Trials and tribulations: oncological antibody imaging comes to the fore.
At the present time, there are three radiolabeled antibodies that have been approved by the US Food and Drug Administration (FDA) for imaging of cancer, a fourth commercially sponsored product recommended for approval (as of 10/29/96, cap romab pendetide (ProstaScint; Cytogen Corp., Princeton, NJ) was upgraded from recommended for approval to approved), and several additional agents in FDA-monitored trials. The majority of antibodies studied to date have been whole or fragmented murine monoclonals whereas the first of the human and humanized immunoglobulins are now entering clinical trials. While no antibody has behaved as a perfect imaging agent, they have consistently been shown to contribute to diagnosis, complementing and often exceeding the diagnostic ability of conventional modalities. Many promising new trends in antibody imaging, relating to the radiolabeled immunoglobulin, its route and manner of administration, and mode of detection, are under development. Because of the requisite several-year delay inherent in the (FDA) testing process, there is a lag before the most-promising of these innovations will achieve (FDA) approval and be incorporated into routine imaging studies. In spite of this effective performance, as "new kid on the block," radioimmunoscintigraphy may have often been expected to perform in an unrealistic manner, considering the great variation in biological behavior of primary and metastatic cancer and the consequent limitation of all diagnostic tests. Nonetheless, because radioimmunoscintigraphy identifies antigens on a cellular level, differing fundamentally from anatomic imaging modalities such as computed tomography and ultrasound which identify gross morphological changes, it has potential to impact significantly on patient care. With adequate resources focused on radioimmunoscintigraphy, this technology will continue to emerge as an important and unique diagnostic tool in the care of cancer patients, with demonstrable clinical efficacy and cost effectiveness.
Zuckier
L S
LS
Department of Nuclear Medicine, Albert Einstein College of Medicine, Bronx, NY 10461, USA.
DeNardo
G L
GL
D000818:Animals; D002986:Clinical Trials as Topic; D017277:Drug Approval; D005260:Female; D006801:Humans; D008297:Male; D051379:Mice; D009369:Neoplasms / Q000000981:diagnostic imaging*; D016719:Radioimmunodetection / Q000639:trends; D014481:United States; D014486:United States Food and Drug Administration