Phase I of the CIMIT/Ascension NCI study focused on the integration of Ascension's 3D Guidance navigation sensors into an experimental imaging device. Results were sufficiently positive to justify an initial series of image-guided laparoscopic animal studies.
Phase II has focused on clinical studies in humans. Image-guided laparoscopic and endoscopic diagnostic procedures have been evaluated on patients at two partner hospitals - Brigham and Women's in Boston, Massachusetts, and Queen Elizabeth Hospital in Halifax, Nova Scotia. Phase II results to date have confirmed that using real-time image guided laparoscopy and endoscopy to help diagnose pancreatic cancer is "an idea that clearly works", stated Kirby Vosburgh, Ph.D., Principal Investigator of the study and Associate Director of CIMIT.
According to Dr. Vosburgh, pancreatic cancer is challenging to diagnose. First, the pancreas is deep in the body and not normally observed. Second, there are no biological markers that might indicate a person's propensity to develop pancreatic cancer. Perhaps most importantly, the pancreas is not an encapsulated organ - unlike the kidney for example - having a containing membrane. When a tumour grows inside the pancreas, it isn't trapped, causing pressure and pain, but rather spreads to adjacent organs and blood vessels. When finally symptomatic, it is generally too late to remove it safely.
The long-term objective of the CIMIT/Ascension NCI study is to enhance the effectiveness and reduce the morbidity of invasive procedures in the abdomen through the real-time application of improved imaged-based information. During Phase II, with Ascension sensors placed on surgical instrument tips - enabling the fusion of real-time ultrasound with CT images/constructed anatomical models, surgeons have been able to locate targets with "ease, simplicity and greater accuracy", stated Dr. Vosburgh. To date, six - of 25 approved - patients with suspected pancreatic cancer have been examined successfully using "image-registered gastroscopic ultrasound".
Phase II research also confirms the potential for the technology to be successfully applied to other kinds of solid organ cancers and more general abdominal surgeries. The major advantage of minimally invasive image-guided laparoscopy and endoscopy is that they offer patients advanced medical care along with the ability to be ambulatory soon after surgery.
The Center for Integration of Medicine and Innovative Technology (CIMIT) based in Cambridge, Massachusetts, is a non-profit consortium of teaching hospitals and engineering schools that provides innovators with resources to explore, develop, and implement novel technological solutions urgent health care problems.
Ascension Technology's 3D Guidance System for image-guided navigation has been awarded the 2010 R&D 100 Award for its contributions to medical research. Each year since 1962, R&D Magazine has named "the 100 most technologically significant products to reach the marketplace in the past year".
Ascension is in illustrious company this year with IBM, Intel, Siemens, MIT, and NASA among the recipients. Jack Scully, Ascension's Vice-President, stated: "This R&D 100 award is a important honour for Ascension. We are proud our breakthrough work in medicine is being recognized alongside major leaders in the field."
Ascension's 3D Guidance System for image-guided navigation will play a fundamental role in improving the delivery of medical therapies while helping control spiraling costs. 3D Guidance's miniaturized sensors fit into the tip of medical instruments for non-radiating navigation to internal targets - tumours, lesions, anomalies - for diagnostic and therapeutic purposes.
The company's recent inventions of the world's smallest six degrees-of-freedom sensors - 0,9 mm and 0,56 mm in diameter - were key factors in the award. The sensors establish trajectory and navigate ultrathin biopsy needles - as small as 21 gauge, ablation probes, guide wires, and catheters through tissue to the centre of anatomical targets.
The R&D 100 Awards are considered a "benchmark of excellence" for diverse industries, including telecommunications, high-energy physics, software, manufacturing, and biotechnology. Rita Peters, editorial director of R&D Magazine, stated: "The R&D 100 Awards represent some of the most innovative concepts to reach the marketplace in the past year. 2010 is no exception, and we had a particularly strong field of entries for the judges to evaluate."
Winners will be recognized at the R&D 100 Awards Banquet on November 11, 2010, in Orlando, Florida. Ascension's Westley Ashe, Senior Design Engineer will represent Ascension at the award ceremonies.
Ascension Technology Corporation, based in Burlington, Vermont, makes magnetic and optical navigation sensors for medical applications. Its sensors represent the key enabling technology for image-guided procedures. For more information about the company, you can visit the Ascension Technology website. More company news can be found in the VMW December 2009 article Ascension Technology's miniaturized magnetic sensors enable improved procedures.