Methods, systems, and associated implantable devices for radiation dose verification for therapies used to treat tumors

• US 6,963,771 B2
• Filed: 09/04/2003
• Issued: 11/08/2005
• Est. Priority Date: 09/30/1998
• Status: Expired due to Term

• Current Assignee: SNC Holdings Corp.
• Original Assignee: Sicel Technologies, Inc., North Carolina State University (University of North Carolina System)
• Inventors: Mueller, Jeffrey, Nagle, H. Troy, Scarantino, Charles W., Hall, Lester C.
• Primary Examiner(s): Winakur, Eric F.
• Application Number:
  US10/655,317
• Publication Number:
  US 20040230115A1
• Time in Patent Office: 796 Days
• Field of Search: 600/436, 600/302, 128/903, 378/65
• US Class Current: 600/436
• CPC Class Codes: A61B 2562/028 Microscale sensors, e.g. electromechanical sensors [MEMS]
• CPC Class Codes: A61B 2562/085 combined with means for recording calibration data
• CPC Class Codes: A61B 5/0031 Implanted circuitry
• CPC Class Codes: A61B 5/14539 for measuring pH
• CPC Class Codes: A61B 5/1473 invasive, e.g. introduced into the body by a catheter A61B5/1482 takes precedence
• CPC Class Codes: A61B 5/1486 using enzyme electrodes, e.g. with immobilised oxidase
• CPC Class Codes: A61B 5/14865 invasive, e.g. introduced into the body by a catheter or needle or using implanted sensors
• CPC Class Codes: A61B 5/1495 Calibrating or testing of in-vivo probes
• CPC Class Codes: A61B 5/417 the bone marrow
• CPC Class Codes: A61B 6/507 for determination of haemodynamic parameters, e.g. perfusion CT
• CPC Class Codes: A61N 5/1048 Monitoring, verifying, controlling systems and methods
• CPC Class Codes: A61N 5/1071 for verifying the dose delivered by the treatment plan
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/67 for remote operation
• CPC Class Codes: Y10S 128/903 Radio telemetry
• CPC Class Codes: Y10S 128/904 Telephone telemetry
• CPC Class Codes: Y10S 128/92 Computer assisted medical diagnostics

Abstract

Methods and systems for evaluating external beam radiation therapy delivered to a subject include: (a) placing at least one wireless implantable sensor in a first subject at a target location; (b) administering a first dose of radiation therapy into the first subject; (c) obtaining radiation data from the at least one wireless implantable sensor; and (d) calculating a radiation dose amount received by the first subject at the target location based on the radiation data obtained from the at least one wireless sensor during and/or after exposure to the first administered dose of radiation to determine and/or verify a dose amount of radiation delivered to the target location.

Claims

1. A method for evaluating external beam radiation therapy delivered to a subject, comprising:

placing at least one wireless implantable sensor in a first subject at a target location;

administering a first dose or sub-dose amount of external beam radiation therapy into the first subject, wherein the implantable sensor comprises a radiation sensor that is unpowered during exposure to ionizing radiation associated with he administering step;

obtaining radiation data from the at least one wireless implantable sensor; and

calculating a radiation dose amount received by the first subject at the target location based on the radiation data obtained from the at least one wireless sensor during and/or after exposure to the first administered dose of the radiation therapy to determine and/or verify a dose amount of radiation delivered to the target location.

2. A method according to claim 1, wherein the radiation therapy comprises a high dose conformal radiation therapy.

3. A method according to claim 1, wherein the radiation therapy comprises gamma radiation therapy.

4. A method according to claim 1, wherein the radiation therapy comprises x-ray radiation therapy.

5. A method according to claim 1, wherein the radiation therapy comprises photon radiation therapy.

6. A method according to claim 1, wherein the radiation therapy comprises electron radiation therapy.

7. A method according to claim 1, wherein a predetermined planned therapeutic dose amount for a single therapy session is less than about 400 cG.

8. A method according to claim 1, said method further comprising comparing a predicted and/or planned delivered dose to the calculated dose to confirm or verify that a proper dose amount was received at the target location in the subject.

9. A method according to claim 8, further comprising adjusting the focal depth, direction, and/or or amount of the external radiation administered based on said comparing step and/or the calculated delivered internal radiation dose.

10. A method according to claim 9, wherein the first subject is a phantom used to plan a radiation therapy.

11. A method according to claim 10, further comprising:

placing at least one wireless implantable sensor in vivo in a second subject at a target location corresponding to the target location in the first subject, wherein the implantable sensor comprises a radiation sensor that is unpowered during exposure to ionizing radiation associated with the administering step;

administering a second dose of external beam radiation to the second subject;

obtaining radiation data from the at least one wireless implantable sensor in the second subject; and

calculating a radiation dose amount received by the second subject at the target location based on the radiation data obtained from the at least one wireless sensor during and/or after exposure to the second administered dose of radiation to determine and/or verify whether a dose amount of external beam radiation delivered to the target location corresponds to the first dose amount delivered to the target location in the first subject.

12. A method according to claim 11, wherein the second subject is mammalian.

13. A method according to claim 11, wherein the second subject is human.

14. A method according to claim 11, wherein the placing at least one implantable sensor comprises placing a plurality of sensors at different depths and/or locations in the second subject.

15. A method according to claim 8, further comprising adjusting a planned radiation treatment dose based on the comparing step.

16. A method according to claim 1, wherein the target location in the subject is proximate a simulated tumor depth.

17. A method according to claim 1, further wherein said implantable sensor unit includes sensor electronics, and wherein said method further comprises the step of adjusting the radiation data transmitted from the wireless sensor to account for deviations in the data attributed to electronic drift and/or the sensor'"'"'s exposure to at least one of radiation and temperature.

18. A method according to claim 1, further comprising providing a substantially cylindrically shaped implanted sensor having opposing first and second ends, and wherein said sensor includes an inductively coupled power source.

19. A method according to claim 18, wherein said sensor is sized and configured to be injectable via a trochar into a subject such that at least one of said first and second ends contacts a tumor within a mammalian body.

20. A system for evaluating external beam radiation therapy delivered to a subject, comprising:

at least one wireless implantable radiation sensor adapted to be placed subsurface in a subject at a target location, wherein the implantable sensor comprises a radiation sensor that is unpowered during exposure to ionizing radiation; and

a reader operatively associated with the at least one wireless sensor, the reader configured to;

(a) wirelessly communicate with the at least one sensor;

(b) analyze radiation data telemetrically obtained from the at least one wireless implantable sensor; and

(c) calculate the radiation dose amount received by the subject at the target location based on the radiation data obtained from the at least one wireless sensor during and/or after exposure to the external beam radiation therapy to verify that a desired planned dose amount of external beam radiation is delivered to the target location.

21. A system according to claim 20, further comprising an external beam radiation source configured to deliver a radiation dose to the target location.

22. A system according to claim 20, wherein said implantable wireless radiation sensor is configured as a substantially cylindrically shaped body having opposing first and second ends, and wherein said sensor includes an inductively coupled power source operated by said reader.

23. A system according to claim 20, wherein the at least one implantable radiation sensor comprises a plurality of implantable radiation sensors, and wherein the reader is configured to obtain radiation data from each of the plurality of implantable sensors.

24. A system according to claim 20, wherein the system is adapted to perform dose verification of photon radiation therapy with the implantable sensor positioned in vivo in a patient having a cancerous tumor site.

25. A system according to claim 24, wherein the at least one implantable sensor is configured to be chronically implanted in a human subject.

26. A system according to claim 20, wherein the system is adapted to perform dose verification with the implantable sensor positioned subsurface in a phantom subject at a location corresponding to the tumor site in the patient.

27. A system according to claim 20, wherein the system is configured to develop a planned radiation therapy for a cancer patient.

28. A system according to claim 27, wherein the at least one implantable sensor is positioned in a phantom simulating a target treatment site of a mammalian subject.

29. A system according to claim 20, wherein the at least one implantable sensor is configured to be positioned in a human subject at a tumor site.

30. A computer program product for evaluating external beam radiation therapy delivered to a subject, the computer program product comprising:

a computer readable storage medium having computer readable program code embodied in said medium, said computer-readable program code comprising;

computer readable program code for commencing a first wireless data transmission from an implantable wireless radiation sensor with at least one radiation sensor element, the wireless sensor positioned in a subject at a target location corresponding to an actual or simulated depth and position of a target treatment tumor site to detect a dose of radiation received thereat, wherein the radiation sensor element is unpowered during exposure to ionizing radiation generated by the external beam radiation therapy; and

computer readable program code for calculating a radiation dose amount received by the subject at the target location due to the external beam radiation based on the radiation data obtained from the at least one wireless sensor; and

computer readable program code to determine whether the calculated received dose corresponds to a predetermined planned dose.

31. A method of evaluating an external beam tumor radiation treatment, comprising the steps of:

(a) detecting radiation data corresponding to radiation delivered to a subject from the external beam radiation treatment using at least one implantable wireless sensor positioned at a location corresponding to an actual or simulated tumor site in a subject, wherein the implantable wireless sensor comprises a radiation detector that is unpowered during exposure to radiation from the external beam radiation treatment;

(b) wirelessly transmitting the detected radiation data to a receiver located external to the subject; and

(c) determining the amount of radiation delivered to the tumor site based on the transmitted radiation data.

32. A tumor treatment evaluation system for evaluating an external beam radiation therapy, comprising:

at least one implantable sensor unit configured and sized for placement at a depth and position in a subject that corresponds to a target cancerous tumor treatment site, the sensor configured to detect a therapeutic amount of radiation exposure at the target site, wherein the implantable wireless sensor unit comprises a radiation detector that is unpowered during exposure to radiation from the external beam radiation treatment; and

a remote receiver in wireless communication with said at least one sensor unit, said receiver configured to receive radiation data from the at least one sensor and calculate the therapeutic radiation dose detected by the sensor unit at the target site.