The Imagio opto-acoustic imaging (OA/US) system does a good job of distinguishing benign from malignant breast tumors, according to a Phase 3 clinical trial.
Seno Medical Instruments said its system, which combines laser optics and ultrasound, works by differentiating between the masses of benign and malignant tumors.
The company presented the results of the Phase 3 PIONEER clinical trial on Imagio’s effectiveness at the American Roentgen Ray Society annual meeting in New Orleans, May 1-5.
“These data reinforce previous findings suggesting that opto-acoustic diagnostic imaging may improve our ability to differentiate between benign and malignant breast masses,” Dr. Reni Butler, principal investigator in the trial, said in a news release. “This could help us decrease the number of unnecessary breast biopsies performed for benign findings, reducing patient anxiety, discomfort and health care cost.”
Seno’s scientists designed Imagio to identify two cancer hallmarks: the presence of abnormal blood vessels in tumors and the reduction in oxygen levels in tumor blood cells. Neither of these conditions occurs in benign tumors.
The company has filed a Premarket Approval (PMA) request for Imagio with the U.S. Food and Drug Administration.
“Unlike previously investigated functional modalities, opto-acoustic imaging provides real-time anatomic and functional information without ionizing radiation or the need for intravenous contrast injection, making it a potentially safer and more convenient option for patients,” Butler said.
The PIONEER trial (NCT01943916) enrolled 92 patients whose solid breast tumors had been previously assessed with conventional diagnostic ultrasound. Researchers wanted to see how well Imagio could differentiate benign and malignant tumors.
They looked at five features. The three internal features were levels of hemoglobin, a protein in red blood cells; the presence of internal blood vessels; and blush, or tumor enhancement in imaging exams. The two external features were boundary zone vessels — that is, blood vessels in areas on tumor boundaries — and peripheral zone vessels, or vessels outside the boundaries.
The team then correlated the findings on the five features with known characteristics of benign or malignant tumors.
Malignant tumors had significantly higher opto-acoustic scores than benign tumors, researchers found.
Another finding was that external features were better predictors of malignancy than internal features — because there were greater differences in external-feature scores between benign and malignant tumors than internal-feature scores.
“We are encouraged by these promising study results, further underscoring the clinical utility of the Imagio OA/US breast imaging system as an effective tool to aid in the assessment of breast masses,” said Tom Umbel, Seno’s CEO. “We are confident that OA/US imaging has the potential to address significant unmet needs in the characterization and diagnosis of breast lesions and look forward to announcing the results of PIONEER, our pivotal U.S. study of more than 2,000 patients, later this year.”