US-12625281-B2 - System and method for the detection of gamma radiation from a radioactive analyte and providing real time administration feedback

US12625281B2US 12625281 B2US12625281 B2US 12625281B2US-12625281-B2

Abstract

A system and method for the measurement of radiation emitted from an in-vivo administered radioactive analyte. Gamma radiation sensors may be used to determine the proper or improper administration of a radioactive analyte, and provide real time feedback to an autoinjector or other administration device or person. The feedback may include identification of an infiltration event and/or a likelihood that an infiltration event resulted in a radiation dose to a patient above a certain value, among other things.

Inventors

Joshua G. Knowland
Charles W. Scarantino
Ronald K. Lattanze
Steve Perrin

Assignees

LUCERNO DYNAMICS, LLC

Dates

Publication Date: 20260512
Application Date: 20240716

Claims (20)

1 . A system for providing real-time feedback to an auto-injection system during administration of a radioactive analyte that decays in vivo, the system comprising: at least one ex vivo gamma radiation measurement sensor to detect gamma radiation and to produce signal data, the ex vivo measurement sensor adapted to sensing gamma radiation proximate to a point of administration of the radioactive analyte on a subject; a signal amplifier in operable communication with the gamma radiation sensor, the signal amplifier adapted to amplify the signal data; at least one computer processor and a non-transient memory, the computer processor in operable communication with the non-transient memory and the amplified signal data; wherein the non-transient memory includes computer program code executable by the at least one computer processor, the computer program code configured for performing the steps of receiving the amplified signal data, accessing reference data corresponding to an administration protocol, comparing the amplified signal data to the reference data to determine a likelihood of improper administration of the radioactive analyte to the subject, and communicating an administration status to the auto-injection system.
2 . The system of claim 1 , wherein the radioactive analyte being administered is a therapeutic drug or a diagnostic drug.
3 . The system of claim 1 , wherein the administration protocol comprises one or more protocols for placement of one or more of the at least one sensors, administration location, analyte injection rate, analyte injection dose, analyte administration device, type of radioactive analyte being administered, needle gauge used to administer the radioactive analyte, one or more patient characteristics, and saline line flush.
4 . The system of claim 3 , wherein the one or more patient characteristics comprise one or more of patient weight, height, age, body-mass index, patient sex, patient hydration, patient movement during administration, blood pressure, and blood-glucose.
5 . The system of claim 1 , wherein the administration status comprises a presence or absence of an infiltration.
6 . The system of claim 5 , wherein the administration status comprises a likelihood that infiltrated radioactive analyte will result in a radiation dose to the subject above a predetermined value.
7 . The system of claim 1 , wherein the administration status comprises a presence or absence of the radioactive analyte at an intended location.
8 . The system of claim 1 , wherein the amplified signal data is transmitted from a measurement sensor output.
9 . A method for providing real-time feedback to an auto-injection system during administration to a subject of a radioactive analyte that decays in vivo, the method comprising: (i) applying at least one ex vivo gamma radiation measurement sensor proximate to a point of administration on the subject of the radioactive analyte; (ii) detecting gamma radiation over a desired period of time and producing signal data associated with the desired period of time; (iii) amplifying the signal data using a signal amplifier in operable communication with the ex vivo gamma radiation measurement sensor and outputting the amplified signal data; (iv) processing the amplified signal data using a computer processor in operative communication with a non-transient memory by performing the steps of: (a) receiving the amplified signal data associated with the desired period of time; (b) from the non-transient memory, accessing reference administration factors and reference data distributed over a reference period of time; (c) comparing the amplified signal data to the reference data and reference administration factors to determine a likelihood of improper administration of the radioactive analyte to the subject; and (d) communicating an administration status to the auto-injection system.
10 . The method of claim 9 wherein the reference administration factors comprise one or more of an identity of an individual overseeing administration of the radioactive analyte, a method of administration of the radioactive analyte, a dose of radioactive analyte administered, a type of radioactive analyte, a type of autoinjector device used to administer radioactive analyte, an amount of time the autoinjector device used to administer radioactive analyte is in place, a needle gauge used to administer the radioactive analyte, a flush volume used in conjunction with the administration of the radioactive analyte, a location of administration of the radioactive analyte, an orientation of administration of the radioactive analyte, a type of patient therapy, and one or more patient characteristics.
11 . The method of claim 10 , wherein the patient characteristics comprise one or more of patient weight, height, age, body-mass index, patient sex, patient hydration, patient movement during administration, blood pressure, and blood-glucose.
12 . The method of claim 9 further comprising receiving one or more patient administration factors and comparing the one or more patient administration factors to the reference data and reference administration factors for determining the likelihood of improper administration of the radioactive analyte to the subject.
13 . The method of claim 12 wherein the patient administration factors comprise one or more of an identity of an individual overseeing administration of the radioactive analyte, a method of administration of the radioactive analyte, a dose of radioactive analyte administered, a type of radioactive analyte, a type of autoinjector device used to administer radioactive analyte, an amount of time the autoinjector device used to administer radioactive analyte is in place, a needle gauge used to administer the radioactive analyte, a flush volume used in conjunction with the administration of the radioactive analyte, a location of administration of the radioactive analyte, an orientation of administration of the radioactive analyte, a type of patient therapy, and one or more patient characteristics.
14 . The method of claim 13 , wherein the patient characteristics comprise one or more of patient weight, height, age, body-mass index, patient sex, patient hydration, patient movement during administration, blood pressure, and blood-glucose.
15 . The method of claim 9 , wherein the administration status comprises a presence or absence of an infiltration.
16 . The method of claim 15 , wherein the administration status comprises a likelihood that infiltrated radioactive analyte will result in a radiation dose to the subject above a predetermined value.
17 . The method of claim 9 , wherein the administration status comprises a presence or absence of the radioactive analyte at an intended location.
18 . A method for providing real-time feedback to an administrator of a radioactive analyte that decays in vivo to a subject, the method comprising: (i) applying at least one ex vivo gamma radiation measurement sensor proximate to a point of administration on the subject of the radioactive analyte; (ii) detecting gamma radiation over a desired period of time and producing signal data associated with the desired period of time; (iii) amplifying the signal data using a signal amplifier in operable communication with the ex vivo gamma radiation measurement sensor and outputting the amplified signal data; (iv) processing the amplified signal data using a computer processor in operative communication with a non-transient memory by performing the steps of: (a) receiving the amplified signal data associated with the desired period of time; (b) from the non-transient memory, accessing reference administration factors and reference data distributed over a reference period of time; (c) comparing the amplified signal data to the reference data and reference administration factors to determine a likelihood of improper administration of the radioactive analyte to the subject; and (d) communicating an administration status to the administrator.
19 . The method of claim 18 wherein the reference administration factors comprise one or more of an identity of an individual overseeing administration of the radioactive analyte, a method of administration of the radioactive analyte, a dose of radioactive analyte administered, a type of radioactive analyte, a type of autoinjector device used to administer radioactive analyte, an amount of time the autoinjector device used to administer radioactive analyte is in place, a needle gauge used to administer the radioactive analyte, a flush volume used in conjunction with the administration of the radioactive analyte, a location of administration of the radioactive analyte, an orientation of administration of the radioactive analyte, a type of patient therapy, and one or more patient characteristics.
20 . The method of claim 18 further comprising receiving one or more patient administration factors and comparing the one or more patient administration factors to the reference data and reference administration factors for determining the likelihood of improper administration of the radioactive analyte to the subject.

Description

PRIORITY The present application is a continuation of U.S. application Ser. No. 18/142,382 filed May 2, 2023, which is a continuation of U.S. application Ser. No. 17/083,875 filed Oct. 29, 2020, now U.S. Pat. No. 11,668,844, which is a continuation of U.S. application Ser. No. 15/885,112 filed on Jan. 31, 2018, now U.S. Pat. No. 10,852,446, which is a divisional of U.S. application Ser. No. 14/678,550 filed on Apr. 3, 2015, now U.S. Pat. No. 9,939,533, which is a continuation-in-part of U.S. application Ser. No. 13/840,925 filed on Mar. 15, 2013, now U.S. Pat. No. 9,002,438, which claims the benefit of priority to U.S. Provisional Application No. 61/653,014, filed on May 30, 2012, each of which are hereby incorporated herein by reference in their entirety. STATEMENT REGARDING GOVERNMENT SUPPORT None. FIELD OF THE INVENTION The present invention relates to measurement and prediction of biological processes, and more particularly to a system and method for using localized radio-labeled tracer temporal uptake to measure and predict biological processes, and ensuring the proper injection or administration of radio-labeled tracer and providing real time feedback to administration professionals and/or other administration systems. BACKGROUND Oncologists are interested in knowing if the prescribed cancer therapy is having the intended effect, in order to improve outcomes, minimize side effects, and avoid unnecessary expenses. Cytotoxic treatments kill tumor cells. Cytostatic treatments inhibit cell growth leaving tumors the same size, but preventing the spread of the disease. Cytostatic treatments inhibit cell growth leaving tumors the same size, but preventing the spread of the disease. Immunotherapy treatments use the body's immune system to attack the cancer and initially result in an inflammatory response in the tumor area before there is evidence that the body is effectively attacking the tumor. Historically, measuring the tumor has been the primary way for oncologists to assess treatment effectiveness; however, we now understand that the size of the tumor is often not the best or earliest indicator of the therapy effectiveness. With cytotoxic treatment the tumor size reduction only occurs after cancer cells die and the body's natural processes eliminate dead cells; this process can often take weeks. With cytostatic treatment, cancer cells stop growing leaving the clinician unsure of the state of the underlying cancer. With immunotherapy, the body's inflammatory response often masks the tumor from proper evaluation. The tools available to oncologists and researchers today to assess tumor response to treatments are not ideal. Palpating the tumor is easy and inexpensive, but it is limited to tumors close to the surface, relies on a physician's memory and notes, and primarily measures size. The lack of reproducibility of this palpating process, coupled with historical reasons, contributed to the initial acceptance of significant changes in tumor size as an indicator of therapy assessment. Wolfgang A. Weber, et al., “Use of PET for Monitoring Cancer Therapy and for Predicting Outcome,” 46 J. Nucl. Med. (No. 6) 983-995 (June 2005). Imaging tools (CT, MRI, x-ray) provide more precise measurements for tumors both close to the surface and in deep tissue, but again primarily measure size, not the ideal indicator. Molecular imaging (PET/CT scan) captures the positron emissions from injected radio-labeled tracers captured by live cancer cells and is routinely used for pre-therapy staging of cancer. Visually identifying metastatic disease is the primary means of staging cancer; however, a semi-quantitative PET/CT measurement known as Standardized Uptake Value (SUV) is also being used to stage cancer. For example, SUVs are used to help determine whether or not lung nodules are malignant. SUVs are basically a ratio of the amount of radio-labeled tracer in an area of interest (tumor) compared to the level in the rest of the body. While molecular imaging is a primary tool for the pre-therapy need to stage a patient's cancer, it is also rapidly becoming the most advanced tool for oncologists and researchers to assess tumor response, since molecular imaging can capture the metabolic or proliferative condition of the cancer and the size of the tumor. Using an SUV taken from the PET images acquired approximately 60-minutes after injection or administration of a radio-labeled tracer in the staging scans and then comparing this value to an SUV from a follow-up PET/CT is currently the best available indicator for therapy effectiveness. Despite the increasing trend to use comparative PET/CT scans in assessing tumor response in more and more cancer types as clinical evidence continues to grow, there are still limitations with this state of the art assessment tool. PET/CT scans are expensive and their use is often challenged. Additionally, there are several issues with SUV calculations. According to Dr. Dominique Delbeke: “[t]he repro