The Food and Drug Administration (FDA) has approved an 

 that allows use of the gallium GA 68 gozetotide injection preparation kit for PSMA-guided PET imaging of metastatic prostate cancer to help determine whether patients are candidates for radioligand therapy.

In order for patients to be considered as viable candidates for targeted radioligand treatment, they need to undergo imaging with an approved gallium-based prostate-specific membrane antigen (PSMA) positron emission tomography (PET) agent, according to Telix Pharmaceuticals. The company added that Pluvicto

 (Novartis) is currently the only FDA-approved PSMA-directed radioligand treatment.

“As radioligand therapy for prostate cancer becomes more prevalent, it is critical for doctors to understand who may or may not respond to those treatments. There’s no doubt that appropriate selection of patients for PSMA-targeted radioligand therapy is dependent on appropriate imaging,” emphasized Oliver Sartor, M.D., a professor of medicine and the director of the Tulane Cancer Center at the Tulane University School of Medicine in New Orleans.

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

Recurrent Prostate Cancer and Low PSA Levels: Can an Emerging PSMA PET Agent Have an Impact?

Could an Emerging PSMA/PET Imaging Agent Improve the Detection of Recurrent Prostate Cancer?

Telix Pharmaceuticals said findings from the phase 3 VISION trial demonstrated the ability of Illuccix to aid in the detection of prostate cancer and help identify patients who may benefit from PSMA-based radioligand therapy.

“Ga-68 PSMA-11 PET was used in the VISION trial and, when used in combination with contrast-enhanced CT, represents a powerful tool for detecting prostate cancer and helping guide patient management,” noted Dr. Sartor, the lead author of the VISION study.

1. Telix Pharmaceuticals Limited. FDA approves expanded indication for Telix’s Illuccix® to include patient selection for PSMA-directed radioligand therapy. Cision PR Newswire. Available at: 

https://www.prnewswire.com/news-releases/fda-approves-expanded-indication-for-telixs-illuccix-to-include-patient-selection-for-psma-directed-radioligand-therapy-301773819.html

 . Published March 16, 2023. Accessed March 16, 2023.

2. Sartor O, de Bono J, Chi KN, et al. Lutetium-177-PSMA-617 for metastatic castration-resistant prostate cancer. 

Articles

The expanded indication could facilitate improved access to imaging for patients with metastatic prostate cancer who are candidates for radioligand treatment.

Illuccix Gets Expanded FDA Approval for Imaging of Metastatic Prostate Cancer

In a study involving over 2.5 million screening mammograms for over one million women, researchers found a significantly higher cancer detection rate and lower recall rate for digital breast tomosynthesis (DBT) in comparison to digital mammography (DM).

For the retrospective multicenter study, recently published in 

, researchers reviewed 2,528,063 screening mammograms for 1,100,447 women (mean age of 57). According to the study, 597,947 women had a total of 1,693,727 DBT screening exams and 502,500 women had a total of 834,336 DM screening exams.

The study authors found that DBT had a higher cancer detection rate (5.3/1000) in comparison to DM (4.5/1000) and a higher positive predictive value (5.9 percent vs. 4.3 percent). Researchers also noted a lower recall rate for DBT (8.9 percent vs. 10.3 percent for DM).

In a recent interview, Emily Conant, M.D., the lead author of the study, said the findings were similar to those noted in other studies of DBT but seeing the findings in a large, diverse multicenter cohort reaffirmed the advantages of DBT over two-dimensional (2D) mammography. She added that DBT also provides enhanced visualization for cancer detection in women with dense breasts.

“2D mammography, as we know, is very limited in (women with dense breasts) because the breast just appears white. That dense breast tissue obscures finding things,” noted Dr. Conant, the division chief of breast imaging and a professor of radiology at the Hospital of the University of Pennsylvania. “When you can scroll through these slices of reconstructed images of the breast, you can actually find things on (digital breast) tomosynthesis that you didn’t see on 2D mammography because it was just a white blizzard of breast density.”

Mammography Study Shows 22 Percent Higher Incidence of Dense Breasts in Women with a Family History of Breast Cancer

AI Improves Cancer Detection Rate for Digital Mammography and Digital Breast Tomosynthesis

FDA Issues Final Rule on National Breast Density Notification for Mammography Reports

For more insights from Dr. Conant, watch the video below.

Videos

In a recent video interview, Emily Conant, M.D., discussed findings from a large multicenter study highlighting the benefits of digital breast tomosynthesis (DBT) in breast cancer screening.

Large Mammography Study Reaffirms Benefits of Digital Breast Tomosynthesis

The Food and Drug Administration (FDA) has granted 510(k) clearance for the use of BoneView (Gleamer), an artificial intelligence (AI) software that helps detect fractures on X-ray, in patients over two years of age.

In a recently published study involving 300 pediatric patients, researchers demonstrated a 91.3 percent sensitivity rate and a 90 percent sensitivity rate for fracture detection.

Christian Allouche, the chief executive officer of Gleamer, called the 

pediatric clearance a significant advance

 in the company’s efforts to improve fracture detection and diagnosis through the use of AI.

Employing deep learning algorithms, the BoneView software analyzes X-rays and highlights regions of interest for suspected fractures that are sent to the radiologist for confirmation, according to Gleamer. The company said BoneView is the only AI fracture detection software to have FDA clearance for use in adults and pediatric patients.

BoneView 510(k) clearance in March 2022 for fracture detection in adults

The artificial intelligence (AI)-enabled software, which has a documented 91 percent sensitivity rate for detecting pediatric fractures, is reportedly the first AI fracture detection modality to receive FDA 510(k) clearance for use in the pediatric population.

Gleamer's BoneView Gains FDA Clearance for AI-Powered Pediatric Fracture Detection

Radiologists and emergency physicians may agree that structured or templated formats should be utilized to report actionable incidental findings (AIFs) in emergency departments (EDs). However, two-thirds of those surveyed said structured reporting is sometimes used or “almost never used” for incidental findings on ED imaging.

That is one of the findings that emerged from a recently convened 15-member panel, including members of the American College of Radiology (ACR) and the American College of Emergency Physicians (ACEP), to address best practice recommendations for the management of incidental imaging findings in EDs.

The panel sought to address the reporting of AIFs in EDs, communication of AIFs with clinicians, communication of AIFs with patients and systems for tracking follow-up, according to the recently published findings of the panel in the 

Journal of the American College of Radiology

. In order to achieve consensus, the panel members completed an anonymous survey, discussed the results, and proceeded with a second round of survey questions to address questions that did not have an initial consensus response.

1) The panel largely agreed that radiology reports involving AIFs should note the lesion size, location, and characteristics of the AIF; follow-up modality and time frame; any available evidence to support recommendations; documentation of notification or communication; and language geared toward patients. The panelists said the latter four elements should only be included in the summary section of the radiology report.

For the presence and recommended follow-up of an AIF, the panel unanimously agreed that written instructions should be given to the patient upon discharge from the facility and 93 percent of the panelists emphasized verbal communication between the emergency clinician and the patient as being “very important” regarding AIFs in the radiology report.

Managing Incidentalomas in Radiology: Embracing Challenges as Opportunities

3) However, the panelists noted a wide variability with current communication of AIFs to patients. Fifty-three percent of the panelists said written communication happened “some of the time and 73 percent claimed that clinicals “almost always” provided verbal communication of AIFs to patients.

4) Over 80 percent of the panelists, including five radiologists, said direct communication from the radiologist to the patient regarding AIF(s) was unnecessary.

5) In regard to follow-up communication, only 27 percent of the panelists said this “almost always” occurs in cases involving AIFs. However, in the second round of the survey, 94 percent of the panelists said “communication … at a later time from the facility where the imaging was obtained” was important or very important.

6) When radiologists detect an AIF, the panelists unanimously agreed they should “activate an alert or tracking system” in addition to noting the finding in the radiology report.

7) The panelists unanimously agreed that tracking systems should be in place at hospitals in order to provide specific tracking of communication about AIFs and help monitor for appropriate follow-up.

“Perhaps the most important area in which agreement was strong was that the communication of incidental findings is ultimately a systems responsibility as opposed to the responsibility of individual clinicians,” wrote study co-author Lauren Parks Nicola, M.D., the chief executive officer of Triad Radiology Associates in Winston Salem, N.C., and colleagues. “ … Although either a radiologist or an (emergency physician) could potentially flag reports, approaches that allow automated flagging through structured reporting or natural language processing may provide the most reliable capture.”

Noting that computed tomography (CT) scans are obtained for more than 30 million emergency department (ED) patients annually and that 31.3 percent of ED CT scans reveal incidental findings, representatives from the American College of Radiology (ACR) and the American College of Emergency Physicians (ACEP) recently collaborated on best practice recommendations for addressing incidental imaging findings in EDs.

Seven Takeaways from Best Practice Recommendations for Incidental Radiology Findings in the ER

Images 1 and 2

Review the case study and test your knowledge to make the correct diagnosis.

Image IQ Quiz: Middle-Aged Male with Epigastric Pain and Retching

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

I was recently asked to be a guest for a podcast (

 ). The invitation originally came around the holidays. During this time, we tried making a “Christmas pudding” with shades of Merrie Olde England. It was something of a production and for those unfamiliar, that ultimately included lighting the thing on fire. We captured that on video as well as my lady’s reaction to actually tasting the thing since she was convinced it would be comedically negative. (As it happened, she was pleasantly surprised until she had a minor allergic reaction.)

Watching the video before to posting it for friends and family to see, I was reminded that I really don’t like my recorded voice. I felt the need to comment that I sounded much better from inside my own head and began to wonder whether I might ultimately hate myself for agreeing to the podcast.

I went through with it and felt the recording treated me kindly. I have happily been able to sit through the entire playback without cringing. I definitely found myself wishing I had said one or two things differently, added something else, etc. However, that brings me to the topic of this week’s blog: Under the right circumstances, I have a nearly limitless capacity for editing my own work.

Those “right circumstances” include having sufficient time and perceived importance of whatever I am editing. This blog is a good example. Once upon a time, when I was working a seven days on, seven days off telerad job, I had a solid week in which to write upcoming blogs. I would typically get a chunk of the pieces done in the first day or two, and then revisit them for multiple sessions of tweaking. Sometimes it amazed me how much I kept on finding to change.

Elsewhere, if I found myself with only a day or two to get everything done, I found a way to accomplish the same thing. Sometimes, things felt a little less polished but there have been more than a couple of blogs that I have felt great about after a single session at the keyboard. It has occurred to me that my propensity for editing is akin to a goldfish’s ability to grow to the size of its environment. (By the way, that isn’t quite as straightforward as it might seem. I looked that up to check the veracity.)

Knowing just how much time I can spend improving a piece, I have tried making a habit of never sending an email or other written communication without at least double-checking it, and preferably setting it aside to review later. Otherwise, it is amazing to see what can slip through the cracks. I try not to let that keep me up at nights given the substantial volumes of radiology reporting I have to sign.

What They Didn’t Tell You About Voice Recognition Software

Why Being a Situational ‘Completionist’ is Perfect for Modern Radiology

Thinking about it, though, one of these blogs comes out to a page or two on my word processor. Compare just a few hours in a week spent on the blog versus churning out 100-plus radiology reports in a workday (and a 

 more cases than that in some previous jobs). A few minutes spent with my eyes more on the images than my voice recognition screen just can’t compare. What kind of drivel am I electronically signing my name to?

Like a goldfish confined to a small bowl, though, I really don’t have a viable choice. Once upon a time, when rads read a fraction of what they do now, it was another story. We’d sit down after the transcriptionists had gotten through a chunk of our caseload and review our reports before signing them. There were two sets of human eyes to screen out nonsense or poor word choices.

That addresses the time factor, but I also mentioned “perceived importance” of my editing subject matter. In these blogs, or in other writing like a letter to my accountant in tax season, I really want every statement to land the right way. Otherwise, there are consequences or, at the very least, embarrassment when I see that something I said sounded dumb or was frankly wrong.

What’s important in a radiology dictation? There is a lot of unimportant verbiage we have to include, which dilutes (sometimes drowns) the key stuff. This may be technical factors nobody cares about, hedges and disclaimers as well as government- or department-mandated boilerplate info. We can take care of a lot of that with automatic templates, but not all of it. If something incorrect or ungainly finds its way into this word salad, is anybody going to care?

Once upon a time, I cared a lot more about sounding good. If my reports contained grammatical errors, for instance, colleagues, referrers, or patients might think less of me.

I haven’t stamped out that motivation entirely, but it’s been beaten down quite a bit. How could it not? Most of the cases I receive have nothing resembling a scholarly (or even coherent) clinical history. I routinely get calls for clarifications or addenda indicating that whoever is reading my reports isn’t exactly an appreciative audience for the finer nuances of language. Heck, I consider myself fortunate when it turns out that they have a basic understanding of the medical issues at hand. “Pearls before swine” is too harsh an expression, but at the moment I can’t think of anything more charitable.

It also doesn’t help that, even when I was still making greater editorial efforts for my rad reports, I found that the voice recognition software was constantly working against me. The machinery tirelessly inserts the wrong words/phrases, messes around with pluralization, and otherwise does things its programmers evidently thought would be helpful.

“Tireless,” however, did not describe me as I gradually gave up trying to retrain the machine and manually fix all of its stupid blunders. At some point, I started letting some of its nonsense go when it’s clear that none of the important interpretive findings were being obscured. I have other things on which to expend my energy, emotional and otherwise.

In an age of robust imaging volume, time constraints and challenges with voice recognition software, attention to detail with verbiage in radiology reports may suffer.

How Rigorous is Your Self-Editing of Radiology Reports?

In a study of over one million Korean women, researchers found a significantly higher likelihood of increased breast density or persistent dense breasts for women who had a family history of breast cancer (FHBC).

For the retrospective study, published recently in 

, researchers reviewed data from a national insurance database of 1,174,214 premenopausal women (mean age of 46.3). The study authors noted that 34,003 women acknowledged first-degree relatives with a history of breast cancer.

Women with FHBC were 22 percent more likely to have dense breasts in comparison to women without FHBC, according to the study findings. When there was breast cancer history for a mother and a sister, the researchers found that women were 64 more likely to have dense breasts. The study authors noted that having a mother with breast cancer was associated with a 15 percent higher likelihood of dense breasts and having a sister with breast cancer was associated with a 26 percent higher likelihood of dense breasts.

“Our findings highlight that FHBC is an important risk factor for breast cancer; it is also associated with breast density and its increment or persistent density over time, suggesting aggregation of hereditary risk factors of breast cancer,” wrote Boyoung Park, M.D., Ph.D., who is affiliated with the Department of Preventive Medicine at the Hanyang University College of Medicine in Seoul, Korea, and colleagues.

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

DA Issues Final Rule on National Breast Density Notification for Mammography Reports

Current Insights on National Breast Density Notification for Mammography Reports

Interval Breast Cancer: What a New Mammography Study Reveals

For women with FHBC and fatty breasts at an initial screening in the study, the researchers noted a 19 percent higher likelihood of developing dense breasts in comparison to women without FHBC. Park and colleagues also noted that women with FHBC were 11 percent more likely than women without FHBC to develop persistently dense breasts.

In regard to study limitations, the study authors acknowledged a lack of information in the cohort database on age at the time of breast cancer onset, the affected relative and first- or second-degree relatives, factors that can impact the association between breast density and family history of breast cancer. They noted the potential for recall bias with the family history of breast cancer being self-reported. Pointing out that women in the study could have had yearly or biennial breast cancer screening, the researchers assessed breast density changes within a two-year period.

Newly published retrospective research involving a large database of premenopausal women in Korea showed that women were 64 percent more likely to have dense breasts if their mother and a sister had breast cancer.

Noting the prevalence of dense breasts in approximately 40 percent of women in the United States, their increased risk for breast cancer and the inconsistency of state laws on breast density notification, Wendie Berg, M.D., Ph.D., said 

implementation of a national standard for breast density notification (to begin on September 10, 2024)

In a recent video interview, Dr. Berg said the patient breast density notification language in the recently issued final rule updates from the Food and Drug Administration (FDA) to the Mammography Quality Standards ACT (MQSA) emphasizes direct communication as to whether a woman has dense breasts or not, touches upon the limitation of mammography for women with dense breasts and encourages supplemental screening in this patient population. With the FDA requiring this language in all mammography reports as of September 10, 2014, Dr. Berg says there will be a level of consistency with breast density notification that has not been there with varying state laws in 38 states and the District of Columbia.

“What this does is establish a bare minimum of communication that is uniform across all states no matter where a woman lives, which is certainly desirable to reduce confusion,” noted Dr. Berg, a co-founder and chief scientific advisor for 

New Meta-Analysis Says MRI is Best Supplemental Imaging for Dense Breasts

What a New Study Reveals About Breast Density Awareness

As patients become more educated on the elevated breast cancer risks with dense breasts and seek out supplemental imaging options, Dr. Berg said the education of referring providers is paramount to help ensure optimal outcomes.

“I think that has been an area where there has been a relative gap,” maintained Dr. Berg, a professor of radiology at the University of Pittsburgh School of Medicine. “It’s never really clear who is taking the time to explain all these issues to patients. I think radiologists actually can serve a primary role in large part in helping to educate. If they don’t educate the patient directly, they can at least educate their referring physicians about the options and issues with risk assessment and breast density.”

For more insights from Dr. Berg, watch the video below.

In a recent video interview, Wendie Berg, M.D., Ph.D., discussed the newly issued final rule from the Food and Drug Administration (FDA) requiring a national standard for breast density notification (starting on September 10, 2024) as well as its potential impact in mammography reporting and facilitating supplemental screening for patients with dense breasts.



'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: March 5-March 11

Slideshows

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

The days of inconsistent breast density notification for mammography reporting are coming to an end.

newly issued final rule updates to the Mammography Quality Standards Act (MQSA)

, the Food and Drug Administration (FDA) will require standard breast density notification in mammography reports, beginning on September 10, 2024, for all women in the United States.

In addition to requiring notification in the patient summary of mammography reports as to whether a patient has dense or not dense breasts, the FDA rule requires standard language that will note the limitations of mammography for women with dense breasts and encourage supplemental screening.

For women with dense breasts, the FDA said the standard breast density notification language will be as follows: “Breast tissue can be either dense or not dense. Dense tissue makes it harder to find breast cancer on a mammogram and also raises the risk of developing breast cancer. Your breast tissue is dense. In some people with dense tissue, other imaging tests in addition to a mammogram may help find cancers. Talk to your healthcare provider about breast density, risks for breast cancer, and your individual situation.”

JoAnn Pushkin, the executive director for DenseBreast-info.org, said the national standard for breast density notification is essential. While 38 states and the District of Columbia currently have breast density information laws, Pushkin said the state laws vary considerably and some don’t require specific notification to women that they have dense breasts. Pushkin maintained that the inconsistency of “state-by-state geography-dependent notification has created an inequity of actionable information for women.”

“All U.S. women should receive clear, unambiguous notification if their breasts are dense — and that having dense breasts increases both (their) risk of developing breast cancer and of having that cancer missed on (their) mammogram, and that (they) should talk to (their) health provider about supplemental screening,” emphasized Pushkin.

Mammography News: FDA Says National Breast Density Notification Rule May be Published in Late 2022 or Early 2023

Can AI Improve the Consistency of Breast Density Assessment by Radiologists?

In a recent interview (see video clip below), Wendie Berg, M.D., Ph.D., said “it has been a long time coming” for a national standard for breast density notification to help address a common problem and a well-known limitation of mammography. Approximately 40 percent of women have dense breasts and nearly 40 percent of breast cancer is hidden in dense breast tissue, emphasized Dr. Berg, a professor of radiology at the University of Pittsburgh School of Medicine.

Dr. Berg noted magnetic resonance imaging is the best supplemental imaging “by far” and noted that abbreviated MRI is becoming more available and less expensive. She noted there are now over 100 facilities in the U.S. that offer abbreviated MRI.

In addition to changes in the patient summary of mammography reports, Dr. Berg said the new FDA rule will require radiologists to note one of the four breast density categories in the American College of Radiology’s Breast Imaging Reporting and Data System (BI-RADS) when detailing breast density assessments to referring providers. While she noted that many facilities are already doing this, Dr. Berg said it is only a strong recommendation to include this categorization in mammography reports at the present time.

Calling the FDA final rule on breast density notification a reasonable step forward, Dr. Berg also emphasized that more education and awareness of breast density is needed for referring providers in terms of understanding the limitations of mammography in this patient population, supplemental screening options and where breast density fits in with other risk factors for breast cancer.

As part of updates to the Mammography Quality Standards Act (MQSA) of 1992, the Food and Drug Administration (FDA) has issued a final rule that requires the inclusion of breast density assessment in mammography reports starting on September 10, 2024.