Detecting and effectively treating cancer as early as possible is the key to patient survival. In addition to chemotherapy, radiation therapy, and other treatments, the disease often requires surgical intervention to remove cancerous cells.
But despite extensive pre-operative planning, surgeons aren’t always able to locate and remove all cancerous tissue during the operation. If the initial surgery leaves cancerous cells in the body, the disease can recur. That, in turn, can lead to another round of invasive surgery. In fact, many cancer patients require additional rounds of surgery to remove cancer cells missed during the first operation. Improving these odds and increasing the chances of successful surgery is critical to effective treatment.
To help cancer patients and their surgeons beat the odds, medical device company Lightpoint Medical Ltd. has teamed up with product development firm Sagentia to develop the LightPath™ Imaging System, the world's first intra-operative molecular imaging system. The LightPath Imaging System is designed for surgeons to use in the operating room during live surgery to determine whether they have removed all cancerous tissue, thereby increasing the chance of success.
Lighting the Way
The LightPath Imaging System is a medical device developed to help guide clinicians during cancer surgery. The system works by detecting Cerenkov Luminescence, the extremely faint light generated by positron emission tomography (PET) imaging agents, including those used to identify cancer.
Currently, confirmation that no further surgery is required can happen only after histological assessment of the surgically removed tissue, a step that can take several days, or even weeks. LightPath is able to assist clinicians immediately, in the operating room, to assess the excised specimen and ensure that a sufficient amount of tissue has been removed. Surgeons can perform this rapid intra-operative tumor margin assessment with high resolution and potentially high diagnostic performance. The system is compatible with commercially available PET imaging agents, so there has been no additional new-agent approval process and, other than administering the imaging agent before surgery, the samples require no further preparation.
Lightpoint Medical approached Sagentia's R&D team with the product concept. The Sagentia team helped to qualify the device's potential effectiveness and the practicality of bringing it to market. During the R&D process, Sagentia worked to help mitigate both technical and usability risks to bring to market a truly innovative medical device.
“Surgeons can use the system during surgery. They inject the patient with a radioactive imaging agent, which is taken up by the cancer cells. The system then provides a method of indicating where the cancer cells are during surgery,” says Nick Collier, Sagentia's CTO. “LightPath allows the surgeons to know where the cancer is and, most importantly, whether they have achieved a clear surgical margin.”
One primary challenge for the project was in developing optical sensors sensitive enough to detect such faint light—especially in a brightly lit operating theater. “We had to understand the physics,” Collier says. “From there, we sought cameras and optics designed to detect light from radioactive sources.”
To describe how faint that radioactive glow can be and how difficult it can be to detect, Collier compares it to seeing a one-milliwatt LED from 10 miles away. “That gives you an idea of what we’re trying to detect,” he says. “We’re basically doing photon-counting.”
Portable Imaging Technology
PET cameras, when used with the appropriate imaging agents, can also be used to determine the presence and location of diseased cells in the body, but the technique requires large, expensive machines, much like MRI scanners, which cannot be used during surgical procedures. The concept behind the LightPath Imaging System was to isolate the same diseased cells using the same imaging agents in a more mobile way at lower cost.
LightPath’s development marks the first time that this technology has been approved and built into a medical device for intra-operative molecular imaging. While developers anticipate that the technology initially will be used in breast-cancer surgeries, it has the potential to help with other types of the disease, such as colon cancer, as well.
Behind the R&D Process
Lightpoint came to Sagentia with the concept, seeking help in determining whether and how it could be developed into a product. The Sagentia team included professionals across a spectrum of disciplines: physicists, electrical and mechanical engineers, bioengineers, and software developers.
“Medical devices are a big part of what Sagentia makes," Collier says. "These are devices that can be used by physicians either diagnosing you or treating you, things like inhalers for asthma that check whether the drug is delivered and check that it’s used the right way.”
The R&D process Sagentia and Lightpoint Medical undertook to develop the LightPath Imaging System included the following steps:
- Conducting a proof of principle study (to determine whether the concept could be translated into an actual product) and conducting extensive laboratory-based testing
- Developing a model (prototype)
- Conducting additional testing in increasingly realistic environments
- Developing pre-production prototypes
- Supporting pre-clinical and clinical trials
“The big questions were: How do we turn this into product? How much light would be emitted? How deep in the tissue would we have to go? There’s a whole range of concepts as to how to detect such low levels of light,” Collier says. “We were trying to reduce risk early. That was a challenge with this product.”
Some critical aspects of Sagentia's R&D process include identifying and reducing technological, operational, and potential manufacturing risks early in the process; determining where major hurdles may arise; and developing and executing a plan for surmounting those hurdles. These factors are especially important when working on a first-to-market, groundbreaking technology such as the LightPath Imaging System.
Taking an Innovative Device to Market
The LightPath Imaging System has received a CE Mark and is now commercially available in Europe. FDA approval for distribution in the United States is pending, with the system expected to become available in North America sometime this year.
As the LightPath story illustrates, Sagentia's R&D process both identifies the viability of medical device technologies and helps in bringing such devices to market. In so doing, Sagentia experts take careful and measured steps to mitigate not only technical risks, but also potential usability risks and even production risks.
Sagentia partners with startups, such as Lightpoint Medical, Senseonics, and T2 Biosystems, as well as with established companies, such as Johnson & Johnson, Smith & Nephew, and Instrumentation Laboratory. Ultimately, Sagentia helps its partner companies bring potentially life-saving medical devices to market, and to the medical community, as efficiently as possible.
For more information on Sagentia, visit http://www.sagentia.com/market/medical-device-development/.
For more information on Lightpoint Medical, visit www.lightpointmedical.com.