iCAD Launches 10-Year Study to Examine IORT Treatment Outcomes

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Of the 250,000 new cases of breast cancer detected annually, intra-operative radiation therapy (IORT) vendor iCAD believes its Xoft Axxent eBx system may be able to treat as many as 110,000, sparing many women the months-long, post-surgical treatment associated with external beam radiation therapy (EBRT).

The company is launching a 10-year study to get some hard data behind these predictions, says vice-president Peter Espo, but if the research pans out, it could represent a leap forward in the post-surgery quality of life for patients.

“Physicians are really seeking the ability to operate under a standard IORT protocol and study the long-term outcomes of their patients,” he says.

Espo claims that the iCAD non-isotope brachytherapy solution “represents the next step” in physician treatment of breast cancer, which has shifted from radical mastectomy to breast conservation.

By reducing post-lumpectomy radiation fractions to a single dose delivered prior to closing the surgical site, he says, IORT can lower hospital costs and also improve patient outcomes.

“It provides terrific access for patients who might otherwise not be compliant” with EBRT treatment schedules for travel, lifestyle, or employment complications, Espo says.

“That is the underlying rationale for the technology and why we’re seeing growth in that business in terms of adoption.”

Around 70 Xoft Axxent eBx systems have been installed throughout the country, with only 20 to 25 treating with IORT. With 50 participating sites and around 1,000 patients in the study, Espo hopes the company will generate the long-term follow-up data necessary to prove its case.

“For those physicians out there who are interested in using this technology and moving to this single treatment following lumpectomy, the protocol will give them the opportunity to try that procedure with the Xoft system,” says Michael Patz, iCAD Director of Clinical Affairs.

Opportunities are still available for participant sites to enroll in the multi-modality study, Patz says. Investigators will likely identify suspicious lesions or tumors with MRI, then ultrasound to confirm location, and then annual follow-up mammograms. Any actual tumors will be confirmed through biopsy.