Treatment planning for immunotherapy based treatments using non-thermal ablation techniques
Inventors
Davalos, Rafael V. • WHITE, NATALIE BEITEL • DERVISIS, NIKOLAOS • ALLEN, IRVING COY
Assignees
Virginia Tech Intellectual Properties Inc • Virginia Polytechnic Institute and State University
Publication Number
US-11311329-B2
Publication Date
2022-04-26
Expiration Date
2039-03-13
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Abstract
Described herein are methods of performing immunotherapy on a subject and/or determining if a subject will be responsive to ablation immunotherapy.
Core Innovation
The invention provides methods of performing immunotherapy on a subject and/or determining if a subject will be responsive to ablation immunotherapy, particularly in the context of treating cancer. The disclosed method involves ablating tissue using a non-thermal ablation technique, such as irreversible electroporation (IRE) or high-frequency irreversible electroporation (H-FIRE), followed by real-time measurement of a treatment parameter during the ablation procedure. This treatment parameter is typically bulk tissue conductivity, which can be measured by assessing the current delivered during the ablation step.
In response to the measured change in the treatment parameter, an additional treatment is administered to the subject. The nature and timing of this additional treatment are determined based on pre-defined thresholds of the treatment parameter. For example, if the measured current is between 25 A and 100 A, the additional treatment may be delayed by 4–30 days post-ablation to allow for optimal immune response activation. The additional treatment may consist of tissue resection, thermal or non-thermal ablation, chemotherapy, radiation therapy, immunotherapy, biologic or genetic therapy, or measurement of specific immune molecules or cells in the subject.
The problem addressed by this invention is the lack of effective treatment customization in cancer immunotherapy, particularly for cancers with poor prognosis such as metastatic or unresectable tumors. Traditional treatments, including thermal ablation, resection, and chemotherapy, can suppress the patient's immune system, reducing the efficacy of immunotherapies. The invention enables real-time adjustment of treatment plans to support, maintain, and enhance the natural immune response, improving patient-specific outcomes and enabling clinicians to make data-driven decisions during and after non-thermal ablation procedures.
Claims Coverage
The patent includes three independent claims that define inventive methods for cancer treatment using non-thermal ablation with real-time parameter monitoring and responsive therapy.
Non-thermal ablation with real-time measurement and immunological monitoring as additional treatment
A method of treating tissue in a subject comprising: - Ablating the tissue using a non-thermal ablation technique. - Measuring a change in a treatment parameter (such as bulk tissue conductivity or current) during ablation. - Administering an additional treatment to the subject in response to the measured change, wherein the additional treatment includes measuring the amount of a pro-inflammatory immune molecule or cell, a suppressive immune molecule or cell, or both, in a bodily fluid or a biopsied tissue.
Non-thermal ablation with current-based timing for additional treatment
A method of treating a tissue in a subject comprising: - Ablating tissue using a non-thermal ablation technique. - Measuring a change in a treatment parameter during ablation (specifically by measuring current). - Administering an additional treatment in response to the measured change, where: - The additional treatment occurs 4 to 30 days after ablating when the current measured is between 25 A and 100 A.
Plurality of electrical pulses with current-responsive timing for additional treatment
A method of treating tissue in a subject comprising: - Applying a plurality of electrical pulses to tissue, configured to cause non-thermal ablation. - Measuring the current of the applied pulses. - Administering an additional treatment based on the measured current, such that: - The additional treatment occurs 0–5 days after ablation when the current is less than 25 A. - The additional treatment occurs 4–30 days after ablation when the current is between 25 A and 100 A.
The inventive features cover methods that combine non-thermal ablation of tissue (such as using irreversible electroporation), real-time monitoring of a treatment parameter (such as current or tissue conductivity), and the timing or selection of additional treatments—including specific immunological assays—based on these monitored parameters.
Stated Advantages
Enables treatment customization and optimization at the individual patient level based on real-time feedback during non-thermal ablation.
Supports, maintains, and enhances the natural biological immune response by appropriately timing additional therapies after non-thermal ablation.
Facilitates precise patient stratification and enables clinicians to prescribe customized and precise care, thereby improving overall treatment outcomes.
Allows for identification of patients likely to respond to immunotherapy, potentially preventing unnecessary or ineffective treatment rounds.
Improves activation and promotion of both innate and adaptive immune responses, which can enhance detection and eradication of primary and metastatic cancer cells.
Documented Applications
Treatment of unresectable or metastatic cancers using non-thermal ablation combined with immunotherapy planning and monitoring.
Creating and adjusting cancer treatment regimens for individual patients based on real-time measurement of tissue response during non-thermal ablation.
Screening patients to determine likelihood of immunotherapy response post-non-thermal ablation.
Delaying or selecting secondary treatments such as tissue resection, chemotherapy, or additional ablation based on measured parameters from initial non-thermal ablation.
Improving the detection and treatment of primary tumors and metastatic lesions in contexts such as pancreatic ductal adenocarcinoma and hepatocellular carcinoma.
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