# US 12,214,219 B2 · Systems and methods for biological adaptive radiotherapy

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- Number: US 12,214,219 B2
- Document ID: US12214219B2
- Status: Granted
- Kind: B2
- Application number: 18/295,448
- Filed: 2023-04-04
- Published: 2023-12-07
- Granted: 2025-02-04
- Earliest claimed: 2017-06-22
- Assignees: RefleXion Medical, Inc.
- Applicants: RefleXion Medical, Inc.
- Inventors: Michael Kirk Owens; Rostem Bassalow; Peter Demetri Olcott; Yevgen Voronenko; David Quentin Larkin; Samuel Mazin
- Web page: https://patentgrep.com/patent/US12214219B2

## CPC

- A61N 5/1031: {using a specific method of dose optimization}
- A61B 6/037: {Emission tomography}
- A61B 6/5217: {extracting a diagnostic or physiological parameter from medical diagnostic data}
- A61N 5/1039: {using functional images, e.g. PET or MRI}
- A61N 5/1049: {for verifying the position of the patient with respect to the radiation beam}
- A61N 5/1064: {for adjusting radiation treatment in response to monitoring}
- A61N 5/1067: {in real time, i.e. during treatment}
- A61N 5/1068: {Gating the beam as a function of a physiological signal}
- A61N 5/1071: {for verifying the dose delivered by the treatment plan}
- A61N 5/1036: {Leaf sequencing algorithms}
- A61N 5/1037: {taking into account the movement of the target, e.g. 4D-image based planning}
- A61N 5/1038: {taking into account previously administered plans applied to the same patient, i.e. adaptive radiotherapy}
- A61N 5/1045: {using a multi-leaf collimator, e.g. for intensity modulated radiation therapy or IMRT}
- A61N 2005/1034: {Monte Carlo type methods; particle tracking}
- A61N 2005/1052: {using positron emission tomography [PET] single photon emission computer tomography [SPECT] imaging}
- A61N 2005/1055: {using magnetic resonance imaging [MRI]}
- A61N 2005/1058: {using ultrasound imaging}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)

## Abstract

Disclosed herein are systems and methods for adapting and/or updating radiotherapy treatment plans based on biological and/or physiological data and/or anatomical data extracted or calculated from imaging data acquired in real-time (e.g., during a treatment session). Functional imaging data acquired at the time of radiation treatment is used to modify a treatment plan and/or dose delivery instructions to provide a prescribed dose distribution to patient target regions. Also disclosed herein are methods for evaluating treatment plans based on imaging data acquired in real-time.

## Claims

### Claim 1

A method for calculating bounded dose-volume histograms (DVH) for evaluating a treatment plan, the method comprising:
generating a plurality of images X′1, 2, 3, . . . j based on an acquired patient image X, where a patient target volume (PTV) is located at j different positions within a radiation-firing zone (RFZ) of a patient;
calculating a dose Dj for each of the images X′1, 2, 3, . . . j by multiplying a dose calculation matrix A with a radiation-firing matrix P and X′j (Dj=A·P·Xj′);
plotting a dose-volume histogram (DVH) curve for each dose Dj to generate a family of j DVH curves, wherein the DVH curve for each dose Dj represents a volume fraction for each dose value; and
generating a minimum boundary curve (min-DVH curve) and a maximum boundary curve (max-DVH curve) of the family of DVH curves, wherein the min-DVH curve comprises a first series of points that represent a minimum volume fraction for each dose value of the family of DVH curves, and the max-DVH curve comprises a second series of points that represent a maximum volume fraction for each dose value.

### Claim 2 (depends on 1)

The method of claim 1, wherein generating a plurality of images X′j comprises simulating j three-dimensional rigid shifts of the PTV within the RFZ for each of the images X′j.

### Claim 3 (depends on 1)

The method of claim 1, wherein generating a plurality of images X′j comprises changing intensity values of the PTV in each image X′j to simulate a range of standard uptake values (SUVs).

### Claim 4 (depends on 3)

The method of claim 3, wherein changing intensity values of the PTV comprises increasing the intensity values of the PTV to be +25% over a nominal intensity value.

### Claim 5 (depends on 3)

The method of claim 3, wherein changing intensity values of the PTV comprises decreasing the intensity values of the PTV to be −25% under a nominal intensity value.

### Claim 6 (depends on 1)

The method of claim 1, wherein the acquired image X is a PET image.

### Claim 7 (depends on 1)

The method of claim 1, wherein generating a min-DVH curve comprises fitting the first series of points to a first curve, and generating a max-DVH curve comprises fitting the second series of points to a second curve.

### Claim 8 (depends on 1)

The method of claim 1, wherein the dose calculation matrix A and the radiation-firing matrix P are derived based on the acquired patient image X prior to a treatment session.

### Claim 9 (depends on 1)

The method of claim 1, wherein the patient image X is a first patient image, and the method further comprises acquiring a second patient image Y, calculating a dose DY by multiplying the dose calculation matrix A with the radiation-firing matrix P and Y (DY=A·P·Y), and plotting a DVH curve corresponding to second patient image Y.

### Claim 10 (depends on 9)

The method of claim 9, further comprising generating a notification if the DVH curve of the second patient image Y is not bounded between the min-DVH curve and the max-DVH curve.

### Claim 11 (depends on 10)

The method of claim 10, wherein the notification is a visual notification and/or an audio notification.

### Claim 12 (depends on 10)

The method of claim 10, wherein the DVH curve corresponding to the second patient image Y represents a volume fraction over the PTV for each dose value.

### Claim 13 (depends on 10)

The method of claim 10, wherein the DVH curve corresponding to the second patient image Y represents a volume fraction over an organ-at-risk (OAR) for each dose value.

### Claim 14 (depends on 9)

The method of claim 9, wherein plotting a DVH curve for each dose Dj comprises plotting a volume fraction over the PTV for each dose value to generate a family of j DVH curves for the PTV.

### Claim 15 (depends on 14)

The method of claim 14, further comprising plotting a DVH curve for each dose Dj by plotting a volume fraction over an organ-at-risk (OAR) for each dose value to generate a family of j DVH curves for the OAR, and wherein the min-DVH curve is an OAR min-DVH curve and the max-DVH curve is an OAR max-DVH curve.

### Claim 16 (depends on 15)

The method of claim 15, wherein the DVH curve corresponding to the second image Y is an OAR DVH curve, and wherein the method further comprises generating a notification if the DVH curve of the OAR in the second patient image Y exceeds the max-DVH curve of the OAR.

### Claim 17 (depends on 1)

The method of claim 1, further comprising displaying the min-DVH curve and the max-DVH curve on a display.

### Claim 18 (depends on 17)

The method of claim 17, wherein the display is a display of a radiation therapy system.

### Claim 19

A method for evaluating a radiotherapy treatment plan, the method comprising:
acquiring imaging data x of a patient;
calculating a radiation dose Dx and plotting a dose-volume histogram (DVH) based on the acquired imaging data, a radiation-firing matrix P, and a dose calculation matrix A (Dx=A·P·x); and
generating a notification that is displayed on a monitor if the DVH is not within a range defined by a minimum-DVH curve and a maximum-DVH curve.

### Claim 20 (depends on 19)

The method of claim 19, further comprising generating a notification that is displayed on the monitor if the radiation dose distribution Dx is not within a dose distribution range defined by a minimum dose threshold and a maximum dose threshold.

### Claim 21 (depends on 19)

The method of claim 19, wherein the imaging data is PET imaging data.

### Claim 22 (depends on 19)

The method of claim 19, further comprising calculating a plan-quality index (PQI) based on the acquired imaging data x, and generating a notification that is displayed on a monitor if the PQI is not within a PQI range defined by a minimum PQI threshold and a maximum PQI threshold.