At long last, Ontario starts funding PET exams

By Andy Shaw

TORONTO – The Ontario Ministry of Health and Long-Term Care announced in July that after seven years of tests and evaluations, it will begin remunerating physicians for scanning patients using positron emission tomography (PET) equipment.

Even so, the funding will be on a qualified basis – only for certain medical problems where the use of PET has been shown to offer a clinical benefit, according to the Ministry of Health.

Critics say the Ministry has been far too cautious and slow to endorse a technology that provinces like British Columbia and other health jurisdictions long ago welcomed into their clinical fold.

And it took an international embarrassment for Ontario and Canada to prompt the decision. The Ministry’s wait-and-see position that prevented doctors from being paid by the Ontario Hospital Insurance Plan (OHIP) for any use of PET was jolted when the aging, medical isotope-producing nuclear reactor at Chalk River, Ontario sprung a leak and its federal government owners shut it down indefinitely.

Not much later, by chance, the international Society of Nuclear Medicine (SNM) and all its PET and other molecular imaging experts from 72 countries were gathering in Toronto for their 56th annual meeting and scientific conference.

Once in town, SNM leadership was quick to react to the dead reactor. As TV news cameras from every major Canadian network rolled at their mid-June conference-opening press briefing, SNM officials, including one Canadian former president, politely but firmly urged the province and Canadian governments to get off their bureaucratic butts – and do something about molecular imaging in general and the isotope shortage in particular.

And some shortage it already is.

“Canada, specifically Chalk River, supplies nearly one-third of the world’s medical isotopes and 50 percent of those we use in the United States,” said SNM’s out-going president, Robert Atcher, PhD, of New Mexico, at the briefing. “We do about 16 million nuclear or molecular procedures a year down there using medical isotopes – so that means roughly half or eight million of them will have to be done by some other means at least for the foreseeable future.”

An SNM poll of 1,100 of its members revealed by Atcher showed that 90 percent said their practices had already been affected adversely by the shortage – forcing cancellations and postponements of patient examinations.

Atcher also pointed out that the 52-year-old Chalk River reactor was typical of the reactors in five other countries (Australia, Belgium, France, South Africa, and Holland) producing medical isotopes. All are nearing the end of their useful lives, are prone to breakdown, and were never designed in the first place to produce medical isotopes.

They were built to do research with weapons-grade materials. Medical isotopes are for the most a profitable sideline. Australia is building the world’s first reactor dedicated to medical isotope production and which doesn’t need weapons-grade raw materials – but it won’t be operational until 2011.

Consequently, in its June 15 “Leader’s Communiqué” the SNM called on all heads of state and other political leaders to “modernize medical isotope production facilities around the world.”

And perhaps with an eye to Ontario’s stubborn stance on PET, the Communiqué also urged healthcare regulators to “.. ensure a clear pathway, free of unreasonable and cumbersome bureaucratic obstacles, so that new and improved facilities can become operational.”

In response, Ontario first came up with $3 million dollars for research into alternative isotopes that don’t need the horsepower of a Chalk River reactor to produce them.

Also, on the day after the SNM press conference, federal Minister of Health Leona Aglukaq appointed former SNM president Alexander J. (Sandy) McEwan as her special advisor on the medical isotope problem. Dr. McEwan is the director of oncologic imaging at the Cross Cancer Institute in Edmonton, as well as professor and chair of oncology at the University of Alberta Faculty of Medicine.

That appointment didn’t do a lot, however, to soothe the sting felt by many just days before the SNM meeting when Prime Minister Stephen Harper, frustrated with Atomic Energy of Canada’s inability to get its new MAPLE reactors working, announced Canada would soon be out of the medical isotope business altogether.

What SMN officials felt Mr. Harper failed to grasp was the compelling advantage of isotope-tracing molecular imaging procedures.

“They can catch life-threatening diseases at a much earlier stage than other forms of imaging. What a molecular image shows is a change in the metabolism of tissue so it can pinpoint a cancer hot spot, before a tumour even forms,” explained Dr. McEwan.

He further pointed out that other imaging modalities don’t see the cancer until some sort of malignant construct arises. Similarly, in cardiac work, molecular imaging can reveal “flow reserves” in arteries indicating potential trouble long before plaque build-ups and other blockages are visible to other imaging systems.

But so far, Ontario’s 10 PET machines have been used almost exclusively for clinical trials and research, and not often put in the hands of doctors to do potentially life-saving scans of regular patients.

Why in heavens not? – asked one former Ontario doctor, now head of nuclear medicine at BC Children’s Hospital in Vancouver.

“Ontario has taken a side road and gone looking too long for proof of PET’s cost-effectiveness,” said Dr. Helen Nadel, a widely recognized expert in low-dose PET-CT for paediatric examinations. “But in BC we long ago recognized its clinical effectiveness.”

Ontario legislation announced in late July has now put PET under the umbrella of OHIP, giving the OK to scans that “… have been proven to be clinically effective.” They include seven cancer-catching procedures for lung, colorectal, and thyroid cancers as well as lymphoma. Scans to assess “myocardial viability” of transplant patients are also approved.

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Alliance formed to train lab technologists in southern Ontario

By Jerry Zeidenberg

OSHAWA, ONT. – The University of Ontario Institute of Technology has announced a partnership with a large hospital and a private-sector lab to improve the skills of its lab medicine students. The school also hopes to train and graduate larger numbers of skilled technologists, thereby addressing Canada’s looming shortage of lab professionals.

In July, the UOIT signed a letter of intent with Oshawa-based Lakeridge Health and Holburn Biomedical of Bowmanville, Ont., to make use of the facilities of the hospital and the private lab to train lab medicine students in advanced techniques and technologies.

The project will initially focus on immunohistochemistry (IHC), which is used in the diagnosis of cancer and other diseases, and can predict whether a patient will respond to certain therapies – a technique known as pharmacodiagnostics.

In turn, this work could lead to improvements in treatments offered at the R.S. McLaughlin Durham Regional Cancer Centre, within the Central East Local Health Integration Network area, as well as across Canada.

Dr. Ronald Stead, president of Holburn Biomedical, said the partners could in the future train students in other areas, as well – such as microbiology and clinical chemistry. “As this evolves, there may be other technologies that we can set up for the students.”

Dr. Stead noted that lab medicine is quickly progressing, with new techniques and technologies appearing all the time. Not only will the students learn such advanced techniques through time spent in the private lab and the public hospital, but they may also help devise new approaches through research projects.

For its part, the University of Ontario Institute of Technology runs a program that’s unique in the country – it’s said to be only post-secondary institute that offers university degrees in lab medicine. Students can then go on jobs in the lab sector or pursue graduate degrees.

Canada faces a severe shortage of laboratory technicians in the near future – according to some estimates, 50 percent of the country’s 20,000 lab technologists will be eligible for retirement by 2015.

Clinical labs are already hard-pressed for skilled lab professionals, and the situation may become critical in the future unless new programs to train and develop skilled technologists are developed.

Dr. Stead commented that private labs like Holburn Biomedical could step in, creating simulated labs where students can be educated in conjunction with hospitals, universities and community colleges. He has just such a partnership in mind for UOIT and Lakeridge Health: “We could double the number of students in their lab medicine program,” he said. UOIT currently trains 40 students in clinical lab medicine a year.

Careers in lab medicine should be of interest to young people, as they’re virtually guaranteed to find work once they complete a training program. “There’s a real benefit if they choose to go into a lab program,” said Dr. Stead. “There’s a job at the end of it.”

That’s particularly relevant to the Oshawa, Ontario area, where General Motors of Canada is headquartered. The region’s economy has suffered with the recent downturn in the automotive sector. Healthcare, on the other hand, offers growth opportunities in areas like laboratory medicine.

UOIT and its partners are hoping that by developing local expertise in lab sciences, they will also generate spin-off businesses and attract other enterprises to the area. They are aiming for the region to become a source of knowledge workers for hospital and private laboratories across the country.

For its part, Holburn, which is located in the Clarington Science and Technology Park, provides laboratory services in pathology, drug development and target localization, particularly in relationship to gastrointestinal diseases. In business for almost 15 years, it has state-of-the-art facilities that were built three years ago.

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Toronto imaging-software company wins contract in Caribbean, Africa

SIMMS, a Toronto based medical-imaging software company, has been awarded a contract to digitize the facilities and operations of the Heart Institute of the Caribbean. By utilizing the SIMMS Enterprise solution, the Heart Institute of the Caribbean will be able to coordinate the workflow of five facilities that are geographically dispersed across three countries.

Three facilities are located in Jamaica – two are in the capital of Kingston, with another in Mandeville. A fourth site is situated in the Cayman Islands, and a multi-million dollar, state of the art facility, is currently being developed in Port Harcourt, Nigeria. The facility in Nigeria is expected to be the first of many in Africa.

Over one hundred healthcare facilities across North America have implemented the SIMMS Enterprise, an integrated Picture Archive Communication System (PACS), Radiology/Cardiology Information System (RIS), transcription and billing solution. For its part, the Heart Institute of the Caribbean plans to streamline its site workflow, maximize out-patient productivity and improve communications through the web-based solution.

Dr. Ernest Madu founded and runs the Heart Institute of the Caribbean. Dr. Madu, a cardiologist, graduated from the University of Nigeria and obtained further training at the Albert Einstein College of Medicine & Medical College of Ohio, in the United States. He is board certified in internal medicine, cardiovascular medicine, nuclear cardiology and forensic medicine. He has also held faculty positions at the University of California, Los Angeles (UCLA), the University of Tennessee, Vanderbilt, and the University of Florida.

Dr. Madu believes that people in the developing world have a right to world-class healthcare. Since its opening in 2005, the Heart Institute has been dedicated to preventing and treating heart and blood-vessel diseases through appropriate use of leading-edge technology, research and education.

Patients at the Heart Institute of the Caribbean experience the benefits of advanced technology, including telemedicine, while receiving services that focus on their individual needs.

SIMMS has been effective in motivating their clients to adopt the SaaS (Software as a Service) model. There is a growing demand in the market to remove the IT headaches and back end responsibilities from the healthcare facility, and provide services at a much more affordable price. Most healthcare facilities do not have the extra staff or the technology background to effectively run a complicated solution, and the Toronto-based group has designed its software around that premise.

Since more than 20 cardiologists and radiologists will be reporting from parts of the Caribbean, Europe, United States and Canada, HIC needed a solution that would be easy to install on remote workstations and could be accessed simultaneously throughout a variety of time zones.

Recently a patient was given his assessment in Jamaica and travelled to the United States for surgery. The surgeon had already previewed the information and test results and completed his preparation before the patient even landed in the U.S.

Over the next 12 months, HIC will conduct approximately 10,000 diagnostic studies. The Heart Institute conducts studies in several standard radiological modalities, including ultrasound, X-ray, nuclear medicine, (MRI and CT are being implemented in Port Harcourt), in addition to their complete portfolio of cardiac studies.

A new cardiology module and SmartViewer was designed and added to SIMMS Enterprise to satisfy the requirements of the HIC cardiac facilities. The expandable module is designed to distribute, archive, and organize all of the Heart Institute’s cardiac-related modalities, including echocardiograms, stress tests, nuclear scans, and angiograms from all of their facilities and allows for immediate interpretations and dictations. The SmartViewer reduces the amount of clicks required by cardiologists and will decrease the turnaround time to complete accurate patient reporting.

The cardiology module is the second to be introduced into the SIMMS Enterprise this year. In January, digital mammography was added to meet rapidly growing demands.

While the demand for better healthcare in developing nations continues to grow, it is truly exciting to see an African born, American trained, Jamaican cardiologist select a Canadian healthcare technology product to coordinate global expertise and diagnostic assessments.

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Tomosynthesis for breast imaging approved in Canada before the US

By Paul Brent

While digital mammography has presented clinicians with workflow and image clarity advantages over analog film-screen mammography, another great leap forward in finding cancers of the breast has recently appeared in the form of tomosynthesis.

First off the mark in this area is Hologic Inc., which is marketing a clinical application in Canada through Christie Group, of Montreal.

Producing three-dimensional images rather than the 2-D images of conventional analog or digital systems, the first-of-its-kind system creates its unique view of the breast by taking a series of low-dose exposures – about 5-10 percent of a normal mammogram dose – which taken together have a total radiation dose in the range of a single conventional mammogram.

It is not the similar radiation dosage, however, but far better clinical images that have medical professionals excited about Hologic’s system. “Tomosynthesis is the next generational method of doing X-ray imaging of the breast,” said Andy Smith, director of imaging science with Hologic.

The great promise of tomosynthesis is the detection of smaller cancers, which conventional systems just can’t find. Hologic estimates that only about 70 percent of breast cancers are found with conventional screening, and that number is even lower for patients with dense breast tissue.

Hologic’s next-generation system utilizes a selenium detector to capture multiple images at a number of different source angles. The slices can be viewed individually or stacked to create a three-dimensional view. The promise of tomosynthesis is excellent visibility of lesions, which includes the reduction of “structure noise” from dense tissue.

On a related note, there’s a difficulty in distinguishing healthy tissue from cancers with conventional screening, which results in a relatively high rate of patient callbacks for re-examinations, something that Hologic hopes to address with its new system. The Bedford, Mass.-based company estimates that the callback rate in the U.S. for conventional breast exams is 10 percent. Based on nationwide statistics, out of 1,000 average mammograms, just 5 will actually result in cancer detection, but 100 will result in patient callbacks.

“Approximately 995 of the patients that you are looking at don’t have cancer, and yet for 100 there is something going on where the mammogram is not clear enough,” said Smith.

Hologic predicts that its new system, which has been in clinical use in Europe for less than one year, will reduce the callback rate by between 25 percent to 40 percent.

That might not sound like a huge issue until one considers that most women over 40 have an annual mammogram and that an average of one in eight will develop breast cancer in her lifetime.

“When you think of how many times they get a mammogram from age 40 to age 70, the doctor in the screening population has to look at a whole lot of images to find true cancer in just a few,” said Smith.

Hologic and other equipment manufacturers have been racing to develop tomosynthesis for a number of years. The first prototype was developed by a team of researchers at a Boston hospital, which published a paper on the approach. “That was really the inspiration for our company trying to commercialize it,” said Smith.

Advances in computing speed were also essential: the complex mathematics behind processing the images demanded far more powerful computers to handle the profusion of information-rich images. In the end, it was computer systems designed for processing heavy gaming and video uses that would power the Selenia Dimensions unit. “The original images took maybe a day, 24 hours worth of computer time to generate a single image,” said Smith. “We have now got that down to one second.”

Hologic has yet to receive U.S. FDA approval for its tomosynthesis system, which has limited its spread in that country to about 15 locations and research-only use. However, tomosynthesis was approved by Health Canada in March and a facility in Calgary already has the technology in use.

North York General Hospital made headlines in May when it became the first hospital in Ontario to purchase Hologic’s system.

A $2-million donation from Charlotte and Lewis Steinberg, of the famed supermarket family, has funded the purchase of three mammography systems, two with tomosynthesis capability and a third that will be used during biopsies.

The Steinberg’s donation was not just a random act of philanthropy: Charlotte Steinberg was once an X-ray technician at a Montreal hospital where she worked with breast cancer patients.

The Steinberg’s donation is “allowing us to transform our entire mammography department in two hospitals over to digital imaging, including our biopsy capability and tomosynthesis,” said Dr. Liz LaMere, chief radiologist and director of medical imaging at North York General.

While excited about the promise of greater detection capability and reduced callbacks, Dr. LaMere also noted that tomosynthesis should make the procedure easier on the 9,000 patients that her seven-radiologist mammography unit sees each year.

“It can reduce the amount of time required for the patient to have the overall experience of having her mammogram taken, not just the actual moment of time when the image is taken, but also knowing women are left in the room by themselves while the tech goes outside to process the film,” she said. “It also helps keep them more comfortable during that time period, because they have someone with them all the time.”

North York General’s three digital mammography machines, two with tomosynthesis capability, will be operational by fall 2009. The approximately 9,000 patients who are tested annually for breast lesions include those referred by their family physician for routine screening, patients referred through the Ontario Breast Screening Program (OBSP) at the hospital’s Branson site, as well as those referred for a diagnostic assessment, encompassing patients referred to the BMO Financial Group Breast Diagnostic Centre, which opened at the hospital’s General site in 1997.

This centre was one of Canada’s first centres for rapid assessment of breast patients, offering a multidisciplinary approach to diagnosis of breast cancer.

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