Fluorescence system correctly identifies residual cancer cells across breast cancer subtypes
Lumicell (Wellesley, MA) has presented new clinical data from its ongoing Phase 2 breast cancer trial with the LUM System, which integrates the LUM015 immuno- and cancer-targeted optical contrast agent, LUM 2.6 handheld imaging device, and decision software to detect cancer cells in real time during surgery.
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The Phase 2 data demonstrated that the integrated LUM System provided complete and instantaneous detection of residual cancer in tumor cavity and the ability to detect all breast cancer sub-types, including invasive ductal cancer (IDC), invasive lobular cancer (ILC), and ductal carcinoma in situ (DCIS) during lumpectomy surgery. The system also correctly identified residual cancer (positive margins) within the tumor cavity in all patients studied, as confirmed by standard histopathology.
In a poster presentation titled "Real-time, intraoperative detection of residual breast cancer in lumpectomy cavity margins using the LUM Imaging System: Results of a feasibility study," Lumicell collaborators at Massachusetts General Hospital's Breast Program presented data from the Phase 2 clinical study in which tumor cavity walls of patients (N = 45) undergoing breast cancer lumpectomy were assessed intraoperatively using the LUM System. LUM015, a cathepsin-activatable fluorescent agent, was administered intravenously approximately four hours prior to surgery. Areas of fluorescence generated at potential sites of residual tumor in lumpectomy cavities were evaluated with a sterile handheld device, displayed on a monitor, excised and correlated with histopathology. The data showed:
- The LUM System showed 100% sensitivity and 73% specificity for detection of tumor ≤2 mm from the margin;
- Invasive ductal, invasive lobular, and areas of ductal carcinoma in situ as small as 1 mm in size were identified using the LUM System; and
- There were no serious adverse events reported during the study.
The Phase 2 data were presented at the 2017 San Antonio Breast Cancer Symposium (SABCS), held December 5-9, 2017 in San Antonio, TX.
For more information, please visit www.lumicell.com.