Introduction

The patent concerns a new microdispersed system, suitable for radiolabelling with long-lived radioisotopes, for application in localization and therapeutic treatment of precancerous breast lesions. The product would let schedule surgery on several days, reducing the time and cost of hospitalization, and might also be employed in the localization of other forms of cancer.

Technical features

ROLL is a technique that allows the precocious localization and removal of non-palpable breast lesions by means of radioactive tracers. Due to the short half-life of the radionuclide used (m99Tc) so far, it does not allow appropriate planning of surgery, and the application of longer-lived isotopes is not feasible. This patent concerns a novel microdispersed system, based on human albumin, insoluble in aqueous environment, suitable for radiolabeling with long-lived radioisotopes (177Lu or 111In), useful for both localization and therapeutic treatment preceding surgery. The product can be obtained, in suspension or lyophilized, as a sterile material, is stable to radiolabeling, and is retained for long time in living tissues. The new product would allow to schedule surgery on several days, increasing the number of feasible interventions, and might also be employed in the localization of other forms of cancer.

Possible Applications

• Localization, for the subsequent surgery, of precancerous breast lesions or other solid tumors (prostate, head and neck, etc.).

Advantages

• Straightforward chemistry;
• Suitable for long-lived radioisotopes;
• Product already fully characterized;
• Production process easily scalable;
• Aseptic manufacturing;
• Stability to radiolabeling and in living tissues confirmed;
• Starting material commercially available at low cost.