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Tumor Immunoscintigraphy by Means of Radiolabeled Monoclonal Antibodies

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Tumor Immunoscintigraphy by Means of Radiolabeled Monoclonal Antibodies [CANCER RESEARCH (SUPPL.) 50, 899s-903s. February I. 1990] Tumor Immunoscintigraphy by Means of Radiolabeled Monoclonal Antibodies: Multicenter Studies of the Italian National Research Council—Special Project "BiomédicalEngineering"l Antonio G. Siccardi Dipartimento di Biologia e Genetica per le Scienze Mediche, Università di Milano, Via Viotti 3/5, 20133 Milan, Italy Abstract configuration(s); and (d) pilot studies on tumor imaging, spec Four radioimmunopharmaceuticals ("'""Ir- and "'In-labeled anti-mel ificity tests, and comparisons between differently labeled re anoma and '"In- and 13ll-labeled anti-carcinoembryonic antigen I (ali')., agents. Stage 1 required the collaboration of several groups: S. Ferrane and coworkers at the Department of Microbiology and fragments derived from monoclonal antibodies 225.28S and F023C5) Immunology, New York Medical College, Valhalla, NY; M. were developed by means of a collaborative effort coordinated by the Italian National Research Council, Special Project "Biomedicai Engi Dovis and coworkers at the Research Center of Sorin Biome neering." After appropriate pilot studies, the radioimmunopharmaceuti dica; and P. G. Natali and coworkers at the Istituto Tumori cals, prepared by Sorin Biomedica (Saluggia, Italy), were distributed to Regina Elena, Rome, Italy. Stages 2, 3, and 4 were carried out 31 Nuclear Medicine departments in Italy and in 10 other European by L. Callegaro, G. Deleide, and coworkers at the Research countries within the framework of three immunoscintigraphy multicenter Center of Sorin Biomedica, Saluggia, Italy; by G. Mariani and studies. A total of 1245 patients were studied, 898 of whom carried 1725 coworkers at the CNR Institute of Clinical Physiology, Pisa, documented tumor lesions; 1596 of 2193 tumor lesions (468 of which Italy; by G. L. Buraggi and coworkers at the Istituto Nazionale were previously unknown) were imaged by immunoscintigraphy in 785 of Tumori, Milan, Italy; and by P. Riva and coworkers at the 990 lesion-bearing patients. Among the occult lesions, 173 were imaged in 92 patients admitted to the study as lesion-free patients. The results Ospedale Bufalini, Cesena, Italy. G. A. Scassellati of Sorin have been analyzed in terms of the reliability, reproducibility, and diag Biomedica coordinated the industrial side of the program. This report summarizes the results of three multicenter stud nostic usefulness of the method and of each immunoradiopharmaceutical. ies, the first of which, the Italian section of "ISG of Human Melanoma," was completed in 1985 (15); the second, "ISG of Introduction CEA-secreting Carcinomas" was completed in 1987 (16); and The aim of the Special Project "Biomedicai Engineering" the third, the European section of the melanoma study, was (1982-1987; directed by L. Donato) was to promote product- completed in 1988(17). The principal investigators of the 31 Nuclear Medicine de oriented research in collaboration with Italian industries oper ating in the biomedicai area. Tumor ISG,2 in its pioneering partments involved in the multicenter studies were: A. Abbati stages in 1982 (1-3), was included in the project as a potential (Ospedale Maggiore, Bologna, Italy), M. Bestagno (Spedali field of development. A coordinated program was set up to (a) Civili, Brescia, Italy), D. Bockisch (Institut fürKlinische und Experimentelle Nuklearmedizin der Universität, Bonn, West evaluate the feasibility and the effectiveness of the method in Germany); K. E. Britton (St. Bartholomew's Hospital, London, pilot studies, (b) develop standardized reagents (IRP) of indus trial quality suitable for routine clinical use, and (c) perform United Kingdom), U. Bull (Klinikum Aachen, Aachen, West Germany), G. L. Buraggi (Istituto Nazionale Tumori, Milan, multicenter studies in Italy and other countries, in order to Italy), V. Caputo (Università "La Sapienza," Rome, Italy), A. evaluate the reproducibility and reliability of the developed Centi Colella (Policlinico "Umberto I," Rome, Italy), T. Cerny products and their clinical diagnostic usefulness. Industrial IRPs derived from two monoclonal antibodies, the and S. Owens (Christie Hospital and Holt Radium Institute, anti-melanoma 225.28S and the anti-CEA F023C5, were de Manchester, United Kingdom), A. Crespo Diez (Centra Ramon veloped by Sorin Biomedica, Saluggia, Italy, with the collabo Y Cajal, Madrid, Spain), R. Dudczak (Medizinische Universi ration of several University and National Research Council tätklinik,Wien, Austria), J. J. Duque (Hospital de Cruces de laboratories, the Nuclear Medicine Department of the Istituto Barcaldo, Bilbao, Spain), M. Füzy(National Institute of On Nazionale Tumori of Milan, and other institutions (4-14). The cology, Budapest, Hungary), G. Galli (Policlinico Gemelli, products were distributed to 31 Nuclear Medicine departments Università Cattolica, Rome, Italy), D. Garcia Sous (Hospital in Italy and other countries and evaluated extensively in terms Universitario Virgen del Roció, Seville, Spain), J. Y. Herry of diagnostic application and usefulness on more than 1200 (Centre Eugene Marquis, Rennes, France), A. T. Irvine (The patients. Royal Marsden Hospital, London, United Kingdom), K. Liew- The research stages to be undertaken prior to the evaluation endahl (Department of Clinical Chemistry, University of Hel of IRPs in large-scale clinical trials are common to all projects sinki, Finland), M. Martinez-Paredes (Cátedra de Radiologia, of this kind: (a) the choice of suitable, well-characterized anti Facultad de Medicina, Universidad de Córdoba, Córdoba, gen-antibody systems; (b) immunochemical and radiochemical Spain), R. Masi (Ospedale Careggi, Florence, Italy), A. No- studies to prepare various types of immunoglobulin fragments gueira (Instituto Portuguésde Oncologia Francisco Gentil, labeled with a number of radioisotopes; (c) biodistribution Lisboa, Portugal), E. Pittelkow (Klinikum der Universität,Hei studies in animals and humans to choose the most appropriate delberg, West Germany), M. Rentsch (Institut fürMedizinische Onkologie der Universität, Inselspital, Bern, Switzerland), P. 1Presented at the "Second Conference on Radioimmunodetection and Ra- dioimmunotherapy of Cancer." September 8-10, 1988, Princeton. NJ. Riva (Ospedale Bufalini, Cesena. Italy), M. Salvatore (Istituto 2The abbreviations used are: ISG. immunoscintigraphy; CEA, carcinoem- Pascale, Naples, Italy), M. Sanguineti (Ospedali Galliera. bryonic antigen; CT, computerized tomography; F(ab');, bivalent fragments of Genoa, Italy), K. Scheidhauer (Klinikum Grosshadern, Univ antibodies obtained by papain digestion: HMW-MAA, high molecular weight melanoma-associated antigen: Mab, monoclonal antibody; IRP, immunoradi ersität,Munich, West Germany), B. Siwek (Zaklad Medycyny opharmaceutical; US, ultrasound tomography: i.d.. intradermally. Nuklearnej, Lublin, Poland), I. Szilvási (Department of Ra- 899s Downloaded from cancerres.aacrjournals.org on September 26, 2021. © 1990 American Association for Cancer Research. TUMOR IMMUNOSCINTIGRAPHY WITH RADIOLABELED Mabs diology, Postgraduate Medical School, Budapest, Hungary), G. The localization of radiolabeled reagents in tumor lesions L. Turco (Università di Torino, Turin, Italy), and P. Zaniol was demonstrated to be antigen specific, since it was shown to (Università di Modena, Modena, Italy). More than 100 physi be quite different from the distribution of radiolabeled frag cians, in the above departments, were actively involved in the ments of monoclonal antibody 4C4 (reactive with an irrelevant multicenter studies. viral antigen) in all patients investigated; 15 melanoma patients and 12 carcinoma patients were subjected to this kind of "dou ble-tracer" ISG specificity test. Materials and Methods In other cases, the anti-melanoma IRP were used as specific Monoclonal Antibodies. The anti-melanoma Mab 225.28S, reactive ity control in carcinoma patients and vice versa. A representative with the high molecular weight melanoma associated antigen (HMW- example (14) follows. Four patients, who had shown positive MAA) was developed by Wilson et al. (18) and characterized extensively imaging of carcinoma lesions by the '"In-labeled anti-CEA (see Ref. 14 for a collection of the relevant references). Its applications F(ab')2, were injected, after 3 weeks, with equal amounts of in ISG have been reported (4-7). The anti-CEA Mab F023C5, reactive '"In-labeled (in 2 cases) or "Tc-labeled (in 2 cases) F(ab')2 with the protein portion of CEA and unreactive with human granulo- fragments of the anti-melanoma monoclonal antibody. No im cytes, was developed by Dovis and collaborators and has been exten aging of carcinoma lesions with the melanoma-specific IRPs sively described, also for its ISG applications (8-14). The anti-hepatitis B virus surface antigen Mab 4C4 (19) was used as a specificity control. was observed; conversely, no imaging of melanoma lesions by the CEA-specific IRP was observed in a complementary study, Immunoradiopharmaceuticals. The following products were devel oped and produced by Sorin Biomedica: (a) kit for instant labeling carried out on four melanoma patients. F (ab')2 fragments of Mab 225.28S with 99nTc; (o) kit for instant A correlation close to 100% between positive ISG imaging labeling F(ab')2 fragments of Mab 225.28S with "'In; (c) kit for instant and the immunocytochemical detection of the relevant tumor- labeling F(ab')2 fragments of Mab F023C5 with '"In; (d) F(ab')2 associated antigen on biopsied tumor tissues was demonstrated. fragments of
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