Where does an 80-ton cyclotron sleep? Not many places, and rarelyin locations convenient for hospitals trying to install positronemission tomography facilities. The difficulty and expense of siting the cyclotrons that producePET radiotracers have been
Where does an 80-ton cyclotron sleep? Not many places, and rarelyin locations convenient for hospitals trying to install positronemission tomography facilities.
The difficulty and expense of siting the cyclotrons that producePET radiotracers have been major impediments to the growth ofclinical PET, according to Wayne Webster, president and CEO ofPracSys. PracSys is a Woburn, MA, start-up firm that promotesan alternative that could help remedy the PET cyclotron dilemma.The company made its debut at this month's Society of NuclearMedicine meeting in Toronto.
If the PracSys solution works, it could conquer many of theeconomic objections that have hindered widespread acceptance ofPET. The bottom line according to PracSys is an entire PET system--fromaccelerator to scanner--for $3 million. The cost of installinga PET facility is currently in the $6 million range.
The PracSys solution is based on using a linear acceleratorin place of a cyclotron to produce radioisotopes. The idea isnot new, but PracSys claims to use a novel design that resultsin a smaller and more reliable accelerator.
"The cyclotron usually forced the (PET) facility out ofthe hospital. This resulted in a lot of construction and expense.The doctor was forced to become a contractor, an architect, aproject manager, and a pharmacist," Webster said. "(Toutilize PET clinically), you have to physically downsize the instrumentsso they fit wherever (the imaging department) is."
A problem with standard linear accelerators is a phenomenoncalled a cascading fault, which occurs when a short in one ofthe accelerator's voltage compartments moves through subsequentcompartments. The short builds voltage as it travels down theaccelerator tube, eventually blowing the unit's capacitors anddisabling the accelerator.
PracSys solved the cascading fault problem by licensing a newtype of accelerator developed by North Star Research of Albuquerque,NM. The design, called a nested high-voltage generator (NHVG)accelerator, insulates each voltage compartment, thus preventingcascading faults, Webster said. If a voltage compartment developsa short, that compartment shuts down, but others can continueoperating and producing radioisotopes.
The North Star design, which uses dual-particle, negative-iontechnology, also reduces accelerator size and weight by substitutinga plastic and transformer oil mix in place of the costly sulfurhexafluoride gas used in other accelerators. The new design eliminatesthe need for a bulky cylinder around the accelerator to containthe gas, according to Webster.
A fully shielded PracSys NHVG accelerator weighs about fivetons, is about 14 feet long and 6 feet in diameter. It can besited in any standard room on any floor of a hospital, Webstersaid. The accelerator can produce enough fluorine, carbon, nitrogenand oxygen isotopes to support two or three PET cameras.
The accelerator is just one part of a PracSys PET system, however.The company has adopted a turnkey approach to PET capital equipmentsales, acting as a systems integrator to supply a customer withall the components needed to start up a PET facility and run itwith fewer staff than existing centers.
"If you're going to sell large-ticket capital equipment,you have to do a few things," Webster said. "You haveto have something unique, and we have this nested high-voltagegenerator. The other part is that you have to become a systemsintegrator, putting all the pieces together that (customers) need."
One of those pieces is the scanner, and PracSys has enteredinto an OEM agreement with UGM Medical Systems of Philadelphiafor its Penn-PET camera. The agreement is nonexclusive, however,and PracSys customers can use any scanner with the PracSys system.
PracSys will also supply the tracer synthesis units neededfor radioisotope production. In addition, the PracSys system includessoftware that not only runs the accelerator but also performspatient scheduling.
Webster founded PracSys in 1991. He was senior vice presidentat PET vendor Scanditronix when that company was sold to GE in1989, giving the multimodality giant its entree into the PET market(SCAN 12/13/89).
PracSys has built four of the NHVG accelerators for industrialuse and is building its first accelerator for PET use. The companyis developing a beta site program and plans to have its firstclinical PET facility installed at Massachusetts General Hospitalby the end of this year.
PracSys claims that by cutting the capital acquisition costof PET in half and reducing the size of the staff required torun a PET facility, users can achieve the Holy Grail of medicalimaging in the 1990s: cost-effectiveness. PET can be a money-saverwhen it reduces or eliminates the need for more expensive, moreinvasive tests, the logic goes.
PracSys can supply potential buyers with customized pro formastatements illustrating PET's money-saving potential. Customersusing a PracSys system who image three patients a day incur anaverage cost of $400 per scan. If the center charges $1800 perscan--about industry average according to a 1991 Coopers and Lybrandstudy (SCAN 3/27/91)--the facility can break even after nine monthsand be profitable after the first year of operation, accordingto Webster.
Whether PracSys can refute conventional wisdom by making PETa cost-saver depends on its financial numbers and technology standingup to the harsh light of health-care practice in the 1990s, accordingto Philip G. Drew of Concord Consulting Group of Concord, MA.
"PET centers do not operate at a profit, and to pretendthat they do is misleading," Drew said. "The numberof people being referred for PET exams with insurers who willpay isn't very large. The $1800 charge for patients is problematic.You can't collect money of that magnitude very reliably."
Webster, however, is optimistic that the company's accelerator-basedsolution is the adaptation PET must undergo to avoid becomingthe dinosaur of medical imaging.
"If there is tremendous cost pressure, which there maybe in the future with managed care, you could bring (patient charges)down to about $850, which is in the range of SPECT, and stillbe profitable," Webster said. "You can't do that ifyou're running a cyclotron operation."
The plaintiff in this case was a technician whose injury wasallegedly caused by lengthy exposure to the MRI system, accordingto William F. Knowles, associate attorney with Elscint's law firm,Seattle-based Gaitoean & Cusack.
"She (the plaintiff) was unable to produce evidence thatwould show the product caused the injury," Knowles told SCAN."That has been the central attack on all EMF cases. Thereis no scientific proof linking the alleged emitter of the electromagneticfield and the injury."
Most scientific evidence relating to damage caused by MRI scanningconcerns changes that are obvious to the senses, such as heatingof tissue, he said. In this case, the allegation was damage causedby prolonged exposure over several years.
OctreoScan is a modified version of Octreotide, a drug soldby Sandoz that is a derivative of the naturally occurring peptidesomatostatin. Mallinckrodt signed exclusive agreements regardingthe technology two years ago with University Hospital Dijkzigtof Rotterdam (SCAN 4/24/91).
Human clinical trials for OctreoScan have been undertaken inEurope and approval is being sought in that market. Mallinckrodtalso plans to apply for approval in Canada and Japan.
ADAC was one of the first licensees signed by BTG's U.S. officein Gulph Mills, PA, after its establishment two and a half yearsago (SCAN 10/4/90). During the prior year, ADAC had acquired technologyand marketing rights for its Genesys gamma camera from Ohio Imaging,which had helped develop the system (SCAN 6/07/89). Shortly thereafter,Ohio Imaging was purchased by Picker International. Both OhioImaging and Trionix Research Laboratory were formed by formerTechnicare executives with rights to further develop and commercializethat vendor's nuclear imaging technology.
The licensing agreements signed with ADAC in May representa portion of the J&J portfolio for which BTG has been grantedexclusive rights, according to the technology transfer firm. Akey technology licensed by ADAC provides for increased resolutionof a gamma camera by utilizing non-circular rotation about thepatient. Other patents are in areas such as variable persistencedisplay technology and gamma camera head design. As part of theagreement, ADAC will transfer technology to BTG USA in digitalimage acquisition and processing.