CHICAGO – At the Radiological Society of North America (Oak Brook, Illinois) the Cleveland Clinic and Riverain Medical (Dayton, Ohio) jointly reported the establishment of the first study in a program to determine whether chest X-ray computer-aided detection (CAD) can improve on early detection of lung cancer, one of the most insidious forms of cancer.

The program is designed to determine whether chest X-ray CAD, using Riverain’s OnGuard system can help identify hard to detect lung cancer at an early stage when most treatable, thus improving patient survival.

Micheal Phillips, MD, section head of imaging sciences in Cleveland Clinic’s Department of Diagnostic Radiology, at a press conference, said “As it stands now, treatment options are limited because identifying malignant lung tumors in their early stage is so difficult.”

Philips noted that lung cancer kills about 160,000 Americans each year – “more people than prostate cancer, breast cancer and colon cancer combined.”

Currently, only about 16% of lung cancer cases are detected while the disease is still in a localized stage. The five-year survival rate increases from 16% to 49% when the disease is detected early.

The evaluation of X-Ray CAD, via the Early Lung Disease Detection Alliance (ELDDA) program is being funded by a grant from the state of Ohio. Moulay Meziane, MD is the principal investigator for the five-year study that will involve 9,000 test subjects. The participants for the clinical trial will be enrolled in early 2008.

CAD “will allow us to decrease the number of people who develop symptomatic lung cancer,”Philips told Medical Device Daily.

ELDDA is a multidisciplinary program described as having the task of developing, conducting clinical trials and then marketing new image-analysis systems that permit the early detection of lung diseases. This CAD system will be applied to the most widely available and used imaging exam, the chest X-ray to advance early detection and accelerate the commercialization of CAD-detection, image interpretation and multidisciplinary applications of computer science and medical diagnostics.

“Philips called early detection the “key to survivability — if you have early detection there’s a broader range of treatment options ... .”

Philips said the clinic chose to evaluate chest Xrays in conjunction with CAD to determine if it can indeed improve the diagnostic ability of the modality. He noted that early studies have shown that using the OnGuard improves the ability to look “at small nodules on chest Xrays.”

With chest X-ray CAD, he said the software “looks at” the X-ray, identifies regions of interest (actionable/suspicious pulmonary nodules), and circles them for analysis. The radiologist then reviews these areas more closely and determines whether additional follow-up, such as a CT scan, is needed for further evaluation.

He emphasized that chest X-ray CAD does not expose the patient to any additional radiation exposure or require any additional action by – or involvement of – the patient. It is applied by the radiologist after the chest X-ray is taken.

Aside from the large 9,000 patient trial, Philips said that the clinic is doing a 100-patient trial of people with diagnosed lung cancer and compare them to 100 people that have no cancer to determine how well CAD will perform in each of these groups.

The study, which is slated for completion by the end of the year, is a multiple-reader multiple-cases study involving six expert chest radiologists, six general radiologists, and six pulmonologists.

Sam Finkelstein, president of Riverain, said at the press conference he believes these trials will put the OnGuard to the test “and confirm what we believe is the opportunity, and that’s to find lung cancer early enough to make a difference in survivability.”

In other news from the RSNA showroom floor:

• Orthocrat (Tel Aviv, Israel) used the meeting to showcase the latest updates to its TraumaCad software, its 2.0 edition. The company said that TraumaCad 2.0 provides additional resources that facilitate more thorough and accurate planning of foot, spine, hip, pediatric and trauma surgeries. The new version also offers more reporting options, including patient positioning, it said. The new software also provides specialized templates that simplify planning for the most common types of orthopedic surgery.

Adam Ehrenraich, MD, an orthopedic surgeon and the TraumaCad product manager, told MDD that his company provides software “that enables the orthopedic surgeon to use a PACS, to work in a digital filmless environment and it’s a comprehensive solution that can answer to any subspecialty in orthopedic surgery and that’s part of the new thing that we include on the [new software].”

A compelling part of the company’s story, which began a mere three years ago, is the fact that it was founded and is run by orthopedic surgeons, so they know what features they want to incorporate into new versions of their software.

“I think it shows on the software,” said Ehrenraich. “We think about the workflow” for individual doctors and their unique needs. Because of the software’s flexibility, the company’s products are equally suited for small- to medium-sized practices as well as for large academic institutions.

The company said TraumaCad 2.0 provides specialized templates that simplify planning for the most common types of orthopedic surgery. Upgrades include updated measurement wizards, an advanced user interface, a redesigned template library and semi-automated templating tools.

Ehrenraich said that the new software displays images from a full range of modalities, allowing surgeons to archive preoperative plans with patient files and view them in the operating room.

Perhaps most important to physician uptake of a new product is its ease-of-use, and Ehrenraich noted that the software is “very intuitive.” He also noted that the company is able to make updates to the software and its capabilities very quickly from a remote location. “Every week we update the templates for every customer.”

• Ziehm Imaging (Nuremberg, Germany), a provider of mobile imaging solutions for healthcare, presented two fully digital (FD) radiology products at the meeting: Ziehm Vision FD and Ziehm Vision R FD.

The company said they are the first of their kind in the industry, and offer superb image quality with Object Detected Dose Control, delivering the lowest possible dose. Each design also offers lightweight maneuverability which makes them suitable for any imaging procedure. The company said the Ziehm Vision FD incorporates the latest advances in technology and design, offering fully-digital and distortion-free images and readily mobile units.

With the introduction of digital flat-panel detectors (FPD) in mobile fluoroscopy, Ziehm Imaging’s products offer better patient access and mobility together with an unmatched dynamic range for perfect soft tissue and skeleton imaging at the same time, it said.

“It’s got more dynamic range [and] more uniform imaging which really leads to better navigation procedures and navigation connections and more uniform reference points,” Delton Hyatt, CEO of the company’s U.S. headquarters in Riverside, California told MDD.

Hyatt also stressed the company’s dedication to increasing surgeon uptake of its products, noting the announcement last Monday of the launch of the Ziehm Academy, its training center for various clinical applications.

He said the first training course has already taken place last month at the Steadman Hawkins Clinic of the Carolinas (Spartanburg, South Carolina). Altogether, 55 participants were representing 19 medical facilities. Attendees at the session were trained on intra-operative vascular imaging procedures being performed today with mobile c-arms. The U.S. branch of the academy also launched the Ziehm Mobile Learning Lab, which is designed to allow for the Ziehm Academy to partner with the medical community to provide in-depth and focused application trainings for medical staff.

No Comments