineers’ Shape 22 pre-RSNA event featured a pair of ambitious hardware announcements that stand to expand what can be done with CT exams and where MRIs can be performed.

NAEOTOM Alpha PCCT – Siemens Healthineers confirmed its pole position in the Photon-Counting CT race, officially launching its NAEOTOM Alpha scanner. Although the NAEOTOM Alpha already received a rare marketing head-start from the FDA, this week’s launch begins its official 2022 rollout, and provides new details about this milestone product:

  • Far higher image quality than CT
  • Provides much more imaging data and new levels of CT-based insights
  • Expands CT to new cardiac, oncology, and pulmonology use cases
  • Allows 50% lower radiation dosage, could shift exams to non-contrast
  • Supports Siemens’ core solutions, including operability and AI-based diagnosis
  • Cleared in US and Europe, 20 systems already installed, 8k patients scanned
  • PCCT expected to become the main CT technology within 10 years
  • Siemens is holding another NAEOTOM Alpha event today (Nov. 18)
  • Siemens might be first, but we’re seeing more PCCT activity from GE Healthcare, and Canon and Philips aren’t far behind

MAGNETOM Free.Star MRI – One year after introducing the MRI-expanding MAGNETOM Free.Max, Siemens continued its MRI accessibility push, revealing the “disruptively simple” MAGNETOM Free.Star. The new Free.Star MRI will inherit much of the MAGNETOM Free.Max’s accessibility-friendly qualities (0.55T, small/light, low helium & installation requirements), and will have the ambitious goal of supporting the half of the world’s population that doesn’t have MRI access. The MAGNETOM Free.Star is still early-stage (it hasn’t begun the FDA process), but it’s massive healthcare ambitions make it worth keeping an eye on.

The Takeaway – The NAEOTOM Alpha is expected to be the start of a major shift towards Photon-Counting CT, while the new MAGNETOM Free.Max and Free.Star could expand where MRIs are used. That makes these extremely significant products.

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