Objective: To evaluate the clinical usefulness of iodine-125 labeled monoclonal antibody (MAb) 3H11 in radioimmunoguided surgery (RIGS) for patients with gastric cancer.
Methods: Thirty-five patients with primary gastric cancer were enrolled. Via endoscopy, iodine-125 labeled MAb 3H11 was injected into submucosa around the tumor. All patients underwent surgery 4 to 11 days after administration. Intraoperative radioimmunodetection was performed using a hand-held gamma-detecting probe. The counts of target sites were obtained, and tumor-to-normal tissue (T/NT) ratios were calculated. The T/NT ratio of 3.5:1 was taken as the lowest threshold value of positive gastric wall infiltration, and 3.0:1 for lymph node metastasis. Serial sections of those RIGS-positive lymph nodes, which were originally diagnosed as negative by routine histology, were made. Immunohistochemical staining was performed to detect the existence of lymphatic micrometastasis.
Results: Of thirty-five patients, 33 underwent RIGS successfully. The accuracy rate in detecting tumor infiltration of the incision margins was 97.0%, and the specificity 98.5%. In the group of patients with an interval of 6 to 8 days between injection and operation (n = 25), the RIGS results were satisfying. For the detection of lymphatic metastasis, the sensitivity of RIGS was 83.6%, the specificity 95.0%, and the accuracy 91.3%. The existence of lymphatic micrometastasis were verified immunohistochemically in 52.6% (10/19) of those RIGS positive but histologically negative lymph nodes.
Conclusion: This study validates the use of iodine-125 labeled monoclonal antibody 3H11 for the intraoperative detection of carcinomatous lesions in gastric cancer.