THE OBJECTIVE OF THIS PHASE I PROJECT IS TO DEVELOP AND EVALUATE A NOVEL METHOD FOR RADIOLABELING MONOCLONAL ANTI- BODIES WITH TECHNETIUM-99M FOR THE SPECIFIC DIAGNOSIS OF CANCER.

THE OBJECTIVE OF THIS PHASE I PROJECT IS TO DEVELOP AND EVALUATE A NOVEL METHOD FOR RADIOLABELING MONOCLONAL ANTI- BODIES WITH TECHNETIUM-99M FOR THE SPECIFIC DIAGNOSIS OF CANCER. THE METHOD PROVIDES FOR A VERY EFFICIENT UPTAKE OF OFFERED TECHNETIUM TO THE HIGH SPECIFIC ACTIVITY REQUIRED FOR RADIOIMAGING. ANTIBODY PREPARED ACCORDING TO THE DESCRIBED METHOD RETAINS MOST OF ITS IMMUNOREACTIVITY, AND NO DETECTABLE DENATURATION OR AGGREGATION IS OBSERVED. STABILITY OF THE PREPARED ANTIBODY IS POOR, HOWEVER; THE ANTIBODY LOSES ITS ABILITY TO COMPLEX TECHNETIUM WITHIN 24 HOURS. THIS PROPOSAL DETAILS TWO POTENTIAL METHODS FOR GAINING THE REQUIRED STABILITY FOR RADIOPHARMACEUTICAL KIT FORMULATION. FURTHER, THE PROPOSAL PROVIDES FOR A THOROUGH EVALUATION OF THE TECHNETIUM LABELED ANTIBODY WITH IN VITRO METHODS AND IN VIVO WITH HUMAN TUMOR XENOGRAPHS IN MICE AND RATS. IF PHASE I EFFICACY CAN BE DEMONSTRATED IN THE ANIMALTUMOR MODELS, THIS WILL SET THE STAGE FOR HUMAN CLINICAL TRIALS TO BE CARRIED OUT IN A PHASE II STUDY.