Sicel Co-Founder And Medical Director Responds To The Recent New York Times Series Highlighting Potential For Serious Risks Associated With Radiotherapy

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Co-Founder and Medical Director of Sicel Technologies addresses the recent New York Times Series that highlights the potential and serious risks associated with radiation therapy. DVS (The Dose Verification System) is the only FDA cleared implantable dosimeter available to the market that has the ability to read the actual dose delivered to the tumor site during radiation therapy.

The recent series of articles in The New York Times written by Walt Bogdanich et al highlight the catastrophic events related to the misadministration of radiation therapy. These tragedies are the cause of great concern and enormous consternation for both patients and physicians.

From the first reported use of radiation to treat malignant tumors and benign processes, medical personnel involved in the application of radiation have been highly concerned with the treatment’s therapeutic benefit and side effect profile.

Radiation therapy’s long history of improving survival and palliation among patients with malignant disease is due in no small part to the technological advancements designed to minimize the dose delivered to normal tissue while maximizing the therapeutic dose to the malignant tissue (e.g IMRT).

Unfortunately, these same technological advances that offer so much hope and promise also have the potential to create unforeseen errors such as:
1)    The lack of a reliable “check and balance” system that identifies the source of the error in real time and disallows the radiation beam to stay active in the event of an overdose.
2)    Human error, no matter how remotely possible, related to patient set up, treatment planning, and dose-calculation errors.

In the series, Bogdanich presents several reasons for why the tragedies in New York State managed to unfold and cites a host of physicians, physicists and patients who call for better safeguards to mitigate the potential for dose misadministration in radiation therapy. In response, the American Society for Radiation Oncology (ASTRO) recently issued a six point plan addressing quality and safety issues to reduce the potential for medical errors.

While on the surface, there may not appear to be a single fix for the underlying issues, it is crucially important to note that a medical device technology exists today that can assist medical professionals in obtaining “real-time” information about variations between expected and delivered dose.

In a recent study (International Journal of Radiation Oncology, Biology, Physics 2008; 72:597) conducted by Sicel Technologies and partially supported by a National Cancer Institute grant, the safety and functionality of inserting a wireless, minimally invasive implantable dosimeter was performed in 30 breast and 29 prostate cancer patients. The DVS (Dose Verification System) cleared by the U.S. Food and Drug Administration measures the real time actual absorbed radiation dose by the tumor under an actual treatment.

Although the DVS does not identify the specific reason for a dose disparity, the crucial point is that the error could be detected and investigated before being repeated on multiple treatment days. Specifically, the results from the 59 referenced patients revealed that the variation between planned and measured actual dose can occur any time during radiation treatment and can be significantly above or below intended doses. The highest incidence for the discrepancies occurred when the target volume was small in order to increase dose to the tumor. The DVS therefore is an instrument that warns of a dose discrepancy for which immediate investigation is required to determine the cause whether due to patient or organ movement, calculation error or machine malfunction.

According to Dr. Daniel Fried, Radiation Oncologist at Wake Forest University and recent user of DVS “…In the past, we had been focused on the small deviations that can occur between the treatment plan and its implementation. However, the greatest potential benefit [for DVS] could actually be the recognition of a potential catastrophic overdosing before it occurs. DVS allows you to know on day one that there is a problem instead of finding out once it's too late to help the patient. In fact, after reading about the breast cancer patient who received 3 times the prescribed dose due to failure to use a wedge, I think that we should start to offer DVS for breast cancer patients…”

Sicel Technologies’ mission was to develop implantable devices to understand the biological effects of cytotoxic therapy on malignant and normal tissue during treatment. Part of this goal was to monitor daily, the radiation dose being delivered to the patient to ensure appropriate dose delivery of the planned radiation dose to the tumor to improve outcome and ensure that the normal tissue was not overdosed.

In light of the current challenges facing medical professionals as well as those companies who develop and manufacture radiation technology, there is a critical responsibility to ensure these advances maximize patient benefit and safety, while minimizing the potential for debilitating risks.

Sicel Technologies remains committed to this cause and looks forward to working with the profession to make DVS the gold-standard of care for use among patients being treated for breast and prostate cancer.

Respectfully,

Charles Scarantino, MD                    
Co-Founder & Medical Director     

Keith Stoneback
CEO                                                

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