WO2025072126A1 - Systèmes et procédés de traitement du cancer du pancréas - Google Patents
Systèmes et procédés de traitement du cancer du pancréas Download PDFInfo
- Publication number
- WO2025072126A1 WO2025072126A1 PCT/US2024/048097 US2024048097W WO2025072126A1 WO 2025072126 A1 WO2025072126 A1 WO 2025072126A1 US 2024048097 W US2024048097 W US 2024048097W WO 2025072126 A1 WO2025072126 A1 WO 2025072126A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- electrodes
- pancreatic cancer
- medical device
- stimulation lead
- electrical stimulation
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36002—Cancer treatment, e.g. tumour
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/0507—Electrodes for the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36007—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation of urogenital or gastrointestinal organs, e.g. for incontinence control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/18—Applying electric currents by contact electrodes
- A61N1/32—Applying electric currents by contact electrodes alternating or intermittent currents
- A61N1/36—Applying electric currents by contact electrodes alternating or intermittent currents for stimulation
- A61N1/36014—External stimulators, e.g. with patch electrodes
- A61N1/36017—External stimulators, e.g. with patch electrodes with leads or electrodes penetrating the skin
Definitions
- Embodiments herein relate to implantable systems for cancer treatment and related methods. More specifically, embodiments herein relate to implantable systems and methods for treatment of pancreatic cancer.
- Cancerous tumors can form if one normal cell in any part of the body mutates and then begins to grow and multiply too much and too quickly. Cancerous tumors can be a result of a genetic mutation to the cellular DNA or RNA that arises during cell division, an external stimulus such as ionizing or non-ionizing radiation, exposure to a carcinogen, or a result of a hereditary gene mutation. Regardless of the etiology, many cancerous tumors are the result of unchecked rapid cellular division.
- Pancreatic cancer is a type of cancer that originates in the pancreas, an organ that produces digestive enzymes and hormones such as insulin. Pancreatic cancer can be difficult to detect and treat because it often does not cause symptoms until it has spread limiting treatment options. For example, ingrowth into the superior mesenteric artery or celiac axis can cause the tumor to be unresectable, substantially limiting treatment options. Summary
- Embodiments herein relate to implantable systems and methods for treatment of pancreatic cancer.
- a method of treating pancreatic cancer including inserting an electrical stimulation lead through the inferior vena cava, a hepatic vein, and into the portal vein via a transjugular intrahepatic portosystem shunt (TIPS).
- TIPS transjugular intrahepatic portosystem shunt
- the method can further include inserting the electrical stimulation lead into at least one of the superior mesenteric vein and the splenic vein.
- the method can further include positioning electrodes connected to the lead within at least one of the superior mesenteric vein and the splenic vein and delivering one or more electric fields through the electrodes to a treatment zone including at least a portion of the pancreas.
- the electric fields can be at frequencies and a field strength effective to prevent and/or disrupt cellular mitosis in a cell.
- inserting the electrical stimulation lead can include inserting a first electrical stimulation lead into the superior mesenteric vein and inserting a second electrical stimulation lead into the splenic vein.
- the one or more electric fields can be at a field strength of 1 V/cm to 10 V/cm within a treatment zone.
- the method can further include selecting a patient with an unresectable pancreatic tumor.
- At least one the electrodes can have an axial length from 1.5 to 2.5 centimeters.
- At least one the electrodes can have a diameter of 0.8 to 1.2 millimeters.
- the method can further include selecting one or more pairs of electrodes forming a vector across which to deliver electrical fields.
- a method of treating pancreatic cancer can be included .
- the method can include inserting an electrical stimulation lead into the inferior vena cava.
- the method can further include positioning electrodes on the lead within the inferior vena cava and adjacent to the pancreas.
- the method can further include delivering one or more electric fields through the electrodes to a treatment zone including at least a portion of the pancreas.
- the one or more electric fields can be at frequencies and field strengths effective to prevent and/or disrupt cellular mitosis in a cell.
- the medical device in addition to one or more of the preceding or following aspects, or in the alternative to some aspects, can further include implanting a medical device configured to generate the one or more electrical fields, the medical device can include control circuitry and a therapy output circuit. The method can further include attaching the electrical stimulation lead to the medical device.
- the medical device can further include a conductive housing, wherein the conductive housing can be configured to serve as an electrode for use with delivering the one or more electrical fields.
- the one or more electric fields can be at a field strength of 1 V/cm to 10 V/cm within the treatment zone.
- the method can further include selecting a patient with an unresectable pancreatic tumor.
- At least one the electrodes can have an axial length from 1.5 to 2.5 centimeters.
- At least one the electrodes can have a diameter of 0.8 to 1.2 millimeters.
- the method can further include selecting one or more pairs of electrodes forming a vector across which to deliver electrical fields.
- a method of treating pancreatic cancer can be included.
- the method can include inserting electrical stimulation electrodes into a patient, positioning the electrodes into a ductal system of a pancreas of the patient, and delivering one or more electric fields through the electrodes to a treatment zone including at least a portion of the pancreas.
- the one or more electric fields can be at frequencies selected from a range of between 10 kHz to 1 MHz, wherein the electric fields can be effective to prevent and/or disrupt cellular mitosis in a cell.
- the method can further include positioning the electrodes in the main pancreatic duct of the pancreas of the patient.
- the method can further include inserting the electrodes through at least one of the minor duodenal papilla and the major duodenal papilla of the patient.
- the method can further include implanting a medical device configured to generate the one or more electrical fields and attaching the electrodes to the medical device.
- the medical device can include control circuitry and a therapy output circuit.
- the medical device further can include a conductive housing, wherein the conductive housing can be configured to serve as an electrode for use with delivering the one or more electrical fields.
- the method can further include selecting one or more pairs of electrodes forming a vector across which to deliver electrical fields.
- FIG. 10 is a schematic cross-sectional view of a medical device in accordance with various embodiments herein.
- Pancreatic cancer can be difficult to detect and treat because it often does not cause symptoms until it has spread, thereby limiting treatment options. For example, ingrowth into the superior mesenteric artery or celiac axis can cause the tumor to be deemed unresectable, substantially limiting treatment options.
- the method can further include positioning electrodes on the lead into at least one of the superior mesenteric vein and the splenic vein and delivering one or more electric fields through the electrodes to a treatment zone including at least a portion of the pancreas.
- the electric fields can be at frequencies and field strengths that are effective to prevent and/or disrupt cellular mitosis in a cell, but less than that used for tissue ablation. Further details regarding the electric fields are provided below.
- FIG. 1 a simplified schematic view of the pancreas 102 is shown in accordance with various embodiments herein. Along with the pancreas 102, the superior mesenteric vein 108 is shown. In this view, the duodenum 104 of a patient is also shown along with a portal vein 106.
- the pancreas 102 can be divided into various portions. For example, the pancreas 102 includes the tail 110, body 112, neck 114, head 116, and uncinate process 118.
- FIG. 2 a simplified schematic view of a portion of anatomy including the pancreas 102 is shown in accordance with various embodiments herein.
- the superior mesenteric vein 108, duodenum 104, and portal vein 106 are shown along with the pancreas 102.
- Additional anatomical features shown in this view include an inferior mesenteric vein 208, splenic vein 210, and liver 202.
- the liver 202 is shown along with portions of the hepatic veinous system 204 and portions of the hepatic portal system 206.
- Various of these anatomical features can be utilized in order to insert an electrical stimulation lead into a position so as to allow for treatment of a targeted zone that can be within or include at least a portion of the pancreas 102.
- FIG. 3 a schematic view of an exemplary lead insertion pathway 302 is shown in accordance with various embodiments herein.
- the pancreas 102 is shown along with the superior mesenteric vein 108, duodenum 104, portal vein 106, inferior mesenteric vein 208, splenic vein 210, and liver 202.
- the liver 202 is shown along with portions of the hepatic veinous system 204 and portions of the hepatic portal system 206.
- the lead insertion pathway 302 can include the inferior vena cava 304, the hepatic veinous system 204, a transjugular intrahepatic portosystem shunt (TIPS) 306, the hepatic portal system 206, portal vein 106, and then into splenic vein 210 and/or superior mesenteric vein 108.
- the inferior vena cava 304 can be surgically accessed in various ways including, but not limited to, jugular access and femoral access.
- a stent -graft can be placed as part of forming the transjugular intrahepatic portosystem shunt 306.
- a first electrical stimulation lead can be inserted into the superior mesenteric vein 108 and a second electrical stimulation lead can be inserted into the splenic vein 210.
- FIG. 4 a schematic view of electrical stimulation leads and electrodes is shown in accordance with various embodiments herein.
- the pancreas 102 is shown along with a splenic vein 210 and a portal vein 106.
- FIG. 4 shows an implantable medical device 402. Attached to the implantable medical device 402, FIG. 4 also shows a first electrical stimulation lead 404 including a first electrode 408 and a second electrode 410 (though it will be appreciated that various numbers of electrodes can be used on an electrical stimulation lead such as 1, 2, 3, 4, 4, 6, etc.).
- FIG. 4 shows an implantable medical device 402. Attached to the implantable medical device 402, FIG. 4 also shows a first electrical stimulation lead 404 including a first electrode 408 and a second electrode 410 (though it will be appreciated that various numbers of electrodes can be used on an electrical stimulation lead such as
- a second electrical stimulation lead 406 which includes a third electrode 412 and a fourth electrode 414 disposed thereon. Pairs of electrodes can be used to form vectors across which electrical fields are delivered to a treatment site including at least a portion of the pancreas 102.
- at least one electrode can be positioned at least slightly above a mid-point of a target therapy zone (such as a position of a tumor to be treated).
- at least one electrode can be positioned at least slightly below a mid-point of a target therapy zone (such as a position of a tumor to be treated).
- at least one electrode can be positioned so that it is substantially centered within the target therapy zone (such as a position of a tumor to be treated).
- the implantable medical device 402 further can include a conductive housing, wherein the conductive housing can be configured to serve as an electrode for use with delivering the one or more electrical fields. Further details of exemplary implantable medical devices are provided in greater detail below.
- FIG. 5 shows a patient 502 along with an implantable medical device 402.
- the pancreas 102 of the patient 502 is schematically shown along with the duodenum 104 and the inferior vena cava 304.
- the electrical stimulation lead 506 includes a first electrode 508, a second electrode 510, and a third electrode 512. Pairs of electrodes can be used to form vectors across which electrical fields are delivered to a treatment site including at least a portion of the pancreas 102.
- At least one electrode can be positioned at least slightly above a midpoint of a target therapy zone (such as a position of a tumor to be treated).
- at least one electrode (such as third electrode 512) can be positioned at least slightly below a mid-point of a target therapy zone (such as a position of a tumor to be treated).
- at least one electrode (such as second electrode 510) can be positioned so that it is substantially centered vertically within the target therapy zone.
- a second electrical stimulation lead can be implanted transversely across the abdomen, such as subcutaneously outside of the anterior abdominal muscles, inside of the abdominal cavity, etc.
- FIG. 5 shows a second implantable device 520 along with a transverse abdominal electrical stimulation lead 522.
- the transverse abdominal electrical stimulation lead 522 also includes a first abdominal electrode 524 and a second abdominal electrode 526. Pairs of electrodes (on one or both leads) can be used to form vectors across which electrical fields are delivered to a treatment site including at least a portion of the pancreas 102.
- At least one electrode is disposed to one lateral side of a target therapy zone (such as a position of a tumor to be treated) and at least one electrode is disposed to the other lateral side of the target therapy zone.
- a single implantable device can be used, such that in this example both electrical stimulation leads can be connected to the same implantable medical device (e.g., one of medical device 402 and second implantable device 520 can be omitted with both leads connected to the remaining device). As such, placement of medical device 402 and second implantable device 520 can be thought of as alternatives in some embodiments.
- only a single electrical stimulation lead (506 or 522) can be used as connected to one of the implantable devices (402 or 520).
- the ductal system of the pancreas can be used for the positioning of electrical stimulation leads herein.
- FIG. 6 a schematic view of electrical stimulation lead placement in accordance with various embodiments herein.
- the pancreas 102 is shown along with duodenum 104.
- the pancreas 102 is shown along with main pancreatic duct 602 and accessory pancreatic duct 604.
- the duodenum 104 is shown along with minor duodenal papilla 608 and major duodenal papilla 610.
- a lead 506 that is connected to medical device 402.
- the lead 506 passes through the interior of the duodenum 104 and into major duodenal papilla 610. Access to the major duodenal papilla 610 can be achieved using techniques similar to that used with ERCP (endoscopic retrograde cholangiopancreatography).
- the lead 506 then passes through main pancreatic duct 602.
- First electrode 508 and second electrode 510 on lead 506 are positioned within main pancreatic duct 602 in order to treat a site (such as a tumor) within or adjacent to pancreas 102.
- a site such as a tumor
- the leads and/or electrodes thereof can be disposed within any portion of the ductal system of the pancreas.
- the minor duodenal papilla 608 can be used instead or in addition to the major duodenal papilla 610 (in some embodiments, one lead can be inserted into minor duodenal papilla 608 and a second lead can be inserted into major duodenal papilla 610).
- the electrode and/or a portion of the lead can take the form of a stent or other expanding structure to allow the duct to remain open while also allowing the electrode to remain in position for treatment. Electrodes of other embodiments herein can also take the form of a stent or stent like structure. Also, it will be appreciated that leads herein (such as lead 506 in the context of FIG.
- the lead 506 can be as simple as one or more conductors (such as one or more insulated wires) in some embodiments, but in other embodiments can include a more complex structure such as that depicted with regard to FIG. 8 herein.
- electrical stimulation leads herein can be directed placed/inserted into a desired site and avoiding critical structures and/or ducts and veins.
- a plunge lead/electrode(s) can be used to place the electrodes of a lead at a desired site to treat a site (such as a tumor) within or adjacent to pancreas 102.
- FIG. 7 a schematic view of electrical stimulation lead placement in accordance with various embodiments herein.
- lead 506 is connected to medical device 402. The lead 506 passes to a desired treatment site such that first electrode 508 and second electrode 510 on lead 506 are positioned properly to treat a site (such as a tumor) within or adjacent to pancreas 102.
- the electrodes can take the form of plunge electrodes and can be inserted such as using a catheter and/or insertion needle, such as with a lead over approach.
- the leads can be tunneled in from various points, such as being tunneled in from the abdomen.
- multiple leads can be used.
- multiple leads can be used to surround and/or triangulate around a desired treatment site, such as a tumor.
- the cancer therapy stimulation lead 506 can include a lead body 802 with a proximal end 804 and a distal end 806.
- a first electrode 808 and a second electrode 809 are coupled to the lead body 802, as positioned near a distal end 806 thereof.
- the electrodes 808, 809 can include electric field generating electrodes (which can function as working electrodes or counter electrodes depending on the system configuration).
- the electrodes 808, 809 can include electric field sensing electrodes.
- the electrodes 808, 809 can be internally connected or internally independent.
- the lead body 802 can define a lumen.
- the electrodes 808, 809 can include various conductive materials such as platinum, silver, gold, iridium, titanium, and various alloys.
- the cancer therapy stimulation lead 506 includes more than two electrodes.
- the electrodes can be of various sizes.
- at least one of the electrodes has a diameter of 0.8 to 1.2 millimeters.
- at least one the electrodes has an axial length from 1.5 to 2.5 centimeters.
- the cancer therapy stimulation lead 506 can include one or more therapy zone temperature sensors disposed along a length of the cancer therapy stimulation lead.
- a therapy zone temperature sensor 811 is positioned between the first electrode 808 and the second electrode 809.
- the therapy zone temperature sensor 811 can also be positioned at various other points along or in the lead.
- the therapy zone temperature sensor 811 can be positioned in the lead directly beneath an electrode.
- the therapy zone temperature sensor 811 can include an optical or electrical thermal sensor.
- the therapy zone temperature sensor can include a thermistor.
- the therapy zone temperature sensor 811 can be used to measure the thermal heating about the cancer therapy stimulation lead to provide feedback to a clinician about the local thermal heating zone around the lead and provide a tissue temperature of the treatment site to the medical device.
- the therapy zone temperature sensor 811 can provide a tissue temperature at a site offset from a surface of the electrodes 808, 809. If a tissue temperature of a site offset from the electrodes 808, 809 is measured, the medical device can compensate for the offset when measuring or estimating the temperature of the tissue. In some embodiments, the therapy zone temperature sensor 811 can measure or estimate the reference or core body temperature of the patient when the therapy is turned off or paused. While not intending to be bound by theory, in some scenarios it can be easier to get an accurate measurement of a reference or core body temperature when therapy is turned off or paused. In some embodiments, therapy zone temperature sensor data can be recorded and relayed to the clinician, patient, care provider, and/or medical record system.
- the cancer therapy stimulation lead 506 can further include a terminal pin 810 for connecting the cancer therapy stimulation lead 506 to a medical device, such as a cancer treatment device.
- the terminal pin 810 can be compatible with various standards for lead-header interface design including the DF-1, VS-1, IS-1, LV-1 and IS-4 standards, amongst other standards.
- the cancer therapy stimulation lead 506 can further include a fixation element 812, such as an element that can adhere to a portion of the subject’s body to maintain the position of the cancer therapy stimulation lead 506 and/or the electrodes 808.
- the fixation element 812 can be disposed along the distal end 806 of the cancer therapy stimulation lead 506. However, in some embodiments a fixation element 812 is omitted.
- each of the electrodes 808 can have individual first conductors 904 and second conductors 906 to electrically couple the electrode 808 to the proximal end 804 of the cancer therapy stimulation lead 506. However, in some embodiments, each of the electrodes 808 only connects to a single conductor to electrically couple the electrode 808 to the proximal end 804 of the cancer therapy stimulation lead 506.
- the first conductor 904 and a second conductor 906 can be configured as a coil or a cable. Multiple conductors can be disposed within the lumen of the outer layer 900. For example, a separate conductor or set of conductors can be in communication with each electrode disposed along the lead.
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
Des modes de réalisation de la présente invention concernent des systèmes implantables et des méthodes de traitement du cancer du pancréas. Dans un mode de réalisation, un procédé de traitement du cancer du pancréas est inclus, le procédé comprenant l'insertion d'un fil de stimulation électrique à travers la veine cave inférieure, une veine hépatique, et dans la veine porte par l'intermédiaire d'un shunt portosystémique intrahépatique transjugulaire (TIPS). Le procédé peut en outre comprendre l'insertion du fil de stimulation électrique dans la veine mésentérique supérieure et/ou la veine splénique. Le procédé peut en outre comprendre le positionnement d'électrodes sur le fil à l'intérieur de la veine mésentérique supérieure et/ou de la veine splénique et la délivrance d'un ou plusieurs champs électriques à travers les électrodes vers une zone de traitement comprenant au moins une partie du pancréas. Les champs électriques peuvent être à des fréquences et une intensité de champ efficace pour prévenir et/ou perturber la mitose cellulaire dans une cellule.
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US202363540146P | 2023-09-25 | 2023-09-25 | |
| US63/540,146 | 2023-09-25 | ||
| US18/893,371 US20250099751A1 (en) | 2023-09-25 | 2024-09-23 | Pancreatic cancer treatment systems and methods |
| US18/893,371 | 2024-09-23 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2025072126A1 true WO2025072126A1 (fr) | 2025-04-03 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/US2024/048097 Pending WO2025072126A1 (fr) | 2023-09-25 | 2024-09-24 | Systèmes et procédés de traitement du cancer du pancréas |
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| Country | Link |
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| WO (1) | WO2025072126A1 (fr) |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7809441B2 (en) | 2006-05-17 | 2010-10-05 | Cardiac Pacemakers, Inc. | Implantable medical device with chemical sensor and related methods |
| US20190046792A1 (en) * | 2008-10-09 | 2019-02-14 | Virender K. Sharma | Methods and Apparatuses for Stimulating Blood Vessels in Order to Control, Treat, and/or Prevent a Hemorrhage |
| US20190117970A1 (en) * | 2017-10-23 | 2019-04-25 | Cardiac Pacemakers, Inc. | Electric field shaping leads for treatment of cancer |
| US20200330756A1 (en) * | 2019-04-22 | 2020-10-22 | Boston Scientific Scimed, Inc. | Electrical stimulation devices for cancer treatment |
| US20210299440A1 (en) * | 2020-03-30 | 2021-09-30 | Novocure Gmbh | Intravenous / Intra-Spinal / Intra-Cavity / Intraventricular Delivery of TTFields (Tumor Treating Fields) for Treating Cancer and Metastases |
-
2024
- 2024-09-24 WO PCT/US2024/048097 patent/WO2025072126A1/fr active Pending
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7809441B2 (en) | 2006-05-17 | 2010-10-05 | Cardiac Pacemakers, Inc. | Implantable medical device with chemical sensor and related methods |
| US20190046792A1 (en) * | 2008-10-09 | 2019-02-14 | Virender K. Sharma | Methods and Apparatuses for Stimulating Blood Vessels in Order to Control, Treat, and/or Prevent a Hemorrhage |
| US20190117970A1 (en) * | 2017-10-23 | 2019-04-25 | Cardiac Pacemakers, Inc. | Electric field shaping leads for treatment of cancer |
| US20200330756A1 (en) * | 2019-04-22 | 2020-10-22 | Boston Scientific Scimed, Inc. | Electrical stimulation devices for cancer treatment |
| US20210299440A1 (en) * | 2020-03-30 | 2021-09-30 | Novocure Gmbh | Intravenous / Intra-Spinal / Intra-Cavity / Intraventricular Delivery of TTFields (Tumor Treating Fields) for Treating Cancer and Metastases |
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