V. Minkov et al., Application of radioactive substances in research in nuclear medicine: current trends and radiation exposure to the study subjects, NUKLEARMED, 40(4), 2001, pp. 116-121
Aim: Analysis of the application of radioactive substances in research in t
he field of nuclear medicine in human beings and of the resulting radiation
exposure to study subjects. Methods: Assessment of applications for approv
al submitted is accordance with Paragraph 41 of the Radiation Protection Or
dinance, evaluated by the Federal Office for Radiation Protection together
with the Federal Institute for Pharmaceuticals and Medical Products, within
the period from 1997 to 1999. Results: The focus of the studies on the dia
gnostic application of radioactive substances in medicine evaluated has, si
nce 1998, shifted from oncological to neurological and psychological aspect
s, while, at the same time, the number of PET studies increased constantly.
The proportion of healthy study subjects included in the diagnostic studie
s increased from 7 to 22%. The number of therapeutic applications of radioa
ctive substances has, since 1997, undergone a three-fold increase, and in t
he process of this, the focus of attention lay within the area of radioimmu
no-therapy and endovascular brachytherapy The effective dose was, among up
to 49% of the investigated healthy study subjects higher than 5 mSv, and am
ong up to 6% of these subjects was at levels of over 20 mSv. Up to 22% of t
he patients received, within the scope of diagnostic studies, an effective
dose of between 20 and 50 mSv. An exceeding of the 50 mSv limit occurred am
ong up to 3% of the patients. Conclusions: In spite of the increasing numbe
rs of PET applications, conventional nuclear medicine has maintained its im
portance in the field of medical research. Further developments in the area
s of radiochemistry and molecular biology led to an increase in the importa
nce of radio-immuno therapy. The evaluation of new radiopharmaceuticals and
the extension of basic biomedical research, resulted in an increase in the
proportion of healthy study subjects included in the studies. The radiatio
n exposure among subjects resulting directly from the studies showed, for t
he period of evaluation, an overall trend towards reduction.