Methods, systems, and associated implantable devices for detecting radiation in patients undergoing treatment for cancer

• US 20050251033A1
• Filed: 07/20/2005
• Published: 11/10/2005
• Est. Priority Date: 09/30/1998
• Status: Active Grant

• 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.
• Granted Patent: US 7,787,937 B2
• Time in Patent Office: Days
• 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 monitoring a tumor site of a patient undergoing treatment for cancer, comprising:

administering a radiolabeled agent to the patient;

detecting in vivo from at least one wireless sensor implanted in solid tissue at a tumor site, a signal corresponding to radiation uptake in the in the solid tissue at the tumor site responsive to the administering step;

relaying the signal to a location external of the patient'"'"'s body; and

determining uptake of the radiolabeled agent in the solid tissue to assess a patient specific response to a cancer treatment strategy and/or evaluate the likelihood of clinical efficacy of the treatment in the patient.

2. A method according to claim 1, wherein the radiolabeled agent comprises a radiolabeled chemotherapeutic drug.

3. A method according to claim 2, further comprising evaluating the patient'"'"'s response to the chemotherapeutic drug based on the determined uptake.

4. A method according to claim 1, further comprising generating a predictive treatment outcome based on the determined uptake.

5. A method according to claim 1, wherein the determining step is carried out in substantially real time proximate in time to the administering step.

6. A method according to claim 1, further comprising excluding certain types of treatment as being unlikely to be clinically effective based on data generated by said determining step.

7. A method according to claim 1, wherein the sensor is a unitary body implantable sensor comprising a MOSFET-based radiation circuit configured to detect radiation, and wherein the sensor is configured to be inductively powered to wirelessly communicate radiation data to an externally located reader.

8. A method according to claim 1, wherein said at least one sensor is a plurality of discrete sensors configured to detect radiation.

9. A method according to claim 1, further comprising detecting radiation from a site away from the tumor site using a second implanted wireless sensor.

10. A method according to claim 1, wherein said determining step is carried out such that the radiation in the region of interest is monitored at least periodically over a period of time extending for at least between about 0.25-48 hours proximate in time to at least one planned and/or delivered therapeutic treatments.

11. A detection system for detecting in vivo uptake of a therapeutic drug at a tumor site, comprising:

at least one wireless chronically implanted radiation sensor configured for in vivo operation, the at least one sensor being configured to detect radiation from an internally administered radiolabeled agent in solid tissue proximate a tumor treatment site in the body, wherein the at least one sensor is inductively powered; and

an external reader operably associated with the at least one radiation sensor, the reader being configured to wirelessly receive signal data associated with radiation detected by the at least one sensor, wherein said system is configured to dynamically monitor selected in vivo parameters associated with uptake of the radiation at the tumor site from the internally administered radiolabeled analyte.

12. A system according to claim 11, wherein the at least one sensor is adapted to reside on and/or in a tumor at a depth in the body of a subject.

13. A system according to claim 11, wherein the at least one sensor is a plurality of discrete sensors, each configured to wirelessly transmit signals associated with the in vivo detected radiation over a plurality of monitoring periods during a treatment regime extending from between about 1 week-3 months.

14. A system according to claim 11, further comprising a second at least one chronically implanted sensor in communication with the external reader, the second at least one sensor configured for in vivo operation to detect radiation from an internally administered radiolabeled agent in solid tissue at a location which is spaced apart from the tumor treatment site in the body, wherein the at least one sensor is inductively powered.

15. A computer program product for evaluating a cancer treatment regimen in a cancer patient, said computer program product comprising a computer readable medium having computer readable program code embodied therein, the computer readable program code comprising:

computer readable program code for operating at least one wireless sensor implanted in solid tissue at a tumor site to obtain a signal corresponding to radiation uptake in the in the solid tissue at the tumor site responsive to an administration of a radiolabled drug; and

computer readable program code for determining uptake of the radiolabeled drug in the solid tissue at the tumor site to assess a patient specific response to a cancer treatment strategy and/or evaluate the likelihood of clinical efficacy of the treatment in the patient.

16. A computer program product according to claim 15, further comprising:

computer readable program code for evaluating a plurality of measurements of radiation detected in vivo in tissue from the chronically implanted sensor; and

computer readable program code for computing a patient specific in vivo prediction of a treatment outcome based on the determined radiation uptake at the tumor site based on the plurality of received measurements.