Compositions, devices and kits for selective internal radiation therapy
Inventors
Amato, Antonino • Paganelli, Giovanni
Assignees
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Publication Number
US-11464897-B2
Publication Date
2022-10-11
Expiration Date
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 invention relates to selective internal radiation therapy (SIRT) or SIRTx using 90Y-loaded microspheres delivered by a double-barrel syringe or dual chamber syringe. The syringe mixes two components of a tissue glue matrix with 90Y-loaded microspheres at the time of injection to form a treatment material for a tumor lesion, and the described system includes radiopaque/handling components and catheter delivery elements to enable injection at a treatment site.
A central aspect is determining an average tumor size and selecting a 90Y syringe activity level and a corresponding 90Y treatment activity level based on the average tumor size. The disclosed approach links tumor lesion diameter ranges to specific 90Y treatment activity levels, including prescribed activity values for tumors having diameters up to 50 mm, and then uses the selected activity level to load the syringe and inject it to treat the lesion.
The document further addresses dosimetry modeling for small lesions, stating that standard MIRD analytic absorbed-dose calculations overestimate absorbed dose in very small lesions compared with Monte Carlo. It proposes a lesion-radius-dependent absorbed-dose model to support dosimetry for small lesion sizes, and describes imaging-based evaluation of distribution and necrosis.
Claims Coverage
The independent claim coverage centers on a tumor-treatment method that selects a 90Y treatment activity level from tumor size, loads that selected 90Y activity into a dual chamber syringe containing bovine serum albumin and glutaraldehyde, and injects the selected activity at the tumor lesion treatment site. The inventive features are organized around diameter-to-activity mapping and a specific dual-chamber syringe configuration.
Tumor size-based 90Y treatment activity selection
Determining an average tumor size of a tumor lesion and selecting a 90Y syringe activity level and a 90Y treatment activity level using the average tumor size, with diameter-based mapped activity values up to 50 mm.
Dual chamber syringe pre-loaded with bovine serum albumin and glutaraldehyde
Loading a dual chamber syringe with the selected 90Y syringe activity level, wherein the dual chamber syringe comprises a first chamber pre-loaded with bovine serum albumin and a second chamber pre-loaded with glutaraldehyde.
Injecting selected 90Y treatment activity at the tumor lesion treatment site
Injecting the selected 90Y treatment activity level at a treatment site of the tumor lesion using the dual chamber syringe.
Across the independent claim, the inventive coverage centers on diameter-based selection of a 90Y treatment activity level, use of a dual chamber syringe with bovine serum albumin and glutaraldehyde chambers pre-loaded for loading the selected 90Y syringe activity level, and injection of the selected 90Y treatment activity at the tumor lesion treatment site.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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