Production of 18F-fluorcholine and the FLT at IPEN will enable a greater number of diagnoses of early tumors
A pioneer in the production of molecules labelled with F-18 and Ga-68, for studies in Oncology for PET-CET, IPEN will provide large-scale two markers for prostate tumors and breast.
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Two new radiopharmaceuticals, the Fluorcolina-18F and the Fluortimidina-18F (FLT), used in PET-CT (positron emission tomography-computed tomography) for early detection of tumours, will begin to be produced in the Radiofarmácia Center (CR) of IPEN, São Paulo. Indicated for the diagnosis in prostate tumor, the Fluorcolina is in final stage of production, with human clinical tests forecast in August, and the hospitals Alto da XV, in Curitiba (PR), and Antonio Prudente Foundation A.C. Camargo, in São Paulo, precursors to applying this new technique.
"The sending of the first doses of the Fluorcolina is depending on the approval by the Ethics Committee of these two institutions. After a year of hard work, we can get out of the research stage – the stage of preclinical – production. But, to administer in humans, which is the clinical phase, it is necessary to have the approved research protocol. Despite the low risk of this procedure, at this stage, the patient must sign a document of science and only then the medicine is injected, "said Regina Celia Lamb, of the CR.
With respect to application of the FLT, where a larger number of tumors can be diagnosed, including non-Hodgkin Lymphoma, lung, breast proliferation, Oropharynx, acute myeloid leukemia, preclinical tests, performed on cells and animals, have already been completed. According to Regina, the next step is the implementation of the research to the production, when the medicine will also be injected into patients. "This implementation doesn't take long, and by December of this year we will start distributing FLT to those same hospitals and perhaps to others. The demand in the country is huge and other institutes of the CNEN, from the pioneering spirit of IPEN, can produce this radiopharmacology ".
Radioactive processes, the half-life (or period of semi disintegration) of a radioisotope is the time it takes to decay to half the initial activity of this radioisotope, which can occur in seconds or in billions of years. In the case of Fluorine-18, both of Fluorcolina when the FLT, the half-life is 109 minutes. This F-18 is produced in accelerators like Cíclotrons by reaction of O-18 enriched water with protons produced by this gas. The priority, according to Regina Ribeiro Balogun, is to start studies with hospitals and clinics of nuclear medicine of São Paulo and nearby regions
Priorities
The Fluorcolina is specific for the early diagnosis of prostate cancer. According to the National Cancer Institute (INCA), this cancer is the second most common among men and, in absolute values, is the fourth in the world, accounting for approximately 10% of all tumors. Due to more advanced diagnostic methods and the increase in life expectancy, the number of cases has increased in whole world. In Brazil, is no different: the estimate of the INCA is 61,200 new cases for 2016.
The FLT, although nominated for several types of tumors, the priority, according to Regina, will be produced with the objective of diagnosing breast cancer, the most common among women in the world and in Brazil, after the non-melanoma skin cancer, accounting for about 25% of new cases each year. Early diagnosis is crucial, because some types evolve very quickly. The estimated new cases is 57,960 for 2016, according to the INCA.
"Brazil does not yet have end markers for breast and prostate tumor". The IPEN, fulfilling its mission, established goals to achieve the objective of production of FLT, in which are involved the CR and the CYCLOTRON, "said the researcher.
Pioneer in Brazil
The IPEN pioneered the production of molecules labelled with F-18 and Ga-68, for studies in Oncology for PET-CET, and opened the market to other producers in the country. The 18F FDG, or F-18 Fluordeoxiglicose, Dotatato 68Ga (staging of endocrine tumors) and the Fluoride 18F (staging of bone metastasis) are the only radiopharmaceuticals that Brazil has to be used in molecular imaging with Positron Emission Tomography (PET/CT), currently the most modern method for the detection of tumors and other diseases such as neurological problems.
In fact, are two types of scans, PET and CT, which, when performed together, allow a very detailed view of metabolism and Anatomy of the tumor. Since April 2014, the 18F-FDG has become embedded in the procedures of the single health system (SUS) to four types of tumors: Lung metastasis of colorectal cancer, Hodgkin's lymphoma and non-Hodgkin's lymphoma also.
Currently, in Brazil, there are around 112 PET-CT equipment and 10 production centers capable of producing molecules labelled with Fluorine-18, with a geographical distribution proportional to population density in the country.
"The commitment of the Radiofarmácia Center of IPEN is introducing new radiopharmaceuticals so that an increasing number of patients can have access to nuclear medicine procedures, thus increasing the survival rate and improving the quality of life of the same", stressed the CR Manager, Jair Mengatti (see page 8).
According to him, the Fluorcolina and production of FLT are achievements that will expand the number of patients who will have their tumors diagnosed early increasing the success of therapy. "This reflects the importance of IPEN on public health," he added.
For the Director of Nuclear Medicine and PET-CT of the Bc Cancer Center doctor Camargo Eduardo Nóbrega Parry, the IPEN has an essential contribution to nuclear medicine in Brazil, especially when this specialty can reach a growing number of users. Since 1992 in function, it appears optimistic about testing.
"Like cancer institution, is always positive to enlarge the possibilities of examinations. We'll use what we already have today versus the information provided by the new, in order to confirm whether there will be gains in diagnosis. We know a priori, Yes. Then, from there, we're going to establish when and how the drug should be used in the analysis of patients with prostate cancer, for example; not all, only suspects of recurrence of the disease.
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Also available in Orbit May-June 2016
