Novel stereotactic radiation therapy system receives 510k FDA clearance for treatment of early stage breast cancer

The FDA has granted 510(k) clearance to GammaPod, a first-of-its-kind stereotactic radiotherapy system, for the treatment of early stage breast cancer.

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GammaPod receives 510(k) clearance

The GammaPod is a first-of-its-kind stereotactic radiotherapy system that targets tumors with thousands of beams of radiation delivered with pinpoint focus by 36 rotating sources. Photo courtesy: University of Maryland Medical System/Medical Center.

GammaPod receives 510(k) clearance

The GammaPod is a first-of-its-kind stereotactic radiotherapy system that targets tumors with thousands of beams of radiation delivered with pinpoint focus by 36 rotating sources. Photo courtesy: University of Maryland Medical System/Medical Center.

“We believe this novel radiotherapy system has the potential to change the paradigm for treating early stage tumors, negating the need for surgery for some patients,” said GammaPod co-inventor William F. Regine, MD, FACR, FACRO, the Isadore & Fannie Schneider Foxman Endowed Chair and professor of radiation oncology, University of Maryland School of Medicine (UMSOM), and chief of radiation oncology, University of Maryland Marlene and Stewart Greenebaum Comprehensive Cancer Center, Baltimore, MD.

“With this breast-specific treatment system, we will be able to deliver high-dose radiation to a tumor while minimizing damage to normal breast tissue and, even more importantly, to major organs such as the heart and lungs,” added Dr. Regine.

Current advances in imaging and screening have enabled breast cancers to be diagnosed at earlier stages. These patients—in whom the tumor has metastasized but is confined to the breasts or nearby lymph nodes— typically undergo breast-conserving surgery to remove the tumor, followed by 3 to 6 weeks of radiation treatment.

Until now, stereotactic radiation therapy has been used to treat brain cancers and cancers in the lungs, spine, and liver. For these applications, it is called stereotactic body radiation therapy (SBRT). This technology can deliver high-dose radiation directly to the tumor, resulting in fewer treatments than required with standard radiation therapy, and sparing nearby healthy tissues.

GammaPod—which takes its name from the gamma radiation used and its pod-like shape—was developed to use stereotactic radiation to treat breast cancers. It targets tumors with thousands of beams of radiation delivered with pinpoint focus by 36 rotating sources. Treatment involves patients lying prone on a couch, where they are immobilized by a patented vacuum-assisted cup while the couch moves to allow the radiation to “paint” the tumor. The treatments take 5 to 40 minutes each.

The GammaPod system has been in development for almost 10 years by scientists at UMSOM, who have installed and tested a prototype at the University of Maryland Medical Center.

Data from 15 patients treated with GammaPod were submitted to the FDA. These patients underwent a single “boost” treatment with GammaPod at the site of tumor excision, plus 3 weeks of traditional radiation treatments to the whole breast. Total treatment time was reduced by three to four treatments.

Principal investigator Elizabeth M. Nichols, MD, assistant professor of radiation oncology and clinical director, Department of Radiation Oncology, UMSOM, said that these initial results validated the safety of the GammaPod system.

“The GammaPod delivers a uniform dose to the tumor but the amount of radiation drops off rapidly outside the targeted area with a substantially reduced dose to healthy breast tissue. We believe that this reduced exposure will result in better cosmetic outcomes for patients,” said Dr. Nichols.

In future clinical trials, researchers will study ways to use the GammaPod system both pre- and postoperatively to assess its efficacy in reducing tumor size, or even destroying tumors.

“The GammaPod has the potential to significantly shorten the treatment time to a few sessions or possibly even one treatment,” said co-inventor Cedric X. Yu, DSc, clinical professor of radiation oncology, UMSOM, and chief executive officer of Xcision Medical Systems, LLC, which he founded in 2006. “We envision that one day we’ll be able to neutralize a tumor with a high dose of focused radiation instead of removing it with a scalpel. This approach would spare patients the negative side effects of surgery and prolonged radiation treatments, significantly improving their quality of life.”

Dr. Yu and colleagues expect the GammaPod system to be available for treatment in Spring 2018.

Dr. Yu and Dr. Regine are inventors of GammaPod with patent rights and are also shareholders of Xcision Medical Systems, LLC, which manufactures the device.