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

UNLABELLED Monoclonal antibody (moAb) ior egf/r3 is an IgG2a that recognizes the epidermal growth factor receptor (EGF-R). The aim of this study was to evaluate the diagnostic efficacy of the 99mTc-labeled moAb ior egf/r3 for the detection 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 administered 3 mg/50 mCi (1.85 GBq) 99mTc-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 circular orbit with 64 images. The backprojection method was used for image reconstruction with a Hamming-Hann filter. RESULTS Labeling efficiency was always greater than 98.5% +/- 2.1 %. No adverse reactions or side effects were 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%). Overall sensitivity, specificity, accuracy, and positive and negative predictive values 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 metastases not identified previously by other diagnostic methods were detected in the 50% of the patients. CONCLUSION Immunoscintigraphy with 99mTc-labeled moAb ior egf/r3 could be a useful procedure for the diagnosis and follow-up of the patients with tumors of epithelial origin.

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