The GammaPod  – first stereotactic radiotherapy system to treat early-stage breast cancer – has received 510(k) clearance from the U.S. Food and Drug Administration (FDA), paving the way for the manufacturer to bring the system to market for the treatment of breast cancer patients.

"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.

"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," Dr. Regine added.

With advances in imaging and better screening, most breast cancers are diagnosed at an early stage, when the tumor is confined to the breast or nearby lymph nodes but has not spread to distant parts of the body. Patients typically have breast-conserving surgery to remove the tumor, followed by three to six weeks of radiation.

"The GammaPod has the potential to significantly shorten the treatment time to a few sessions or possibly even one treatment," said inventor Cedric X. Yu, a clinical professor of radiation oncology at University of Maryland School of Medicine (UMSOM).

"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."

Armed with data from a feasibility and safety study, Xcision Medical Systems, a Columbia, Md.-based company that manufactures the GammaPod, sought permission from the FDA this fall to begin marketing the system to hospitals and other medical facilities. The FDA granted the company 510(k) clearance.

Stereotactic radiation therapy is most commonly used to treat brain, lung, spine and liver cancers. It delivers a high-dose of radiation directly to the tumor, sparing nearby healthy tissue, in far fewer treatments than standard radiation therapy. The GammaPod enables this technology to be used for breast cancer.

The researchers submitted data from 15 patients treated with the GammaPod in a feasibility and safety study. Patients received a single "boost" treatment with GammaPod and three weeks of traditional radiation treatments. The results indicate that the GammaPod system can deliver radiation to the breast safely.

"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, a radiation oncologist at Maryland Proton Treatment Center.

In future, the researchers intended to investigate various ways to use the GammaPod before and after surgery, gauging its effectiveness in reducing the size of a tumor to be removed or giving a sufficient dose to destroy it. They would also seek to identify subgroups of patients who may not require surgery after treatment.