Siemens Healthineers has announced FDA clearance of its Biograph Vision Quadra PET/CT
Molecular imaging current events recap
June 14, 2021
by Gus Iversen
, Editor in Chief
HCB News (www.dotmed.com/news) is a leading resource for nuclear medicine and molecular imaging current events. In this section we recap some of the most impactful stories we’ve covered over the last several months. For more stories like these, visit our news site and click “Molecular Imaging” in the red navigation bar at the top of the screen. Registering for our online news is completely free.
US lawmakers call CMS radiopharmaceutical payment policy 'flawed'
U.S. Representatives Scott Peters (D.-CA) and Bobby Rush (D.-IL) called out CMS in April for what they say is a “flawed” Medicare reimbursement policy for the use of diagnostic imaging drugs.
The two have requested a meeting to discuss the policy, which treats diagnostic pharmaceuticals as “ancillary” to imaging procedures in hospitals. This, they say, has led to drug costs being “policy packaged” into the procedure amount, which causes the price of the drugs to exceed the cost of the packaged procedure itself.
“The flawed reimbursement policy utilized by the Centers for Medicare and Medicaid Services threatens patient access to these cutting-edge innovations by creating a disincentive for hospitals to use the most appropriate diagnostic drugs,” the two wrote in a letter this month to CMS.
MITA also hosted a meeting last month on the issue. “This ongoing problem undermines public health and incentivizes the use of less effective screening modalities,” said event master of ceremonies Michael Guastella, executive director of the Council on Radionuclides and Radiopharmaceuticals Inc. (CORAR), at the start of the meeting.
CMS had the chance to unpackage the drugs as part of its final payment rule issued in 2020, but decided against it, despite the advice of its advisory committee and imaging stakeholders, wrote Peters and Rush, who are requesting a meeting to change the policy “in light of the adverse impact on beneficiary access and care.”
RaySearch to distribute Canon CT and PET/CT solutions in the U.S.
Canon Medical Systems USA announced in April that it would distribute its Aquilion Large Bore CT and Celestion PET/CT solutions through RaySearch Laboratories’ U.S. sales force.
The agreement builds on an existing partnership between the two, focused on offering U.S. providers an integrated radiation oncology portfolio that creates more efficient workflows for finding optimal cancer treatment plans.
The Aquilion Large Bore CT offers the largest bore opening at 90 cm; a 70 cm field-of-view; and an 85 cm extended field of view. It weighs 660 lbs, which enables it to scan larger patients, and utilizes Adaptive Iterative Dose Reduction 3D (AIDR 3D) technology to automatically reduce radiation dosage while maintaining spatial resolution and image texture.
Equipped with a 90 cm CT bore as well, the Celestion PET/CT is designed to support the simulation of radiation treatment planning. It can extend its field of view from 70 cm to 85 cm and uses Canon’s SEMAR technology to reduce metallic artifacts and improve visualization of implants and adjacent soft tissues for clearer and more confident diagnosis.
In 2018, Canon and RaySearch struck up a collaboration to offer Canon’s imaging systems with RayStation, RaySearch’s treatment planning solution. Together, the solutions provide clinicians with information needed to develop treatment plans, including the size and location of the tumor, the direction of radiotherapy beams and appropriate isocenter locations.
IBA teams with NorthStar to increase global access to Tc-99m
IBA announced a partnership with radiopharmaceutical developer NorthStar Medical Radioisotopes in March to make technetium-99m more globally available.
The two plan to help non-U.S. companies access NorthStar's Tc-99m generation systems, high tech separation platforms that process non-uranium based Mo-99 as a step in the production of Tc-99m. They are used in conjunction with IBA's electron beam accelerators for reliable commercial-scale production of Mo-99.
"Reliable access to technetium-99m, the most widely used diagnostic imaging radioisotope, is increasingly important as the world's population expands and ages, and the TCM Generation System can help to reliably address these unmet needs on a global basis," Stephen Merrick, president and chief executive officer of NorthStar, told HCB News.
IBA and NorthStar’s partnership builds on an existing contract under which NorthStar will use up to eight Rhodotron TT 300-HE electron beam accelerators developed by IBA for the production of non-uranium based Mo-99. It will then use this Mo-99 in its Tc-99m Generation System, RadioGenix to produce Tc-99m in the U.S. RadioGenix gained FDA clearance in 2018, making NorthStar the first U.S. source of Mo-99 in almost three decades.
The deal also comes amidst the near completion of NorthStar’s Accelerator Production facility expansion in Beloit, Wisconsin. The aim of the expansion is to create a sustainable, domestic Mo-99 supply in the U.S. through dual production and processing hubs for additional capacity and scheduling flexibility.
FDA clears Siemens whole-body PET/CT scanner
In March, Siemens Healthineers has announced FDA clearance of its Biograph Vision Quadra PET/CT scanner, which has an extended axial field of view (FoV) that allows for simultaneous whole-body imaging from top of head to thigh.
The scanner, which is designed for both clinical and research use, features a 106-centimeter axial FoV that is four times the PET axial FoV of the company’s Biograph Vision 600," said John Khoury, the U.S. vice president of Molecular Imaging at Siemens Healthineers North America. "The new scanner has the same 3.2-millmeter silicon photomultiplier (SiPM) detector technology and Time of Flight (ToF) performance, and the extended FoV allows clinicians to image all the vital organs simultaneously with higher sensitivity."
“This has the axial field of view of four Vision 600s,” Khoury told HCB News. “What this means is that clinicians can now observe organ-to-organ interaction.”
The large FoV allows clinicians to examine patient anatomy during radiopharmaceutical uptake in shorter periods of time and allows for radiation oncology planning for larger patients, Khoury said. Scans, particularly for pediatric patients, can also be done faster and at a potentially lower radiation dose. It also has applications in therapy research.
In Europe, where the Biograph Vision Quadra is already approved and in use since receiving a CE Mark last fall, clinicians are using the scanner for high throughput images, cut from 20 minutes to three to five minutes.
Eckert & Ziegler to open new production facility for radiopharmaceutical development
In February, German medical isotope producer Eckert & Ziegler added a new Current Good Manufacturing Practices (cGMP) production facility in the U.S. for contract manufacturing of radiopharmaceuticals.
The cGMP clean room suite is an expansion of its production side in Wilmington, Massachusetts, and will be a 21 CFR 211 compliant, radiopharmaceutical manufacturing facility for late stage investigational and commercial stage radiopharmaceuticals. The aim behind its establishment is to provide radiopharmaceutical development services to companies searching for U.S. and worldwide contract manufacturing.
“At the moment, a large number of radiopharmaceutical substances from international pharmaceutical companies are in advanced clinical trials, some of them for broad indications such as prostate cancer,” said Dr. Lutz Helmke, member of the executive board of Eckert & Ziegler AG and responsible for its medical segment, in a statement. “With the new cGMP facility, we offer both regional and global pharmaceutical companies a one-stop service for a variety of radio-pharmaceutical services under cGMP conditions.”
The company is completing a production facility at its Wilmington, Massachusetts site to produce yttrium-90 based radiopharmaceuticals to treat liver cancer, and plans to expand its European production capacity of Lutetium-177 labeled drugs to its U.S. site.
The new cGMP suite will enable it to offer complete early development services, including process development and scale-up, CMC manufacturing and packaging, product release and stability programs. Eckert & Ziegler will then be able to generate products on a clinical scale of phases I, II and III and for commercial use as a radiopharmaceutical contract manufacturer.
The facility will be operational by the end of 2021.
Spectrum Dynamics to proceed with lawsuit against GE over VERITON SPECT/CT
A jury trial was approved in February for Spectrum Dynamics to proceed in its case against GE Healthcare for alleged misappropriation of trade secrets.
GE stands accused of stealing trade secrets and ideas about Spectrum Dynamics’ VERITON, the first multipurpose, 12-detector SPECT system designed to provide 360-degree, full-body contour scanning to produce 3D coronary, bone and neuro images, and its VERITON-CT hybrid SPECT-CT system. The scanner facilitates broad-based transition from analog to digital within the SPECT imaging equipment market.
“By stealing Spectrum Dynamics’ inventions, GE avoided years of its own R&D efforts and considerable expense in an effort to hasten the development of its own directly competing device,” Michael Joos, president and CEO of Spectrum Dynamics, said in a statement when the suit was first filed. “GE sought a shortcut to a technology that its own engineers were unable to develop.”
Spectrum Dynamics claims that GE filed patents related to the technology and design of VERITON prior to its development and launch in June 2018. It says that in doing so GE created unfair competition, and is seeking to correct the label of “inventorship” on GE’s patents. It also is requesting monetary damages and both preliminary and permanent injunctive relief to prevent GE from continuing to develop, commercialize and use these trade secrets and ideas for any other purpose.
The lawsuit was filed in December 2018 in the U.S. District Court for the Southern District of New York. GE told HCB News at the time that it "observes and respects intellectual property rights, and denies these allegations."
Over 80% drop in SPECT-MPI had no impact on rate of abnormal findings
The University of Alabama Medical Center performed over 80% less SPECT myocardial perfusion imaging at the peak of the pandemic. A retrospective published in January, however, performed by researchers at the University of Alabama at Birmingham found that the decrease did not create any shift in the rate of abnormal SPECT-MPI findings.
"We hypothesized that due to the highly restricted availability of testing, only high-yield patients will undergo SPECT-MPI, while those expected to be normal would be delayed," the authors wrote. "However, we did not find any statistically or clinically significant increase in the rate of abnormal SPECT-MPI or that of myocardial ischemia during this period."
Exams like SPECT-MPI were postponed in accordance with guidelines issued by both the American Society of Nuclear Cardiology and the Society of Nuclear Medicine and Molecular Imaging during the pandemic, leading to significant restrictions.
Comparing the results of 210 patients who underwent SPECT-MPI in March and April 2020 to those of 1,106 who underwent the exam around the same time in 2019, the researchers found SPECT-MPI volumes at the hospital fell from 553 per month to 105, a decrease of 81%. The proportion of abnormal results, however, only dipped from 31% at the baseline to 27% at the peak.
"Significantly more studies were performed for symptom evaluation, and [fewer] studies were done for preoperative evaluation, which corresponded to a change in the referral pattern favoring studies referred by cardiology and primary care or internal medicine versus transplant services,” wrote the authors.
FDA gives nod to first PSMA-targeted PET tracer for prostate cancer
In December, the FDA approved the use of Gallium 68 PSMA-11 PET scans on patients with suspected prostate cancer metastasis or suspected prostate cancer recurrence.
“With this first approval of a PSMA-targeted PET imaging drug for men with prostate cancer, providers now have a new imaging approach to detect whether or not the cancer has spread to other parts of the body,” said Dr. Alex Gorovets, acting deputy director of the office of specialty medicine in FDA’s Center for Drug Evaluation and Research, in a statement.
The aim is to identify those who potentially could benefit from surgery or radiation therapy. The drug is administered as an intravenous injection that binds to the prostate-specific membrane antigen (PSMA), of which prostate cancer cells usually show high levels. It then emits positrons that the PET scan picks up on to show the presence of PSMA-positive cancer lesions in the tissues of the body.
With the drug, providers expect to be able to spare patients from unnecessary surgeries and locate biochemical evidence of recurrent prostate cancer that can help them prescribe the best course of treatment. It also is expected to overcome the limitations of CT, MR and bone scans in identifying prostate cancer lesions.
FDA approval was granted to the University of California, Los Angeles and the University of California, San Francisco.
A dossier for a cold kit 68Ga-PSMA has been filed by the company Telix Pharma and is awaiting approval from FDA at a national level and from the EMA at an EU level under the brand name, illumet, according to MEDraysintell.