Compositions, devices and kits for selective internal radiation therapy

Inventors

Amato, Antonino • Paganelli, Giovanni

Assignees

Betaglue Technologies SpA • Betaglue Technologies SpA

Abstract

Systems, kits and methods for preparing an injection system and/or treating target lesions with a selective internal radiation therapy which includes a double-barrel syringe loaded with a two-component tissue glue and radioisotope loaded microspheres. The microspheres are loaded into the syringe based on the size of the target location and are administered with a needle or dual-lumen catheter. Dosing regimens for treating breast cancer lesions or surgical beds up to 130 mm in diameter and hepatocellular carcinoma lesions up to 50 mm are included.

Core Innovation

The patent describes determining an average tumor size of a tumor lesion, selecting a 90Y syringe activity level using the average tumor size, and loading a dual chamber syringe with the selected 90Y syringe activity level. The dual chamber syringe comprises a first chamber pre-loaded with bovine serum albumin and a second chamber pre-loaded with glutaraldehyde, and loading comprises loading the 90Y syringe activity level into the first and second chambers in a 4:1 ratio.

The patent further provides tumor-diameter-to-activity mappings in MBq, dual chamber syringe sizing and combined volume constraints associated with lesion sizes, and chamber-level loading in subvolumes according to average tumor size and diameter ranges. It also describes adjusting a concentration of a 90Y source before withdrawing a selected 90Y syringe activity level and radio-protective handling of the dual chamber syringe during loading.

The patent additionally documents tabulated example dosing and volume relationships for a 90Y-BIOGLUE matrix dual-chamber syringe across tumor-bed radius ranges, including nominal activity, allocated subvolume distributions, combined volumes, concentration, residual activity, and injected activity. It also describes a first-in-human ablate-resect hepatocellular carcinoma pilot study using the dual-chamber syringe, including feasibility aims, endpoints, eligibility criteria, and imaging and dosimetry assessments based on PET imaging at 24 to 48 h.

Claims Coverage

The document identifies one independent claim directed to preparing a therapy by linking average tumor size to a selected 90Y syringe activity level and loading that activity into a dual chamber syringe with bovine serum albumin in a first chamber and glutaraldehyde in a second chamber using a 4:1 loading ratio. Dependent claims further specify tumor-diameter-to-activity mappings, syringe and volume constraints, chamber subvolume allocations, 90Y source concentration adjustment, and radio-protective handling.

Overall, the claim coverage centers on preparing a therapy by correlating average tumor size with a selected 90Y syringe activity level and loading that activity into a dual chamber syringe with BSA in a first chamber and glutaraldehyde in a second chamber using a 4:1 chamber loading ratio, with additional claim features tied to tumor-diameter mappings, volume constraints, and handling refinements.

Stated Advantages

Documented Applications