QUANTIFICATION OF IMMUNOLOGICAL STATUS AND TREATMENT PLANNING
Methods, devices and systems are provided to analyze the immunologic response of patients at various times before, during and/or after immunomodulating therapy, particularly treatment with specialized pulsed electric field energy. In some embodiments, such methods, devices and systems include a laboratory developed test that utilizes a patient tumor biopsy sample and a series of blood draws to determine whether the locoregional therapy (with or without additional systemic therapies, or systemic therapies-alone) was sufficient to facilitate an increase in tumor-specific antibody production. In some embodiments, the focus is on evaluation of baseline antibody levels, prior to any treatment, and changes in levels of antibodies to given antigens, especially in response to a given therapy treatment. In such embodiments, this antibody testing is performed prior to treatment. The treatment, such as delivery of specialized PEF energy to a target tissue, is then performed and antibody levels are checked at one or more later timepoints to detect changes in the presence of antibodies and therefore response to therapy.
1 . A method of treatment planning for a patient, the method comprising:
delivering pulsed electric field energy to the patient;
generating an evaluation of antibody production by the patient in response to the delivering of pulsed electric field energy; and
utilizing the evaluation to plan future treatment of the patient.
2 . The method of claim 1 , wherein the evaluation comprises a quantification of the antibody production.
3 . The method of claim 1 , wherein the evaluation comprises identification of one or more types of antibodies in the antibody production.
4 . The method of claim 1 , wherein the pulsed electric field energy comprises packets of biphasic pulses.
5 . The method of claim 1 , wherein generating an evaluation of antibody production comprises:
obtaining a biospecimen from the patient after providing the treatment to the patient, wherein the biospecimen has antibodies;
combining at least a portion of the biospecimen with at least one target antigen; and
generating a colorimetric solution having an optical density that indicates an amount of antibodies present in the at least a portion of the biospecimen that have bound to the at least one target antigen thereby indicating antibody production.
6 . The method of claim 5 , wherein generating a colorimetric solution comprises combining tagging antibodies with the amount of antibodies.
7 . The method of claim 6 , wherein the tagging antibodies are specific to an antibody type IgA, IgM, IgG, or IgE.
8 . The method of claim 6 , wherein generating the colorimetric solution comprises conjugating the tagging antibodies with an identifying material.
9 . The method of claim 8 , wherein the identifying material comprises an enzyme.
10 . The method of claim 8 , wherein generating the colorimetric solution comprises combining a color revealing solution with the conjugated tagging antibodies so as to induce a colorimetric chemical reaction that colors or changes color of the color revealing solution.
11 . The method of claim 10 , wherein a degree of optical density directly correlates to quantity of tagging antibody.
12 . The method of claim 10 , further comprising measuring the optical density.
13 . The method of claim 5 , wherein a higher optical density correlates to a higher amount of antibodies present.
14 . The method of claim 5 , wherein the at least one target antigen is obtained from the patient.
15 . The method of claim 14 , wherein the at least one target antigen is obtained from a tumor and the at least one target antigen is a tumor antigen.
16 . The method of claim 5 , wherein the at least one target antigen is synthetically produced.
17 . The method of claim 5 , wherein the biospecimen comprises blood.
18 . The method of claim 1 , wherein the future treatment comprises additional delivery of pulsed electric field energy.
19 . A method of determining an immunological status of a patient, the method comprising:
obtaining a biospecimen having antibodies from the patient;
combining at least a portion of the biospecimen with at least one target antigen;
generating a colorimetric solution having an optical density that indicates an amount of the antibodies present in the at least a portion of the biospecimen that have bound to the at least one target antigen; and
determining the immunological status of the patient based at least in part on the amount.
20 . The method of clause 19 , wherein generating a colorimetric solution comprises combining tagging antibodies with the amount of antibodies, conjugating the tagging antibodies with an identifying material, and combining a color revealing solution with the conjugated tagging antibodies so as to induce a colorimetric chemical reaction that colors or changes color of the color revealing solution.