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High Activity Generator for Radiotherapy

#2650


Development of High Activity Stationary Medical Generator of W-188/Re-188 and Cold Kits to the Generator for Radiotherapy on the Basis of Re-188 Eluate

Tech Area / Field

  • MED-RAD/Radiomedicine/Medicine
  • CHE-RAD/Photo and Radiation Chemistry/Chemistry

Status
8 Project completed

Registration date
10.12.2002

Completion date
01.06.2007

Senior Project Manager
Novozhilov V V

Leading Institute
FEI (IPPE), Russia, Kaluga reg., Obninsk

Supporting institutes

  • Medical Radiological Scientific Center, Russia, Kaluga reg., Obninsk

Collaborators

  • Bio-Nucleonics, Inc., USA, FL, Miami

Project summary

The goal of the proposed science-intensive inter-departmental project is performance of complex research aimed at application of technical and medical & biological capabilities of SSC RF IPPE and MRRC RAMS to develop fundamentals of the whole production cycle – from development of high activity stationary medical generator of W-188/Re-188 (up to 5 Ci) to production of radiopharmaceuticals and cold kits based on Re-188 eluate under clinical conditions just prior to a pharmaceutical injection to a patient for treatment of oncologic and non-oncologic diseases.

In spite of wide application of various beta-emitting radionuclides for treatment of oncologic diseases Re-188 is one of the most perspective radionuclides having a number of advantages over other radionuclides traditionally used for radiotherapy.

1. Unique nuclear and physical characteristics of Re-188 belong to its main advantages: short half-life period (17 hours) makes it more safe for patients, personnel, and the environment; the presence of b-emission of medium energy results in formation of optimum therapeutic dose to treat the pathologic foci (tumors and others); the presence of g-component with the energy of 155 keV (close to the emission energy of 99mTc) in the emission spectrum enables an effective monitoring of the labeled pharmaceutical’s behavior in patients body using gamma-camera.

2. The apparent advantage of Re-188 is the fact that it is a generator-produced radionuclide. The half-life period of the parent isotope W-188 is 69.4 days, it enables to use one generator during, approximately, 6 months.

3. A possibility of improving the generator’s economic parameters at the expense of increase of the generator activity and development of a stationary generator of activity of up to 5 Ci can also be considered among the generator advantages. This kind of generator is intended for operation in large centers with big number of patients. The stationary generators installed in such centers or other specialized institutions where their active component will be loaded periodically, can provide the centers as well as hospitals located close to such center, with the eluate and cold kits (or the synthesized complexes of kits) for producing radiopharmaceuticals.

The first phase of clinical trials of several pharmaceuticals labeled with Re-188 has been performed in Germany and England. Generator of W-188/Re-188 of activity of up to 1 Ci was used for this purpose. However, there are no commercial W-188/Re-188 generators or cold kits to them in catalogues. Besides, due to the low concentration activity generators of 1 Ci cannot be used for the centralized delivery of Re-188 eluate to specialized hospitals. That is why the development of W-188/Re-188 medical generator of activity of up to 5 Ci is an emergent task.

The following tasks are suggested to be solved in order to create the basis for complete production cycle of stationary medical generator of W-188/Re-188 and cold kits to them:

– develop a production method of the raw material of high specific activity in the high-flux reactor SM;


– perform R & D work for selecting optimum procedure of the separation of tungsten and rhenium compounds;
– develop a design of the stationary generator and a procedure of its loading;
– develop an experimental generator of high activity W-188/Re-188 and optimize its quality parameters for application under stationary conditions of a medical institution;
– develop methods of quality control of the eluate produced by generator of this type;
– perform medical & biological and pre-clinical trials of the eluate of W-188/Re-188 generator;
– develop an effective method of labeling Re-188 pharmaceuticals on the basis of diphosphonic acid and albumin microspheres;
– develop cold kits with optimum composition to Re-188 generator on the basis of diphosphonic acid and albumin microspheres;
– investigate the complexing conditions of Re-188 with diphosphonic acid and albumin microspheres, to study stability of the pharmaceuticals;
– produce experimental samples of the cold kits and to study the reproducibility of their characteristics;
– perform preliminary biological trials for evaluating functional usefulness of the pharmaceuticals.

At present there is no production of W-188/Re-188 generators up to 5 Ci for medical application, and cold kits to them haven’t been developed yet. So the development of generators and cold kits on the basis of diphosphonic acid and albumin microspheres as well as biological research for evaluating efficiency of the pharmaceuticals are topical tasks.

The project participants have at their disposal technical means as well as scientific potential for solving these topical tasks, namely:

– high flux reactor SM-3 is available in Russia (RIAR), it is used for the raw material production;


– work experience and technical equipment for loading generators of short-lived isotopes (SSC RF IPPE);
– skill level and experimental equipment (MRRC RAMS).

The complex research will make it possible to take the next step forward in the evolution of radiopharmacy due to the development of radiopharmaceuticals of new generation as well as new medical procedures of therapy on their basis.

This research will contribute to reorientation of scientists formerly associated with defense (weapons) development in the field of physics and chemistry of fission materials and reactor technology for solving problems in the area of radiopharmaceutics, chemistry, bio-chemistry and radionuclide therapy.


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