United Imaging Healthcare has received the FDA sign of approval to begin distributing its uEXPLORER total-body PET/CT scanner in the U.S.

It is the first system in the world that can create a 3D image of the entire human body at one time. Its formation is the result of a years-long dual effort by United Imaging Healthcare and the EXPLORER Consortium, run by Simon Cherry and Ramsey Badawi from the University of California, Davis.

“Once we install the scanner in mid-2019 we can serve our patients in the Sacramento region by giving them access to this new technology,” Cherry, a professor of biomedical engineering and radiology, told HCB News. “We had originally thought EXPLORER might primarily be used as a tool for research, but with FDA clearance EXPLORER can now have a much broader impact in our community and, we hope, across the nation.”

That impact is expected by Cherry and UIH to appear in a wide variety of fields, from improving diagnostics to tracking disease progression to studying new therapies. One current use, for instance, is the ability to better visualize cancer that has spread beyond a single tumor site. Researchers are also expecting it to be used to measure blood flow across the entire body, and to study inflammation and infections, as well as immunological and metabolic disorders.

The combination of CT and PET capabilities will enable clinicians to study the anatomy and the functioning relationship between tissues and organs within the body, with the scanner able to image a whole patient within 15 to 30 seconds. This saves a tremendous amount of time compared to conventional PET scanners which require 10 to 20 minutes as they image parts of the body, and reduces the chance of blurriness in images by requiring patients to only hold one breath during procedures.

Equipped with more than 560,000 detector elements and close to 54,000 light sensors and channels of electronics, uEXPLORER possesses 40 times greater sensitivity than current clinical PET/CT scanners, a quality that is expected to create longer lifespans for radiotracers and reduce the amount of dose needed.

"We expect both hospitals and imaging providers that handle a high volume of patients and those who are interested in developing new protocols and applications in Molecular Imaging to show the greatest interest in uEXPLORER," Jeffrey Bundy, chief executive officer for UIH North America, told HCB News. "Now that we have received FDA clearance, we will be working on market pricing for the uEXPLORER."

Plans for building the solution stretch back to 2005 when Cherry and his colleague, Ramsey D. Badawi, professor and molecular imaging chair in radiology at UC Davis, first thought of the idea.

The two launched the project in 2006, which ran into a big break in 2015 when the National Institutes of Health awarded Cherry and Badawi a five-year grant of $15.5 million for the endeavor. The researchers then conducted an extensive search for a vendor to partner with in building a prototype of the machine, finally selecting UIH America, a North American subsidiary of Shanghai United Imaging Healthcare, which made its U.S. market debut at the 2018 Radiological Society of North America conference.

Upon its completion, the prototype underwent testing, producing its first images in November 2018, an experience that “stunned” Cherry as he gazed at the very first scans made by the machine. He attests, though, that further study will need to be conducted around its applications.

“Our focus is now shifting from the technology to the applications, both in research and clinical use. The EXPLORER scanner opens up many new opportunities, and careful studies will need to be done to quantify the improvements and benefits across these different application areas,” he said. “While I'm sure there will be further technological improvements that will be developed in academia and industry, we believe the greatest impact now will come from using the unique capabilities of the EXPLORER scanner to expand the range of applications of PET.”

Distribution of uEXPLORER is slated to begin at some point in early 2019.