Cyst fluid viscosity as a marker for malignancy

Patent metadata

Field	Value
Publication number	US-11740225-B2
Application number	US-201815972671-A
Country	US
Kind code	B2
Filing date	May 7, 2018
Priority date	May 7, 2017
Publication date	Aug 29, 2023
Grant date	Aug 29, 2023

Abstract

The present invention provides methods for determining malignancy in a cyst by measuring viscosity of cyst fluid while under stain. The invention further provides devices, and computer program products for determining same.

First claim

The invention claimed is:

1. A method for determining malignancy or malignant potential of a cyst, comprising,
a. providing fluid from said cyst, and
b. measuring viscosity of said fluid under a strain rate of at least 1000 seconds −1 ,
wherein a viscosity of at least 1.3 centipoise (cP) characterizes said cyst as malignant or potentially malignant, thereby determining malignancy or malignant potential in a cyst.

2. The method of claim 1 , wherein said strain rate is at least 2000 seconds 1 .

3. The method of claim 1 , wherein said cyst is within a subject and said providing comprises fine needle aspiration.

4. The method of claim 3 , wherein said fine needle aspiration is endoscopic ultrasound-guided fine needle aspiration.

5. The method of claim 3 , wherein said subject is a human.

6. The method of claim 1 , wherein said cyst is a pancreatic cyst.

7. The method of claim 1 , further comprising analyzing at least one other factor in combination with cyst fluid viscosity, wherein said at least one other factor is selected from:
a. age of a subject comprising said cyst;
b. amylase levels in said cyst fluid; and
c. carcinoembryonic antigen (CEA) levels in said cyst fluid.

8. The method of claim 7 , comprising analyzing cyst fluid viscosity in combination with age of a subject comprising said cyst.

9. The method of claim 1 , wherein said measuring viscosity is performed using a rotational viscometer.

10. The method of claim 9 , wherein said rotational viscometer uses cone-plate geometry.

11. The method of claim 1 , wherein said determining malignancy or malignant potential comprises determining if said cyst is a mucinous cyst (MC) or a non-mucinous cyst (NMC).

12. The method of claim 1 , wherein said determining comprises at least 80% accuracy.

13. The method of claim 1 , wherein said determining comprises greater accuracy than determining by all of:
a. string-sign test;
b. measuring amylase in said fluid; and
c. measuring CEA in said fluid.

14. The method of claim 1 , wherein said cyst is in a subject and further comprising removing said cyst from said subject if said viscosity is at least 1.3 centipoise (cP).

15. A device for determining malignancy in a cyst, comprising,
a. a chamber,
b. a control unit, and
c. a display,
wherein said control unit is configured to apply a predetermined strain rate of at least 1000 seconds −l to fluid in said chamber and to measure said fluid's viscosity under said strain, and wherein said display provides a characterization of malignancy of said cyst.

16. The device of claim 15 , wherein the strain rate is at least 2000 seconds 1 .

17. The device of claim 15 , wherein characterization of malignancy of said cyst comprises comparing said viscosity under strain to a threshold viscosity of 1.3 cP and wherein a viscosity under strain of at least said threshold indicates said cyst is malignant.

18. A computer program product comprising a non-transitory computer-readable storage medium having program code embodied thereon, the program code executable by at least one hardware processor to:
(a) measure viscosity of a fluid under a strain rate of at least 1000 seconds −1 ;
(b) compare said viscosity of said fluid to a threshold viscosity of 1.3 cP; and
(c) provide an output regarding the malignancy of a cyst that produced said fluid, wherein a viscosity of said fluid that is at least the threshold viscosity indicates said cyst that produced said fluid is malignant.

19. The computer program product of claim 18 , wherein the program code is further executable by at least one hardware processor to apply a strain rate of at least 1000 seconds −1 to said fluid.

Assignees

• Rambam Med Tech Ltd
• Technion Res & Dev Foundation

Inventors

• Khamaysi Iyad
• Zussman Eyal

Classifications

• G01N33/57525

  of the liver or pancreas · CPC title

• G01N33/487 Primary

  of liquid biological material · CPC title

• A61B10/04

  Endoscopic instruments, e.g. catheter-type instruments · CPC title

• A61B17/3403

  Needle locating or guiding means · CPC title

• G01N33/57438

  Physics · mapped topic