CEA-Scan data

Data from the pivotal Phase III trial IMMU used to gain approval for CEA-Scan were published in the Journal of Clinical Oncology. The trial, in 210 patients with suspected recurrence of colorectal cancer, showed increased detection rates over conventional imaging (primarily computed tomography) in 122 patients with known disease, and improved imaging significantly in 88 patients with hidden cancer.

Sensitivity (true positive) of the scan was 55 percent compared to 32 percent for conventional imaging in the abdominal organs other than liver (p=0.007), and was 69 percent versus 48 percent in the pelvis (p=0.005). Positive predictive value was 98 percent when both CEA-Scan and conventional imaging were used, compared to 68-70 percent for using each alone, which may eliminate the need for histology to confirm imaging results, the report concluded. ...