Medical Preparations on the Basis of Ga-68
Generating System for Synthesis of Labeling Compounds on the Basis of Ga-68 and Transdermal Applications for Diagnostics and Therapies at Oncological and Cardiovascular Diseases.
Tech Area / Field
- MED-DID/Diagnostics & Devices/Medicine
3 Approved without Funding
ITEF (ITEP), Russia, Moscow
- Science and Production Organisation “Textilprogress”, Russia, Moscow\nA.I. Burnazyan Federal Medical and Biophysical Center, Russia, Moscow
- International Cancer Research Concortium, Inc., USA, VA, Gainesville\nBio-Nucleonics, Inc., USA, FL, Miami
Project summaryFor today, three most propagated reasons causing mortalities, physical inabilities and deterioration of the standard of living are cardiovascular and oncology diseases (standing after failures, accidents and their consequences). Therefore the methods of early revealing of these illnesses, the opportunity of authentic estimation of efficiency of the applied treatment methods are actual and in many respects determine the successes of the national public health services. Unfortunately, very often the person suffers not from one disease but from a complex of diseases which accompany the basic pathology or arise during its treatment. In particular, the cardiovascular patients often suffer from such accompanying diseases as thrombophlebitis and diabetes mellitis and from hardly healing wounds (trophic ulcers) resulting from these illnesses. The oncology patients also suffer from trophic and radial ulcers which are caused by depression of immunity at chemotherapy, or being a consequence of radial therapy. All above demands a thought over and reasonable treatment planning of the patient with use of a combination of various methods and medical technologies supporting one another.
The basic attention in the yielded project is paid to the problems of diagnostics of oncology and cardiovascular diseases, and also to the methods of treatment of accompanying complications.
The application of PET-method for diagnostics in oncology and cardiology, for development of quality monitoring of the efficiency of conducted therapy is considered rather perspective, since by means of PET it is possible to obtain the objective data about metabolism disturbances of tissues and organs and the quantitative data about blood supply of tumors, about destruction of tissues (including the data on dynamics of these indexes in course of the treatment). On the basis of these data it is possible to verify various pathologies with a great degree of reliability, to observe operatively the results of treatment. For these researches in the PET-centers equipped with the special accelerator, such nuclides as O-15, C-11, N-13 and F-18 are widely used. At the same time, in many cases similar researches can be carried out with the use of generated nuclides Ga-68, Cu-62, Rb-82, etc. that does not require availability of a special accelerator for production of short-life radionuclides in a clinical institution and essentially facilitates the implementation of researches works and reduces their cost.
Among all generated PET-nuclides, gallium-68 due to the set of its properties is related to the most perspective radionuclides. Now in Russia the generator of 68Ge/68Ga is produced for technological needs, however its eluate is not permitted for medical application and does not satisfy to the criteria of quality presented to radionuclides of medical purpose. Besides, the specific activity of 68Ga obtained by these generators is insufficient for successful marking of biologically active bonds which constitute the basis of radiopharmaceuticals of new generation. In this connection, one of problems of the offered project is the development, manufacturing of a pre-production model and comprehensive testing of the generating system for synthesis of medicines on the basis of Ga-68 for PET-research works.
Discovery of the receptors capable to interact with the natural peptides in tumoral cells, and also development of chemistry and technology of synthetic peptides have stipulated occurrence of a new class of radiopharmaceuticals - labeled peptides. Having very specific features, such medicines allow to record the change of molecules arising at various pathological conditions at the cellular level.
Within the scope of the planned work the following is required:
- To develop the technology of purification and concentrating of gallium-68 from eluate of industrial generator on the basis of special purpose sorbents;
- To create conditioning block of gallium-68 solution providing reduction of radionuclide (first of all 68Ga) and chemical admixtures at simultaneous augmentation of its volumetric activity;
- To create a system of automated synthesis of medicines (first of all the peptides marked by Gа-68) on the basis of 68Ge-68Ga generator for PET-researches of oncology and cardiovascular diseases;
- Preparation of the necessary documentation for the assertion of allowing documents for "Solution of gallium-68 for medical applications".
Speaking about the treatment problem of hardly curable wounds, the opportunity to use for these purposes the peptides and polypeptides based on various α-amino acids attracts the attention. In fact, the synthesis of everything necessary for functioning of a living organism is performed from α-amino acids. It is known that at introduction of amino acids and peptides the effect of accelerated adhesion of various wounds occurs. It is supposed, that at adhesion of wounds they serve as a necessary material for biosynthesis of necessary protein directly in a wound, starting and stimulating the natural mechanisms of biosynthesis.
The second, not less important problem of the proposed project is the development of technology of reception of treatment agents for hardly curable wounds which can frequently accompany oncology and cardiovascular diseases, and which complicate the treatment process of the basic disease and seriously deteriorate the quality of life of the treated patients. The feature of the offered development work includes application of a composite material on the basis of the textile carrier is used, biopolymers and some peptides for these purposes. At fulfillment of this work it is necessary to develop the methods and techniques providing the required parameters of mass transportation of medicines to the lesion center, to develop the methods and techniques of control of distribution and concentration of the medicine (with use of marked bonds on the basis of generated positron emitting radionuclides) in the wound and healthy tissues of the patient with the purpose of creation and practical implementation of new materials promoting the angenesis.
The objective of the Project is a complex improvement of treatment methods of oncology and cardiovascular diseases, perfection of quality of treatment and the life of patients. The Project is based on the measures which presume simultaneously:
- To improve quality of diagnostics of diseases;
- To increase efficiency of treatment, receiving the information on efficiency of the applied agents and methods immediately in the course of treatment;
- To provide effective treatment of pathologies accompanying the basic diseases owing to Creation and application of new materials of prolonged action with medicinal preparations for treatment of wounds of various etiological and situational nature at oncology and cardiovascular diseases with the use of polymeric (including albuminous) carriers.
The development of techniques and technologies for PET-diagnostics has been successfully developed in the SSC RF “ITEP” for many years.
SSC RF “IBP” has been for more than 50 years engaged into solution of problems of reception and excretion of radionuclides, their introduction into the necessary chemical combination, studying of biokinetics of the obtained medicines, selection of the most perspective ones and realizations of clinical tests. The institution developed practically all radiopharmaceuticals produced in the USSR and being manufactured in Russia now.
The methods of directed and controllable long application of medical preparations to the injured surfaces, including at treatment of hardly curable wounds of different etiology and trophic ulcers, have been developed and are still studied by NPO “Textilprogress”.
The complex of the problems resolved within the scope of the proposed project includes the methods of efficiency improvement of the course of treatment and postradial therapy, allowing improvement of diagnostics, and essential improvement of the quality of treatment and life of a patient with complex cardiovascular and oncologic diseases.
The implementation of the project provides an alternative employment of the scientists and engineers involved into weapon works, in the peaceful and socially significant medical program on development and organization of commercial production of instrumentation and radiopharmaceuticals, their clinical application, allows usage of their high scientific and technical potential.
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