Tc-99m-labeled antihuman epidermal growth factor receptor antibody in patients with tumors of epithelial origin: Part III. Clinical trials safety anddiagnostic efficacy

Monoclonal antibody (moAb) ior egf/r3 is an IgG,, that recognizes the epide rmal growth factor receptor (EGFR). The aim of this study was to evaluate t he diagnostic efficacy of the Tc-99m-labeled moAb ior egf/r3 for the detect ion of epithelial-derived tumors, their metastases and recurrences. Methods : One hundred forty-eight adult patients (51 women, 97 men; mean age 53 +/- 13 y) who were suspected of having cancer of epithelial origin were admini stered 3 mg/50 mCi (1.85 GBq) Tc-99m-labeled moAb ior egf/r3 by intravenous bolus injection. Planar anterior and posterior images of the lesion sites and suspected metastases were acquired at 2, 4, 6 and 24 h after injection, and SPECT images were scanned at 5 h postinjection, using a 360 degrees ci rcular orbit with 64 images. The backprojection method was used for image r econstruction with a Hamming-Hann filter. Results: Labeling efficiency was always greater than 98.5% +/- 2.1%. No adverse reactions or side effects we re observed. Results of the biopsy specimens showed that 85.1% (126/148) of the patients had tumors of epithelial origin, 14.2% (21/148) were negative and 0.7% (1/148) had non-Hodgkin's lymphoma. The sensitivity rate by organ was as follows: brain (8/8, 100%), digestive tract(10/11, 90.9%), head and neck (17/23, 73.9%), lung (52/62, 83.9%) and breast (16/18, 88.9%). Overal l sensitivity specificity accuracy, and positive and negative predictive va lues of the immunoscintigraphic imaging were 84.2% (106/126), 100.0% (22/22 ) 86.5% (128/148), 100% (106/106) and 52.4% (22/42), respectively. New meta stases not identified previously by other diagnostic methods were detected in the 50% of the patients; Conclusion: Immunoscintigraphy with Tc-99m-labe led moAb ior egf/r3 could be a useful procedure for the diagnosis and follo w-up of the patients with tumors of epithelial origin.