CT Lung Screening’s Weak Link

CT lung cancer screening rates in the U.S. remain abysmally low, over a decade after the exam was recommended. Is part of lung screening’s problem its reliance on provider referrals? A new research letter in JAMA Network Open examines this question. 

Unlike breast screening, in which eligible women are able to self-refer themselves for exams, CT lung screening revolves around provider referrals to start the process. 

  • CMS requires a shared decision-making session that results in a written order from a practitioner for a CT lung screening exam in order to pay for screening through Medicare and Medicaid. 

When CMS created the rules in 2015, provider referrals and shared decision-making were seen as ways to get patients involved in their own care by making choices in coordination with their caregivers.

  • But many are starting to see the requirements as a barrier, especially given low CT lung screening rates in the U.S.

In the new article, researchers investigated how easy it would be for an eligible individual to secure a CT lung screening appointment by just calling hospitals – without a provider referral. 

  • They note that one-third of Americans don’t have primary care clinicians, and are often told to call hospitals directly to set up appointments.

So they did just that, placing phone calls to 527 hospitals asking to arrange CT lung screening appointments, finding …

  • 317 calls (60%) failed because the caller did not have a primary care provider’s order.
  • Only 51 hospitals (9.7%) were able to connect callers to any component of a lung cancer screening process. 

The study authors note that the provider referral requirement isn’t the only thing holding CT lung cancer screening back, as even patients with primary care providers aren’t getting screened, and managing nodule follow-up can also be challenging. 

  • But Medicare’s cumbersome reimbursement rules certainly don’t help bring new people into the fold.

The Takeaway

Given CT lung cancer screening’s undisputed life-saving value, there’s no reason to put unnecessary barriers in its way. The provider referral and shared decision-making requirements are lung screening’s weak link to securing greater adoption, and CMS should rescind them to put CT lung cancer screening on the path to greater adoption.

FFR-CT Reduces Invasive Angiography Rates

Performing automated CT-derived fractional flow reserve with Shukun Technology’s software reduced referrals to invasive coronary angiography by 19% in a new study in Radiology. The findings suggest that software-based FFR-CT can serve a gatekeeper role in managing workup of patients with suspected coronary artery disease. 

Cardiac CT has been a revolutionary tool for assessing people with heart problems, evolving rapidly into a first-line modality that’s eclipsed other more traditional imaging technologies. 

  • But CCTA’s prowess also has a downside – more referrals to invasive coronary angiography, in some cases for patients without obstructive disease.

Rising to this challenge is FFR-CT, which uses automated software to calculate maximum blood flow in the coronary arteries and detect dangerous coronary lesions that could be early signs of a cardiac event. 

  • The segment to date has been dominated by HeartFlow, thanks to its early start in the field: its FFRCT software got FDA clearance in 2014 and the company has used its dominance to build a massive cash position.

In the new China CT-FFR Study 3, researchers in China used another FFR-CT application, Shukun’s skCT-FFR, and compared angio referral rates for 5.3k patients with suspected coronary artery disease who were scanned with either CCTA alone or CCTA and FFR-CT. They found …

  • Referral rates were lower for those who got FFR-CT (10% vs. 12.4%), a 19% relative difference.
  • Fewer cardiac events occurred in the FFR-CT group at one year (0.5% vs. 1.1%).
  • There was no statistically significant difference in major adverse cardiac event rates at 90 days (0.5% vs. 0.8%, p=0.12) and one year (2.9% vs. 2.8%, p=0.9).

Shukun is not as well known in the West as other developers of FFR-CT software like HeartFlow, but the company has raised over $250M to date – enough to land it in the top echelon of AI developers. 

  • One advantage of Shukun that was evident with the new study is that image processing was performed on-site, rather than being shipped off-site as is the case with other applications. 

The Takeaway

The study shows that FFR-CT can make cardiac CT more precise while tamping down on referrals to invasive angiography that have come from growing CT use. The results should also help put Shukun on the radar of many industry observers in a segment that so far has been dominated by HeartFlow.

Did Malpractice Risk Kill V/Q Exams?

CT perfusion angiography exams have largely replaced nuclear medicine-based ventilation/perfusion (V/Q) studies for detecting pulmonary embolism. But a new article in Academic Radiology suggests that CT’s rise wasn’t entirely based on clinical efficacy – fears of malpractice risk may have played a role. 

V/Q studies can help diagnose PE by enabling clinicians to visualize lung perfusion, showing defects such as blockages in pulmonary vessels. The scans are typically performed in three phases … 

  1. An albumin injection to show pulmonary vasculature.
  2. A radiopharmaceutical that’s inhaled and imaged with a gamma camera.
  3. A chest radiograph to correlate findings. 

The scans dominated PE imaging in the 1980s, but the rise of CT saw radiology facilities begin to shift.

  • CTPA was seen as having higher spatial resolution and was easier to perform than nuclear medicine exams. 

But the new article suggests that there were other forces at work as well – in particular, fear of malpractice risk from PEs that weren’t adequately followed after inconclusive V/Q exams.

  • The problem originated with clinical guidelines for V/Q reporting that classified some 20% of V/Q studies as “low probability” for PE when they probably would have better been classified as “inconclusive” or “non-diagnostic.”

As a result, a number of “low probability” patients weren’t followed up adequately, with tragic results that later figured into medical malpractice cases …

  • A patient who was diagnosed with pneumonia after an inconclusive V/Q exam, sent home, and died one day later of a “massive” PE.
  • A patient with leg and chest pain who was given heparin after a negative V/Q scan and later suffered internal hemorrhage; fortunately she survived.
  • A patient with “vague symptoms” who had an inconclusive V/Q scan and later died of an undiagnosed PE that some claimed would have been detected on CTPA.

Indeed, the theme of PE malpractice cases began to shift over time, from failure to diagnose V/Q scans to failure to order CTPA exams – which were soon seen as the clinical gold standard.

The Takeaway

Given the fast pace of development in radiology, it’s inevitable that some technologies that were once clinical staples fall by the wayside. But the new article offers a fascinating look at how clinical language can lead to medico-legal concerns that influence physician behavior – often in ways that are impossible to detect as they happen.

Low-Dose CT Confounds CAD in Kids

When it comes to pediatric CT scans, clinicians should make every effort to reduce dose as much as possible. But a new study in AJR indicates that lower CT radiation dose can affect the performance of software tools like computer-aided detection. 

Initiatives like the Image Wisely and Image Gently projects have succeeded in raising awareness of radiation dose and have helped radiologists find ways to reduce it.

But every little bit counts in pediatric dose reduction, especially given that one CT exam can raise the risk of developing cancer by 0.35%. 

  • Imaging tools like AI and CAD could help, but there have been few studies examining the performance of pulmonary CAD software developed for adults in analyzing scans of children.

To address that gap, researchers including radiologists from Cincinnati Children’s Hospital Medical Center investigated the performance of two open-source CAD algorithms trained on adults for detecting lung nodules in 73 patients with a mean age of 14.7 years. 

  • The algorithms included FlyerScan, a CAD developed by the authors, and MONAI, an open-source project for deep learning in medical imaging. 

Scans were acquired at standard-dose (mean effective dose=1.77 mSv) and low-dose (mean effective dose=0.32 mSv) levels, with the results showing that both algorithms turned in lower performance at lower radiation dose for nodules 3-30 mm … 

  • FlyerScan saw its sensitivity decline (77% vs. 67%) and detected fewer 3mm lung nodules (33 vs. 24).
  • MONAI also saw lower sensitivity (68% vs. 62%) and detected fewer 3mm lung nodules (16 vs. 13).
  • Reduced sensitivity was more pronounced for nodules less than 5 mm.

The findings should be taken with a grain of salt, as the open-source algorithms were not originally trained on pediatric data.

  • But the results do underscore the challenge in developing image analysis software optimized for pediatric applications.

The Takeaway

With respect to low radiation dose and high AI accuracy in CT scans of kids, radiologists may not be able to have their cake and eat it too – yet. More work will be needed before AI solutions developed for adults can be used in children.

AI Recon Cuts CT Radiation Dose

Artificial intelligence got its start in radiology as a tool to help medical image interpretation, but much of AI’s recent progress is in data reconstruction: improving images before radiologists even get to see them. Two new studies underscore the potential of AI-based reconstruction to reduce CT radiation dose while preserving image quality. 

Radiology vendors and clinicians have been remarkably successful in reducing CT radiation dose over the past two decades, but there’s always room for improvement. 

  • In addition to adjusting CT scanning protocols like tube voltage and current, data reconstruction protocols have been introduced to take images acquired at lower radiation levels and “boost” them to look like full-dose images. 

The arrival of AI and other deep learning-based technologies has turbocharged these efforts. 

They compared DLIR operating at high strength to GE’s older ASiR-V protocol in CCTA scans with lower tube voltage (80 kVp), finding that deep learning reconstruction led to …

  • 42% reduction in radiation dose (2.36 mSv vs. 4.07)
  • 13% reduction in contrast dose (50 mL vs. 58 mL).
  • Better signal- and contrast-to-noise ratios.
  • Higher image quality ratings.

In the second study, researchers from China including two employees of United Imaging Healthcare used a deep learning reconstruction algorithm to test ultralow-dose CT scans for coronary artery calcium scoring. 

  • They wanted to see if CAC scoring could be performed with lower tube voltage and current (80 kVp/20 mAs) and how the protocol compared to existing low-dose scans.

In tests with 156 patients, they found the ultralow-dose protocol produced …

  • Lower radiation dose (0.09 vs. 0.49 mSv).
  • No difference in CAC scoring or risk categorization. 
  • Higher contrast-to-noise ratio.

The Takeaway

AI-based data reconstruction gives radiologists the best of both worlds: lower radiation dose with better-quality images. These two new studies illustrate AI’s potential for lowering CT dose to previously unheard-of levels, with major benefits for patients.

Combo CT Screening Detects More Disease

A CT lung cancer screening program that also offered abdominal non-contrast CT scans detected a large number of abnormalities outside the lung in a population of people with smoking histories. The combined approach could offer a more efficient way to detect multiple pathologies in a single patient visit. 

CT lung cancer screening is gaining momentum globally, but clinicians and researchers continue to look for ways to make it more valuable. 

  • That’s a good thing, because smoking is a risk factor not just for lung cancer, but also other pathologies like abdominal aortic aneurysm (AAA) – so why not screen for those at the same time?

In a paper in European Urology, U.K. researchers describe their Yorkshire Kidney Screening Trial (YKST), which sought to detect kidney cancer by piggybacking on the county’s existing CT lung cancer screening program. 

  • Abdominal non-contrast CT exams were offered at the same time as thoracic CT lung screening scans to high-risk people who met the lung program’s screening criteria, namely aged 50-85 and more than 30 pack-years of smoking history. 

In all, 4k people accepted the offer to get additional abdominal CT scans, which had the following findings …

  • 64% of patients had normal findings, while another 20% had images that required additional review but no further action.
  • 5.3% had a new serious finding.
  • Serious findings were broken down as follows: renal stones ≥ 5 mm (3%), AAA (1.5%), renal mass/complex cysts (0.62%), kidney cancers (0.25%), and other cancers (0.25%).
  • It took 13 minutes of additional time to perform the abdominal CT scan.

Researchers said the prevalence of additional disease in YKST was within the range of other U.K. screening programs, such as for colorectal cancer (0.16-0.61%) and breast cancer (0.92%). 

  • The high prevalence of AAA was “unexpected,” especially since many AAA cases were found in people who aren’t covered by existing AAA screening programs. 

The Takeaway

As with recent research combining CT lung screening with coronary artery calcium (CAC) scoring, the new study shows that lung screening offers an opportunity to screen for more than just lung cancer. By detecting additional disease, combo screening has the potential to flip the script when it comes to screening’s cost-benefit ratio. 

Lung Screening’s Star Turn at WCLC 2024

The World Conference on Lung Cancer (WCLC) is underway in San Diego this week, and CT lung cancer screening has had a starring role at the meeting. The sessions come as lung screening continues to build momentum through 2024. 

Low-dose CT lung screening got the green light from the USPSTF over a decade ago, but screening rates are still mired in the single digits in many regions. 

  • The evidence backing LDCT’s life-saving value has been building, however, and around the world countries are launching national screening programs to counter the smoking epidemic, the leading cause of preventable cancer death worldwide.

Sessions at WCLC 2024 have highlighted this progress, with many speakers focusing on ways to boost screening compliance or use tools like AI to detect more lung cancers. 

Presentations on early lung cancer detection have included the following findings… 

  • Three years of lung screening starting in 2021 in Quebec produced a lung cancer detection rate of 1.6% in the first screening round, with 85% of cancers stage I or II.
  • Advanced practitioner nurses are being trained in Australia to assess pulmonary nodules to alleviate workforce challenges when the country’s national lung screening program starts in July 2025. 
  • Using Coreline Soft’s AVIEW algorithm to read baseline LDCT exams helped BioMILD researchers move to a triennial screening interval without missing cancers. 
  • The QUILS system for lung cancer quality assurance helped assess quality across multiple LDCT screening sites in Kentucky.
  • Over 10 years in which 2.3k patients were scanned, researchers found a 3.7% lung cancer detection rate and 100% survival for early-stage cancer.
  • Among 4.2k patients, those who got screened had more stage I-II disease (72% vs. 37%) and higher rates of surgery-only treatment (56% vs. 25%) at three years. 
  • Using PanCan criteria to manage suspicious lung nodules worked better than Lung-RADS in 4.5k people screened, with fewer workup referrals (2.8% vs. 7.4%) and better PPV for high-risk malignancy (48% vs. 18%).

The Takeaway

This is just a selection of the exciting research being presented at WCLC 2024. It seems evident that CT lung screening’s future as a mainstream cancer test is closer than ever.

When Follow-Up Falls Short for Lung Nodules

Making sure suspicious imaging findings are followed up appropriately is a key element in providing quality patient care. But a new study found that some suspicious findings aren’t being adequately tracked, especially when it comes to lung nodules. 

Lung nodules are commonly detected on chest CT exams, and are often found incidentally, when patients are being examined for other reasons. 

  • While most smaller nodules don’t represent a threat to patients, it’s important to work up the ones that could be clinically significant. 

In the new paper, Japanese researchers studied 10.5k initial chest CT reports at their institution from 2020 to 2023. 

  • They developed a natural language processing algorithm that analyzed free-text reports to see which ones recommended follow-up. 

They determined that 1.5k reports (14%) recommended additional imaging with exams like chest CT or PET/CT; they then calculated whether these follow-up exams were conducted within 400 days of the initial exam. Further analysis indicated … 

  • For 36% of exams (543) researchers could not confirm that follow-up imaging had taken place.
  • In a random sample of 42 of these patients, 40.5% (17) were not followed up appropriately. 
  • For these cases, either no imaging was documented or no reason was given for the lack of follow-up.

The researchers clarified that they found no evidence of false negatives (missed cancers), as that wasn’t a goal of their study. 

The Takeaway

The new findings indicate both the challenge and opportunity of follow-up management. While radiology must do better in tracking patients with suspicious findings, the study shows that software-based solutions could help, especially those that are automated to scan radiology reports and alert radiologists to cases that need their attention.

Two-for-One CT Screening Hits the Road

A new study takes CT screening on the road in rural Appalachia, showing how a mobile van outfitted with a CT scanner can screen at-risk individuals for both lung cancer and cardiovascular disease in one visit. 

Recent studies have demonstrated the effectiveness of CT lung cancer screening not only among the overall population, but particularly among disadvantaged communities with lower healthcare access. 

  • Such limited access is common in rural areas of Appalachia, which also have some of the highest rates of smoking and cardiovascular disease in the U.S.

Researchers from West Virginia University wanted to tackle two challenges at once with LUCAS, a mobile van outfitted with a CT scanner for lung cancer screening. 

  • They noted that CT lung scans can also be used to acquire data on coronary artery calcium (CAC), a known risk factor for cardiovascular disease. 

LUCAS was launched in September 2021, so WVU researchers analyzed data acquired for 526 low-dose CT screenings of high-risk people conducted through December 2022. 

  • They used the CT lung scans to calculate CAC scores based on Agatson criteria, in which a score of 101-400 indicates moderate risk of cardiovascular disease and >400 is classified as high risk; individuals with scores ≥100 should be referred to aspirin or statin therapy. 

They found that LUCAS scans revealed … 

  • Over 54% of patients had coronary calcification on LDCT scans
  • 31% of patients had CAC scores ≥100 
  • 14% had CAC scores ≥400
  • Elevated CAC scores correlated with lung cancer risk based on Lung-RADS scores as well as smoking history based on pack-years
  • Of the patients with CAC scores ≥1 and who weren’t already on statin or aspirin therapy, 6.2% started statins and 3.3% started aspirin

Despite the firm link between CAC scores and lung cancer risk, the researchers expressed disappointment that so few patients started prevention therapy like statins or aspirin after their exams.

  • Indeed, researchers noted that few patients from the study got additional cardiac testing or follow-up referrals for cardiovascular prevention after their screenings. 

The Takeaway

The new study not only confirms recent research showing that opportunistic screening can enhance the value of CT lung cancer scans, but also the role that lung exams can play in reducing healthcare disparities. On the down side, it shows that all the screening in the world won’t make a difference if patients don’t get appropriate follow-up. 

CT Colonography Breakthrough

In a major news development this week, CMS proposed to begin Medicare coverage of CT colonography screening – also known as virtual colonoscopy – starting in 2025. The move will give radiology an entree into another of the major cancer screening tests. 

CT colonography has been around for over 30 years as an imaging-based alternative to optical colonoscopy for colorectal cancer screening that produces a virtual fly-through of a patient’s colon that can detect pre-cancerous polyps.

  • CTC has a number of advantages over traditional colonoscopy: patients don’t need to be sedated, and there is lower risk of complications such as bowel perforation. 

But CTC has struggled to gain wider acceptance in the face of fierce resistance from gastroenterologists. 

  • Gastroenterologists typically prefer to steer their patients to optical colonoscopy for cancer screening rather than refer them out for imaging exams.

The USPSTF in 2016 added CT colonography to its list of recommended cancer screening exams. 

  • This led to a 50% jump in virtual colonoscopy exams performed for privately insured patients. 

But as anyone who follows the US healthcare system knows, Medicare is the big enchilada when it comes to reimbursement, and the gastroenterology community has successfully fought off efforts to secure broader payment.

  • This comes in spite of clinical studies showing CT colonography’s effectiveness, and even the widely reported case of President Barack Obama undergoing a CTC screening exam in 2010 as part of his annual physical because it didn’t require sedation.  

But enough ancient history, on to this week’s news. In a proposed rule for the 2025 HOPPS issued on July 10, CMS proposed the following:

  • Remove coverage for barium enema for colorectal cancer screening, as it “no longer meets modern clinical standards”
  • Add coverage for CT colonography, creating Ambulatory Payment Classification (APC) 74261 for CTC without contrast and 74262 for CTC with contrast
  • Reassign CPT code 74263 for CTC/VC from “not payable” to “payable” status 

The Takeaway

This week’s news is a huge win for radiology and indicates that gastroenterology’s stranglehold on colorectal cancer screening is finally beginning to crack. Imaging facilities should begin preparing to offer CT colonography as a less invasive option to optical colonoscopy for Medicare beneficiaries.

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