The Food and Drug Administration (FDA) has 

expanded the 510(k) clearance for GE Healthcare’s AIR Recon DL

, enabling radiologists to apply the adjunctive deep learning-based technology to 3D sequences as well as the company’s PROPELLER motion-insensitive sequences for magnetic resonance imaging (MRI).

Noting enhanced image sharpness and an improved signal-to-noise (SNR) ratio, GE Healthcare said the compatibility of AIR Recon DL with 3D MRI imaging reduces the need for repeat 2D scans and may facilitate quick imaging results.

For pediatric, neurodegenerative, geriatric, and claustrophobic patients who may have trouble staying still for MRI exams, GE Healthcare noted the combination of PROPELLER sequencing and AIR Recon DL should lead to shorter exam times, faster patient throughput and an enhanced patient experience.

“By expanding AIR Recon DL to 3D and PROPELLER, GE Healthcare has closed the gaps in our ability to provide improved image quality and patient experience to all our patients across exam types, particularly for brain imaging where we rely heavily on 3D sequences and musculoskeletal imaging where PROPELLER is important for reducing image quality variability and eliminating repeat sequences due to motion,” noted Tiron Pechet, MD, an assistant professor of radiology at the University of Massachusettes Medical School and an assistant medical director with Shields Health Care Group.

In addition to being available on the GE Healthcare’s new MRI scanners, the expanded applications of AIR Recon DL to 3D and PROPELLER sequences will be available as upgrades for previously installed 1.5T and 3.0T MRI systems from the company, according to GE Healthcare.

Articles

AIR Recon DL, a deep learning-based image reconstruction software, will now be available with 3D sequences as well as PROPELLER motion-insensitive sequences on magnetic resonance imaging (MRI) scanners from GE Healthcare.

MRI Deep Learning Software from GE Healthcare Gets Expanded FDA Clearance

Given the recent challenges with supplies of iodinated contrast media (ICM) at various facilities, the authors of a new publication maintain that ultrasound and magnetic resonance imaging (MRI) can be effective imaging options for a variety of head and neck pathology.

In their recently published article in the 

Journal of Medical Imaging and Radiation Oncology

, the authors acknowledged that operator experience and accessibility factor into the use of ultrasound and MRI but maintained that they are safe and viable alternatives for imaging of the neck and head.

“Both modalities have the distinct advantage of eliminating radiation exposure and not requiring ICM, certainly making them safer for use in the (pediatric), cancer-predisposed screen population and for surveillance imaging,” wrote study co-author Timothy Fiori, MBBS, who is affiliated with the Department of Medical Imaging at Fiona Stanley Hospital in Perth, Australia, and colleagues.

The article authors pointed out that incidental thyroid nodules are commonly detected on chest computed tomography (CT) or positron emission tomography (PET) CT. However, for subsequent workup of incidental thyroid nodules, the researchers noted a lack of evidence basis for contrast-enhanced computed tomography (CECT). Alternately, thyroid ultrasound, in concert with thyroid function testing, provides an array of benefits, including identification of suspicious sonographic findings that may suggest possible malignancy, according to Fiori and colleagues.

For palpable salivary gland masses, Fiori and colleagues noted that ultrasound is a first-line modality that can help differentiate between extra-glandular nodal disease and intracapsular glandular pathology. While ultrasound is limited in the assessment of perineural disease, deep lobe parotid masses and minor gland involvement, the article authors maintained that it could aid clinicians in ascertaining the need for subsequent MRI or CT imaging for malignant, large, or trans-spatial lesions. In comparison to CECT, Fiore and colleagues said MRI is advantageous for the staging of salivary gland lesions and perineural disease due to enhanced soft tissue resolution.

For neck masses in children, the article authors explained that ultrasound is beneficial in differentiating between vascular anomalies, congenital abnormalities, reactive benign nodal disease, and malignancy.

“(Ultrasound) can accurately characterize the lesion, size and consistency of a presenting focal lesion, differentiate vascular malformations via Doppler interrogation and facilitate FNA (fine needle aspiration) biopsy,” noted Fiori and colleagues.

Referencing 2017 guidelines from the American Academy of Otolaryngology-Head and Neck Surgery, Fiori and colleagues said CECT or neck MRI are recommended first-line imaging for adult neck masses that are deemed to be at risk of malignancy.

 Facilitating detailed imaging of the extent and architecture of tumors, MRI helps differentiate between malignant and benign lesions and enables clinicians to have more accuracy with tumor subtyping, according to the article authors. Fiori and colleagues maintained that MRI is “strongly recommended” for diagnosing skeletal-based, paraspinal and indeterminate soft tissue masses.

Noting that ultrasound has been recommended by the United Kingdom Royal College of Radiologists for first-line imaging in confirming soft tissue masses, Fiori and colleagues said the modality shows the vascularity of neck masses, differentiates between solid and cystic masses, and identifies potential issues with structures adjacent to masses.

1. Fiori T, Lisewski D, Flukes S, Wood C, Gibson D. Lessons learnt from the global iodinated contrast media shortage in head and neck imaging. 

 2022 Sep 20. doi: 10.1111/1754-9485.13472. Online ahead of print.

2. Pynnonen MA, Gillespie MB, Roman B, et al. Clinical practice guideline: evaluation of the neck mass in adults executive summary. 

3. Smith SE, Salanitri J, Lisle D. Ultrasound evaluation of soft tissue masses and fluid collections. 

In light of recent shortages of iodinated contrast media, researchers from Australia suggest in a new publication that ultrasound and magnetic resonance imaging (MRI) can be viable first-line imaging options for a number of non-urgent presentations of the head and neck.

A Closer Look at Ultrasound and MRI Alternatives for Head and Neck Imaging

In a newly published meta-analysis examining breast density and current breast cancer screening modalities, researchers reaffirmed the significant link between extremely dense breasts and breast cancer risk and suggested that supplemental magnetic resonance imaging (MRI) screening may be advantageous in this higher-risk patient population.

In their review of nine observational digital mammography studies and data from a total of 386,590 women who had breast imaging, researchers examined the correlation between breast cancer risk and mammographic density assessed via the Breast Imaging Reporting and Data Systems (BI-RADS) 5th edition. According to the meta-analysis, published in 

, the cohorts in the included studies were predominantly comprised of women between 50 and 70 years of age with median ages ranging between the early and late fifties.

Women with extremely dense breast tissue (BI-RADS D) had a 2.11-fold increased risk for breast cancer in comparison to women with scattered dense breast tissue or average breast density (BI-RADS B), according to the study. After adjustments for the covariates of age and body mass index, researchers said a subsequent sensitivity analysis revealed a 1.83-fold higher risk for breast cancer for the BI-RADS D group in comparison to those in the BI-RADS B group.

“(Drawing from research involving current widely used breast density measurement tools), this systematic review, based on data of 386,590 women, provides further evidence that having extremely dense breast tissue (BI-RADS density D) is significantly associated with increased breast cancer risk compared to having scattered dense breast tissue (BI-RADS density B),” wrote study co-author G.H. de Bock, Ph.D, who is affiliated with the Department of Epidemiology at the University Medical Center Groningen and the University of Groningen in the Netherlands, and colleagues.

(Editor’s note: For related content, see “

New Mammography Study Examines Association Between Breast Density Changes and Breast Cancer Risk

The researchers also found that women with BI-RADS D had a 3.89-fold increased breast cancer risk in comparison to women in the BI-RADS A category (extremely fatty breast tissue). Noting that this risk estimate is lower than estimates from previous studies, de Bock said this could be attributed to different reference groups and density classifications used in studies as well as the advent of digital mammography.

The study authors note that the BI-RADS lexicon is reliant upon subjective assessments of qualitative breast density that may be affected by inter-reader variability and possible misclassification. While studies have demonstrated higher accuracy and detection rates with digital mammography in comparison to screen film mammography, de Bock and colleagues noted a “slightly weaker” association between breast density and cancer risk with digital mammography in comparison to screen film mammography.

Acknowledging a reduced sensitivity of mammography for women with dense breasts, de Bock and colleagues “strongly advise” MRI screening in this higher risk population.

“It can be questioned whether a twofold risk (of breast cancer) is strong enough to advocate breast MRI for women with dense breasts,” noted Dr. de Bock and colleagues. “This risk estimate is equal to the lowest risk estimate associated with a strong family history of breast cancer, which is associated with a two- to threefold increased breast cancer risk, and is therefore considered as substantial, also given the high lifetime risk for breast cancer in general population women of about 15 percent.”

In regard to study limitations, the authors noted that only nine studies were included in the meta-analysis and acknowledged variation between the studies with methodology, breast cancer outcomes and whether ductal carcinoma in situ (DCIS) cases were included in studies.

Assessing data from 386,590 women, researchers noted that women with extremely dense breast tissue have more than double the risk for breast cancer in comparison to women with average breast density and nearly four times the risk of women with extremely fatty breast tissue.

What a New Meta-Analysis Reveals About Breast Density, Mammography and MRI Screening

Could an emerging agent have an impact in PET imaging of patients with prostate cancer?

Based upon findings from recent studies, including two prospective phase 3 trials, Blue Earth Diagnostics has announced that their new drug application (NDA) for 

F-rhPSMA-7.3, a prostate-specific membrane antigen (PSMA)-targeted agent for prostate cancer imaging

, has been accepted for review by the Food and Drug Administration (FDA).

Consisting of a PSMA-targeted receptor ligand that is internalized by prostate cancer cells, 

F radioisotope for positron emission tomography (PET) imaging, according to Blue Earth Diagnostics, a subsidiary of Bracco Imaging.

The radiohybrid PSMA agent could be a significant advance for facilitating timely staging and treatment of prostate cancer, according to Eugene Teoh, MBBS, MRCP, FRCR, D.Phil, the chief medical officer of Blue Earth Diagnostics.

“Prostate cancer is a leading cause of male cancer-related death worldwide, and accurate localization and staging of the disease is critical in establishing optimal medical management strategies,” said Dr. Teoh. “We believe that the performance of 

F-rhPSMA-7.3, its high PSMA binding affinity and potential for low bladder activity will make it a valuable diagnostic tool that is radiolabeled with 

F for high image quality and readily available patient access.”

In research from a phase 3, prospective multicenter study (SPOTLIGHT) involving 398 men with suspected prostate cancer, 

F-rhPSMA-7.3 had an overall detection rate of 83 percent. For patients who had one or more true positive lesion(s), 

F-rhPSMA-7.3 had a patient-level correct detection rate (CDR) of 56.8 percent, according to the study. The study researchers noted the patient-level CDR was 81.2 percent in a subset of those with a histopathology-only standard of truth (SoT).

“Together, these data support the clinical utility of 

F-rhPSMA-7.3 PET in men with recurrent prostate cancer across a wide PSA (prostate-specific antigen) range,” wrote study author David M. Schuster, M.D., FACR, the director of the Division of Nuclear Medicine and Molecular Imaging at the Emory University School of Medicine.

1. Blue Earth Diagnostics. Blue Earth Diagnostics announces FDA acceptance of new drug application for 

F-rhPSMA-7.3, a radiohybrid prostate-specific membrane antigen-targeted PET imaging agent for prostate cancer. Business Wire. Available at: https://www.businesswire.com/news/home/20220927005159/en/Blue-Earth-Diagnostics-Announces-FDA-Acceptance-of-New-Drug-Application-for-18F-rhPSMA-7.3-a-Radiohybrid-Prostate-Specific-Membrane-Antigen-Targeted-PET-Imaging-Agent-for-Prostate-Cancer . Published September 27, 2022. Accessed September 27, 2022.

2. Schuster DM, SPOTLIGHT Study Group. Detection rate of 

F-rhPSMA-7.3 PET in patients with suspected prostate cancer recurrence: results from a phase 3, prospective, multicenter study (SPOTLIGHT). 

https://ascopubs.org/doi/abs/10.1200/JCO.2022.40.6_suppl.009

One prospective multicenter study found the radiohybrid prostate-specific membrane antigen (PSMA) agent 18F-rhPSMA-7.3 had an 83 percent detection rate in nearly 400 men with suspected prostate cancer.

FDA to Review Blue Earth Diagnostics' Emerging PSMA/PET Agent for Prostate Cancer

Image IQ Quiz: 56-Year-Old Man with Weight Loss and Gradual Abdominal Distention

's Advances in AI monthly roundup is your chance to catch up on the latest AI news, AI-powered imaging modalities and emerging AI research affecting the field of radiology. Review the slideshow below to see highlights from the past month.

Diagnostic Imaging's Advances in AI

Slideshows

Catch up on the top AI-related radiology content of the past month.

Diagnostic Imaging's Advances in AI: September 2022

Eric Postal, MD, is a diagnostic radiologist with the University of Pittsburgh Medical Center. 

Last week, after poking a bit of fun at the idea, I started to share my vision of what a teleradiology fellowship might look like. It included didactic sessions regarding the administrative and logistical stuff that underpins any viable telerad practice. However, I didn’t get into what the fellows would actually be doing with most of their time.

The first type of rotation, as I mentioned last week, would cover 

new material that most radiology residencies completely ignore

. This would include the IT infrastructure that makes teleradiology possible. This knowledge is also vital to modern onsite radwork unless you happen to still be using films … but there is a key difference.

Suppose you’re working in your hospital or imaging center, and suddenly your workstation isn’t doing what you need it to do. Perhaps the software is crashing, your connection to the network is lost, clicking the mouse doesn’t do anything, etc. Maybe you’ve got enough savvy to try this or that, and sometimes your flailing might even work.

However, unless you have been extremely lucky in this field, that is far from the norm. Usually, you wind up limping along at half-speed if you’re not completely dead in the water. There is not much to do but shrug and take a break until tech support gets around to your rescue. Could that be awhile? Sure, but you can’t do much else. Besides, you’re salaried.

Unfortunately, this is not the case in many walks of telerad life. Even if your compensation is not entirely pay-per-click, chances are productivity is still a big piece of your action. Every moment taken away from your ability to read cases is a swipe at your bottom line. You are also working remotely, and IT can’t just stroll down a hallway for a visit. All of the help you’re going to get is via phone (or instant message if that is still working).

That also assumes your tech support is going to be a help. Maybe that won’t be the case. Who knows what bargain-basement service your telerad employer is using in the name of saving a few bucks? Even if the tech support is halfway decent, the first thing they’re going to do with you is go through a tedious series of troubleshooting steps you have heard way too many times before. Is everything plugged in? Turn everything off and on again, etc.

Wouldn’t it be nice if you, as the rad so heavily dependent on your workstation rig, had a decent chunk of the tech support person’s know-how? Maybe you could do your own troubleshooting, and only have to call for help 50 percent, even 25 percent as frequently. When you did wind up talking to tech support, you could begin by telling them everything you already did so they could cross that much off their checklist and skip ahead to whatever you hadn’t already investigated.

On top of that, perhaps you could tell him or her that your fellowship had you spend three-plus months in IT training on all of the stuff relevant to working in telerad. They wouldn’t have to take your word for it that you already confirmed that items A through M aren’t your issue, and to start with N. You would have a fellowship diploma to prove it! This may also be of interest to any prospective employers who might like to have your value-added skills in their workforce.

Fellows would, indeed, spend rotations of their fellowship hanging out with the IT people employed by (or contracted with) the telerad group. It would be part of IT’s job: Have the fellows shadow them, watching and learning whatever tech support was up to or routine maintenance stuff if things were running smoothly.

When there was nothing at all to be done, the IT folks could just sit with the fellows and give them a “what you need to know” practical education. It would be in the techies’ interest after all. A well-versed fellow could help them on the job and might one day be a more self-sufficient customer.

The other major type of rotation would, in fact, be practicing radiology. After all, it wouldn’t be all that helpful for a rad to graduate residency and then spend a year letting his interpretive skills get rusty.

This wouldn’t just be more of the same-old, same-old reading room routine. As I noted before, the fellowship should be in an actual teleradiology group. Well, seasoned telerads would be precisely who the fellows sit with, and the focus would be on seeing and assimilating the habits and skills that made those attendings successful telerads. The fellows would learn how to gain speed and efficiency without sacrificing accuracy.

In residency, speed is far from the goal. One is supposed to be learning the fundamentals of diagnostic radiology. One doesn’t rush things along while a resident is trying to grasp the basics or hurry on to the next case when there are still valuable teaching points on the last one.

A fellow planning on doing telerad needs to get his or her numbers up, and that’s not just about reading a lot of cases to gain experience and confidence (although that will happen in the process). Rather, the telerad attendings will show their fellows “how I do it.” That includes all of the tricks they have learned. This includes using keyboard shortcuts and voice commands, programming mouse buttons, arranging PACS toolbars, setting preferences, etc. Of course, this training would also include making the best use of all the tools offered by voice recognition software: macros within macros, templates, autocorrect features, etc.

Left to their own devices, new graduates going into telerad might take years to figure out all of this on their own. Even then, there might be tricks they have never encountered. A couple of decades in, they might feel too set in their ways to take on new habits. However, if you showcase all of this information while they’re still at the beginning of their careers, especially during rotations with a dozen different attendings who each have their own proven methods (and anecdotes to share from their previous telerad gigs complete with cautionary tales), you are giving the fellows access to a complete arsenal of “best practices.”

A teleradiology fellowship that offers an information technology (IT) component and dedicated time with teleradiology attendings to learn tricks of the trade with workstation navigation could go a long way toward reducing downtime and maximizing efficiency.

Exploring the Merits of a Teleradiology Fellowship, Part 2

's Weekly Scan is your chance to catch up on the latest radiology content, from new research and device news to the latest case quizzes and conference reports. Review the slideshow below to see this week's top content:

Diagnostic Imaging's Weekly Scan: September 18-September 24

Catch up on the top radiology content of the past week.

In order to reflect the most recent research on the use of computed tomography (CT) in cardiovascular imaging, the Society of Cardiovascular Computed Tomography (SCCT), the American College of Radiology (ACR), the North America Society of Cardiovascular Imaging (NASCI) and the American College of Cardiology (ACC) have unveiled an updated Coronary Artery Disease Reporting and Data System (CAD-RADS), also referred to as CAD-RADS™ 2.0.

, include an emphasis on the reporting of coronary plaque burden and ischemia findings on coronary CT angiography (CCTA). Here are five takeaways from the consensus recommendations.

1. Acknowledging emerging techniques for assessing CCTA and physiologic aspects of decision making with respect to coronary revascularization, the consensus panel recommended an “I” modifier to indicate testing for ischemia via computed tomography fractional flow reserve (CT-FFR) or stress computed tomography perfusion (Stress-CTP).

2. The consensus panel noted multiple benefits of utilizing stress myocardial CTP. In addition to enabling radiologists to discern fixed perfusion effects due to prior myocardial infarction (MI), stress myocardial CTP can prevent downstream testing by allowing radiologists to potentially exclude myocardial ischemia in cases of moderate coronary stenosis or severe coronary stenosis in the presence of mixed or densely calcified plaque.

In regard to stress CTP interpretation, the consensus authors recommended an “I+” modifier to denote myocardial ischemia or peri-infarct ischemia. An “I-” modifier could be employed when there is no detected ischemia, a previously fixed myocardial infarct or an ischemic segment that does not have a concordant anatomic lesion, according to the consensus panel. When there are indeterminate or questionable findings, or a high likelihood of false-positive results with stress CTP, the consensus authors recommended a “I=/-” modifier.

3. Noting recent research that has suggested a link between characteristics of high-risk plaque (previously referred to as vulnerable plaque) viewed on CCTA and acute coronary syndrome (ACS), the consensus authors said there is a need for a “HRP” modifier to denote high-risk plaque.

If CCTA reveals two or more high-risk plaque features, ranging from low attenuation plaque (less than 30 Hounsfield units) and positive remodeling to the “napkin ring sign” and spotty calcifications, the consensus panel suggested using the “HRP” modifier in these cases.

4. In order to reflect recent studies that have detailed a robust association between the coronary plaque amount found on CCTA and incident coronary heart disease, the consensus authors added the categories P1 to P4 to designate mild, moderate, severe and extensive coronary plaque. While reporting methods for coronary plaque burden assessment include qualitative visual estimates of plaque in coronary vessels, quantitative assessment of total coronary plaque, a segment involvement score (SIS) and coronary calcium (CAC) testing, the consensus authors maintained that CAC and SIS may provide more reproducible approaches for categorizing the amount of coronary plaque.

5. While non-atherosclerotic etiologies of coronary abnormalities, such as anomalous coronary arteries or coronary artery aneurysms, can be key considerations in a differential diagnosis, the consensus panel noted that CAD-RAD scores are commonly not utilized in these cases.

Accordingly, the consensus authors recommend using an “E” modifier to document exceptions in the form of non-atherosclerotic causes of coronary obstruction with CAD-RADS reporting. Not only could the E modifier aid in tracking these etiologies, it could also signal to referring clinicians that the case in question involves a coronary abnormality that may fall outside of the traditional CAD-RADS classification adherence to atherosclerotic coronary artery disease, according to the consensus panel.

In an update of the original CAD-RADS™ consensus document on coronary artery disease (CAD) imaging and reporting published in 2016, expert panelists incorporated emerging evidence for CAD-RADS 2.0 to recommend new categorization for coronary plaque burden and suggested modifiers to reflect the level of ischemia and high-risk plaque in patients undergoing cardiac computed tomography.

Five Takeaways from New Consensus Recommendations for CT Imaging and Reporting in Patients with CAD

The Food and Drug Administration (FDA) has granted 510(k) clearance to QT Imaging’s ultrasound-based device QTscan for fibroglandular volume calculations that can help clinicians assess the effectiveness of non-surgical breast cancer treatment.

In addition to aiding in the assessment of breast cancer risk, QT Imaging said the 

ability of QTscan to calculate the ratio of fibroglandular volume to total breast volume

 enables radiologists to gauge the progress of non-surgical therapies for patients undergoing treatment for breast cancer. One can also utilize the fibroglandular volume ratio to monitor the use of selective hormone receptor modulation treatment, according to the company.

QT Imaging emphasized that the QTscan is the first ultrasound-based modality to receive FDA clearance for the quantification of fibroglandular volume.

Elaine Iuanow, M.D., a breast imaging specialist, said the calculation of fibroglandular volume with QTscan is an “exciting” advance for the imaging and treatment of breast care patients.

“The ability to determine a therapeutic clinical response using a quantitative volumetric method is crucial for effective and timely treatment of breast cancer and for patients at high risk for developing breast cancer who are receiving hormonal therapy,” noted Dr. Iuanow, a consultant for QT Imaging.

Offering a combination of transmission ultrasound and reflection ultrasound, the QTscan provides “highly accurate” 3D imaging of breast tissue, according to QT Imaging. The company maintained the lack of radiation or compression with the QTscan device allows for more frequent monitoring of adjuvant chemotherapy or radiation therapy in the treatment of breast cancer.

The ability of QT Imaging’s QTscan, a quantitative transmission ultrasound modality, to calculate the ratio of fibroglandular volume to total breast volume may facilitate assessment of ongoing breast cancer treatments or selective hormone receptor modulation therapies.