Trial results of SoftScan's optical breast imaging system promising
SoftScan is designed to detect breast lesions with a high degree of accuracy, using a laser-based optical imaging system, which is believed to be more effective in detecting lesions in women with radiologically dense breast tissue.
"The trial results are very encouraging, because they show that SoftScan is a promising new method for detecting breast cancer. Early detection of breast cancer increases the number of treatment options available to patients, as well as the likelihood that treatment will be successful, which improves the chances for survival," says Dr. Nathalie Duchesne, the chief investigator of the study, and a radiologist at the Clinique radiologique Audet, a leading North American breast cancer center affiliated with St-Sacrement Hospital and based in Quebec City (Canada).
The primary objective of the SoftScan Phase II clinical trial (Pilot study) was to assess the feasibility and safety of SoftScan in detecting breast anomalies. Test volunteers first underwent X-ray mammography, and then were imaged with SoftScan. The optical images were then compared to X-ray mammography and biopsy findings by a trained breast radiologist. A secondary objective of the study was to compare patient comfort with X-ray mammography.
Thirty-one women between the ages of 39 and 65 were enrolled in the trial. The sample included women with a variety of breast characteristics and disease conditions, including cysts, solid benign lesions, and malignant lesions. Results of the trial revealed that SoftScan effectively imaged three of the four malignancies (one was outside of the scan area), three of the six solid benign lesions (two were outside of the scan area), and six of the seven cysts. SoftScan was also able to identify scar tissue.
During the Phase II trial, a 10-point self-report rating scale was used to assess procedure discomfort (1 equals No discomfort, 10 equals Severe discomfort). The average discomfort rating for SoftScan among women in the Phase II trial was 3.2, compared to an average of 7.2 for X-ray mammography, which is a statistically significant result. No adverse events were reported.
Edited by Maeve McKenna
Assistant Editor, Photonics Online