The Case for 18F-NaF PET/CT Bone Metastases Detection

Results from the MITNEC-A1 trial are in, and they further support using 18F-NaF PET/CT to detect bone metastases in patients with prostate and breast cancer, while bolstering its case for replacing 99mTc-MDP as the “bone imaging radiopharmaceutical of choice.”

The prospective, multicenter, single-cohort, phase 3 trial enrolled 261 breast and prostate cancer patients (57 & 204) who had high risk or suspected bone metastasis, scanning each participant with 18F-NaF PET/CT and 99mTc-MDP SPECT. 

Two experts interpreted the scans, which were later compared to 24-month follow-up results, revealing that 42% of the patients had bone metastases (109), and finding that 18F-NaF PET/CT diagnosed bone metastases with far higher…

  • Accuracy – 84.3% vs. 77.4%
  • Sensitivity – 78.9% vs. 63.3%
  • Negative Predictive Value – 85.4% vs. 76.9%

The MITNEC-A1 trial stands on the shoulders of a growing list of studies that support 18F-NaF PET/CT for bone metastases detection, and these latest results make the transition to 18F-NaF PET/CT “appealing” to this study’s authors. 

The next step in that transition process will likely be exploring 18F-NaF PET/CT’s cost-effectiveness versus bone scintigraphy with 99mTc-MDP SPECT, potentially leading to more widespread adoption.

The Takeaway

It’s historically been a challenge to detect prostate and breast cancer bone metastases. Although there’s more research to be done, it appears that 18F-NaF PET/CT might help overcome that challenge, and become bone imaging’s new radiopharmaceutical of choice.

GE Healthcare Launches All-Digital Omni Legend PET/CT

GE Healthcare announced a major update to its molecular imaging lineup, launching the all-digital Omni Legend PET/CT.

The FDA-cleared and CE-marked Omni Legend is the first product to launch from GE’s new Omni PET/CT platform, and leverages an array of new technologies that drive big improvements to image quality, workflow efficiency, clinical versatility, and precision medicine. 

  • dBGO Detector – The Omni Legend is highlighted by its new digital BGO detector (dBGO), which provides 2.2-times higher sensitivity, 16% to 20% improved small lesion detection, and 53% faster PET scans.
  • Precision DL – GE’s new Precision DL software expands the Omni Legend’s support for tracers “beyond FDG” (using image processing) and enhances image quality (using deep learning image reconstruction).
  • Clinical Versatility – The above combination of sensitivity, image quality, and tracer compatibility allows the Omni Legend PET/CT to support a wider range of oncology, cardiac, and neuro use cases, in addition to supporting the diagnostics role within theranostics.
  • Efficiency Forward – In addition to faster scan times, the Omni Legend supports GE’s efficiency solutions that streamline calibration (data quality assurance), simplify protocol selection (new UI), and reduce labor for patient positioning (AI-based Auto Positioning Camera).
  • Future Ready – Like GE’s other recent advanced imaging launches, the Omni platform is built to support future upgrades, covering all core dimensions of PET/CT imaging (axial FOV, detector, software, CT, tracers, etc.).

The Takeaway

A completely new PET/CT platform doesn’t come along very often, and GE Healthcare seems to have made the most of this rare occasion with Omni PET/CT, bringing many improvements that imaging teams are seeking today, along with the theranostics support and component upgradability that should pay off in the future.

SubtlePET Validations

Two new studies out of France added to the growing field of evidence supporting Subtle Medical’s SubtlePET solution, with each confirming that it allows shorter-duration PET exams without affecting image quality. 

The first study, published in EJNMMI Physics, proclaimed SubtlePET “ready to be used in clinical practice for half-time or half-dose acquisitions” after it restored 18F-FDG PET/CT exams from three different scanners without impacting diagnostic confidence.

The researchers performed 18F-FDG PET/CT exams on 110 patients, producing full-acquisition, 50%-reduced, and 66%-reduced images (PET100, PET50, and PET33). They then denoised the images with SubtlePET and had two senior nuclear physicians evaluate them, finding that SubtlePET improved:

  • PET33 image quality from 16.7% to 86.7% “interpretable” & 0% to 26.7% “good”
  • PET50 image quality from 83.6% to 100% “interpretable” & 1.8% to 84.5% “good”
  • High-BMI patients’ PET100 exams from 60% to 80% “good” image quality (both were 100% interpretable)

The second study out of France’s Baclesse Cancer Center further confirmed that SubtlePET preserves 18F-FDG PET image quality with half-duration exams. 

The researchers performed 90-second and 45-second 18F-FDG PET/CT exams on 195 patients (PET90 & PET45), and then used SubtlePET to denoise the 45-second images, finding that:  

  • PET45 exams produced mediocre image quality (8% poor, 68% moderate) and achieved an 88.7% lesion concordance rate with PET90
  • After SubtlePET enhancement, PET45’s image quality matched PET90 (both 92% good, 8% moderate) and achieved a 97.7% lesion concordance rate with PET90
  • 7 of the discordant lesions (0.8%) were only detected with PET90 and 13 (1.5%) were exclusively detected with SubtlePET-enhanced PET45 images

The Takeaway
May was a particularly big research month, but SubtlePET has been on an academic hot streak for over a year, including at least three previous studies validating its performance with lower radiotracer dosage and faster acquisition times.

Subtle Medical’s marketing currently appears to focus on SubtlePET’s support for shorter scans, but it’s easy to see how patients and clinicians would welcome both shorter scans and lower radiotracer dosage, and the research increasingly seems to validate both use cases.

BAMF & United Imaging’s Precision Medicine Milestone

BAMF Health took a big step in its precision medicine strategy, installing United Imaging’s uEXPLORER total-body PET/CT scanner as it prepares to open its theranostics treatment center. 

Founded in 2018, BAMF Health (Bold Advanced Medical Future) has applied a unique approach to developing advanced treatments, combining the world’s “most advanced” radiopharmacy, its proprietary AI platform, and top molecular imaging technology to deliver hyper-personalized and targeted treatments.

Installing United Imaging’s uEXPLORER total-body PET/CT scanner represents a key final addition to BAMF Health’s precision medicine stack, and makes it the first institution in the US using total-body PET for theranostics. More importantly, the uEXPLORER will allow BAMF Health to deliver more effective and efficient theranostics treatments by:

  • Imaging patients’ entire bodies in a single scan (vs. “eyes to thighs”)
  • Detecting and targeting signs of cancer smaller than two millimeters (vs. 1 cm)
  • Scanning patients in just one minute (vs. up to 1hr)
  • Reducing radiation dosage by up to 40x

BAMF Health’s launch might also represent an early theranostics paradigm shift, highlighting the potential role of private clinics (vs. academic/large institutions) and total-body PET/CT systems (vs. “whole”) with the advanced therapy.

BAMF Health will begin treating patients for prostate cancer and neuroendocrine tumors at its Michigan-based clinic this summer, but plans to deliver a wide range of personalized treatments that extend well beyond cancer in the future (e.g. Alzheimer’s, Parkinson’s, cardiac diseases, endometriosis, chronic pain) and treat patients from around the country.

The Takeaway

Although BAMF Health still has a lot to prove, its upcoming clinical launch might be a key milestone in the evolution of theranostics and molecular imaging.

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