Method and device for radiotherapy

Inventors

Kelson, ItzhakArazi, Lior

Assignees

Alpha Tau Medical Ltd

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Publication Number

US-8894969-B2

Patent

Publication Date

2014-11-25

Expiration Date


Abstract

A radiotherapy method, comprising positioning a predetermined amount of a radionuclide selected from the group consisting of Radium-223, Radium-224, Radon-219 and Radon-220, in proximity to and/or within a tumor of a subject, for a predetermined time period. The predetermined amount and the predetermined time period are selected sufficient for the radionuclide to administering a predetermined therapeutic dose of decay chain nuclei and alpha particles into the tumor.

Core Innovation

The invention relates to radiotherapy using locally positioning short-lived alpha-emitting radionuclides in or near tumors for a selected time period, to deliver a therapeutic dose of decay-chain nuclei and alpha particles of a radionuclide. The described radionuclides include Radium-223 and Radium-224 and their associated decay-chain products, with an option for the radionuclide to be removed after the selected treatment time period.

A radiotherapy device is described that locally positions the radionuclide by using a removable probe adapted to be at least partially introduced into a body. The probe includes an object selected from a needle, a tip of an endoscope, a tip of a laparoscope, or a tip of an imaging device, and a radionuclide selected from Radium-223 and Radium-224 is retainably embedded on or beneath a surface of the object so the radionuclide remains in the probe while the therapeutic dose is emitted outside the probe surface.

The device additionally describes probe configurations intended to confine radionuclide and limit spread, including embodiments with an inner elongated member movable within an outer tubular member having a mouth section and, in some embodiments, a window to enable distal-end protrusion. Radionuclide distribution can be performed by releasing at least a portion of the radionuclide prior to emission, and detection and quantification are described using photoluminescent material and photostimulable phosphor detectors to infer alpha transport behavior in experimental examples.

The document also describes manufacture and experimental validation concepts, including surface-source preparation approaches and manufacture approaches for implanting the radionuclide onto or beneath probe surfaces. Experimental examples include electrostatic embedment on titanium-coated needles, preparation of surface sources to generate decay-chain flux, and in vivo/ex vivo mouse studies using radiolabeled needles with photostimulable phosphor detection to measure signal distances associated with alpha transport, including a B16 melanoma study.

Claims Coverage

The provided set includes four independent claims (device claims): a coated-probe device, an uncoated-probe device, a specific movable inner/outer tubular distal probe arrangement, and an injectable-bead probe arrangement. Across these claims, the coverage centers on retainably embedding Radium-223 or Radium-224 on or beneath a probe surface so decay-chain nuclei and alpha particles are emitted outside the surface during therapeutic delivery, with further claim-specific limitations on protective coating, probe geometry, and optional radionuclide release behavior.

Retainably embedded Radium-223 or Radium-224 on a removable probe surface with non-blocked emission

A removable probe adapted for being at least partially introduced into a body, comprising an object selected from a needle, a tip of an endoscope, a tip of a laparoscope and a tip of an imaging device; and a radionuclide selected from Radium-223 and Radium-224, retainably embedded on or beneath a surface of the object, wherein the embedding ensures that the radionuclide remains in the probe while a therapeutic dose of decay chain nuclei and alpha particles of the radionuclide is emitted outside said surface.

Protective coat selected not to prevent emission

The probe being coated by a protective coat, wherein a thickness and a material of said protective coat is selected so as not to prevent said emission of said decay chain nuclei and said alpha particles.

Uncoated removable probe with embedded Radium-223 or Radium-224

An uncoated removable probe, adapted for being at least partially introduced into a body of a subject, comprising an object selected from a needle, a tip of an endoscope, a tip of a laparoscope and a tip of an imaging device; and a radionuclide selected from Radium-223 and Radium-224, said radionuclide being embedded on or beneath a surface of said object, wherein said radionuclide remains in said probe while a therapeutic dose of decay chain nuclei and alpha particles of said radionuclide is emitted outside said surface.

Movable inner elongated member with distal-end embedded radionuclide in an outer tubular member

A removable probe adapted for being at least partially introduced into a body of a subject, said removable probe located at a distal end of an inner elongated member, said inner tubular member associated with an outer tubular member having a mouth section configured for receiving said inner elongated member, said inner elongated member being movable within said outer tubular member and having a distal end and a proximal end; and a radionuclide selected from Radium-223 and Radium-224, said radionuclide being retainably embedded on or beneath a surface of said distal end, wherein a therapeutic dose of decay chain nuclei and alpha particles of said radionuclide is emitted outside said surface.

Outer tubular member mouth section and movable probe distal access by window

The outer tubular member having at least one window that allows the distal end of an inner elongated member to protrude through it.

Injectable bead with embedded Radium-223 or Radium-224 and protective coat

A removable probe adapted for being at least partially introduced into a body of a subject and comprising at least one object selected from a needle, a tip of an endoscope, a tip of a laparoscope and a tip of an imaging device and an injectable bead; and a radionuclide selected from Radium-223 and Radium-224, said radionuclide being retainably embedded on or beneath a surface of said bead, said embedding ensuring that said radionuclide remains in said probe while a therapeutic dose of decay chain nuclei and alpha particles of said radionuclide is emitted outside said surface.

Protective coat on injectable bead selected not to prevent emission

Said injectable bead being coated by a protective coat, wherein a thickness and a material of said protective coat is selected so as not to prevent said emission of said decay chain nuclei and said alpha particles.

Overall, the independent claim coverage focuses on a radiotherapy device that retainably embeds Radium-223 or Radium-224 on or beneath selected probe surfaces so the radionuclide remains in the probe while therapeutic decay-chain nuclei and alpha particles are emitted outside that surface. Additional independent-claim differentiation includes whether the probe is coated, whether the arrangement uses a movable inner elongated member within an outer tubular member, and whether the probe includes an injectable bead with its own protective coat constraints.

Stated Advantages

Maintains the radionuclide in the probe while emitting therapeutic decay chain nuclei and alpha particles outside the probe surface.

Protective coat thickness and material are selected so as not to prevent emission of the decay chain nuclei and alpha particles.

Enables a distal-end device geometry in which a movable inner elongated member carries retainably embedded radionuclide while emission occurs outside the distal surface.

Allows confinement/local positioning of emitted therapeutic components by embedding the radionuclide on or beneath specific probe surfaces, including on an injectable bead surface.

Documented Applications

Locally positioning short-lived alpha-emitting radionuclides in or near tumors for a selected time period to deliver a therapeutic dose of decay-chain nuclei and alpha particles.

Radiotherapy using probe-based delivery of Radium-223 or Radium-224 embedded on or beneath probe surfaces so emission occurs outside the surface, including embodiments using needle/endoscope/laparoscope/imaging-device tips and an injectable bead.

Use of photoluminescent/phosphor detector readout to infer alpha transport behavior in experimental examples, including in mouse tumor studies (LAPC4 prostate and B16 melanoma).

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