DETECTION OF HEPATOCELLULAR-CARCINOMA WITH A NEW ALPHA-FETOPROTEIN ANTIBODY IMAGING KIT

Purpose: The aim of this phase II study was to assess the clinical uti lity and safety of AFP-Scan (Immunomedics, Inc, Morris Plains, NJ), a technetium-99m (Tc-99m)-labeled anti-alpha-fetoprotein (AFP) Fab' imag ing kit, in the evaluation of hepatocellular carcinoma (HCC), in compa rison to computed tomography (CT), Patients and Methods: Twenty-five c onsecutive patients with a history of HCC were examined by planar and single-photon emission computed tomography (SPECT) imaging at 6 and 24 hours after intravenous (IV) injection of 1 mg AFP-Scan labeled with 925 MBq Tc-99m, Results: In 20 patients, there was a specific binding of the Fab' antibody to the tumor, whereas in four patients who presen ted with elevated serum AFP levels, no specific targeting was found an d no malignant lesions were evident by CT or biopsy, One patient was d iagnosed as false-negative by AFP-Scan, In five of six patients with n ormal serum AFP levels, focal uptake was demonstrated, In one case, me tastatic disease in the lower abdomen was found, In all patients, diag nostically relevant information was provided by the 24-hour antibody i mages, especially with SPECT. Comparing AFP-Scan versus CT, the former showed a higher sensitivity (95% v 63%) and specificity (67% v 17%), with an overall accuracy of 88% versus 52% for AFP-Scan versus CT, eve n in patients with normal serum AFP titers, No adverse reactions or hu man antimouse antibody (HAMA) elevations were found in any of the pati ents, Conclusions: AFP-Scan appears to be a promising new antibody ima ging kit for the disclosure of sites of HCC and should aid in the mana gement of these patients by revealing primary, recurrent, and metastat ic disease with a single imaging modality. (C) 1997 by American Societ y of Clinical Oncology.