Rep 809

CHAPTER ONE

INTRODUCTION

The IAEA’s Statute authorizes the Agency to “establish or adopt standards of

safety for protection of health and minimization of danger to life and property” —
standards that the IAEA must use in its own operations, and which States can apply
by means of their regulatory provisions for nuclear and radiation safety. The IAEA
does this in consultation with the competent organs of the United Nations and with
the specialized agencies concerned. A comprehensive set of high quality standards
under regular review is a key element of a stable and sustainable global safety
regime, as is the IAEA’s assistance in their application.

The IAEA commenced its safety standards programme in 1958. The emphasis
placed on quality, fitness for purpose and continuous improvement has led to the
widespread use of the IAEA standards throughout the world. The Safety Standards
Series now includes unified Fundamental Safety Principles, which represent an
international consensus on what must constitute a high level of protection and
safety. With the strong support of the Commission on Safety Standards, the IAEA
is working to promote the global acceptance and use of its standards.

Lessons that may be learned from studying the accident at the Fukushima Daiichi
nuclear power plant in Japan following the disastrous earthquake and tsunami of
11 March 2011 will be reflected in this IAEA safety standard as revised and issued
in the future.

Radiation Protection and Safety of Radiation Sources: International Basic Safety

Standards are jointly sponsored by the European Commission (EC), the Food and

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Agriculture Organization of the United Nations (FAO), the IAEA, the International
Labour Organization (ILO), the OECD Nuclear Energy Agency (OECD/NEA), the
Pan American Health Organization (PAHO), the United Nations Environment
Programme (UNEP) and the World Health Organization

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 CHAPTER TWO

It is a general consensus that ionizing radiation is oncogenic in nature. Much of

this agreement is based upon observation of increased incidence of carcinoma in a
population surviving a nuclear attack or in uranium miners exposed to radiation at
the workplace. The amount of radiation used by imaging modalities is negligible as
compared to the abovementioned exposures. For instance, in the United States,
people are exposed to average annual background radiation levels of about 3 mSv;
exposure from a chest X-ray is about 0.1 mSv, and exposure from a whole-body
computerized tomography (CT) scan is about 10 mSv, and that’s one of the reasons
why physicians usually miscalculate the potential risks associated with the
radiation exposure while performing procedures using radiologic imaging. This
article will attempt to explain how to quantify radiation, the biological effect of
radiation, risks to health care workers as a result of radiation exposure, and certain
recommendations and tips for various medical professionals.
Radiation is defined as a moving form of energy. It can be classified into two
categories, i.e., ionizing and non-ionizing type. Ionizing radiations can be further
classified into electromagnetic radiation (matter less) and particulate radiation.
 The primary responsibility for ensuring overall radiological protection
of patients
Because of the medical setting in which medical exposures occur, primary
responsibility for radiation protection and safety for patients lies with the health
professional responsible for the radiological procedure, who is referred to in GSR
Part 3 as the ‘radiological medical practitioner’. The term radiological medical
practitioner is the generic term that GSR Part 3 uses to refer to a health

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professional with specialist education and training in medical uses of radiation,
who is competent to perform independently or to oversee procedures involving
medical exposure in a given specialty. Health professionals that could take on the
role of the radiological medical practitioner, depending on the particular use of
radiation and on the laws and regulations in a State, include radiologists, nuclear
medicine physicians, radiation oncologists, cardiologists, orthopedic surgeons,
other specialist physicians, dentists, chiropractors and podiatrists.
The medical physicist has responsibilities in the optimization of radiation
protection and safety in medical exposures, including source calibration, clinical
dosimetry, image quality and patient dose assessment, and physical aspects of the
quality assurance programme, including medical radiological equipment
acceptance and commissioning. The medical physicist is also likely to have
responsibilities in providing radiation protection and safety training for health
professionals. In addition, he or she may also perform the role of the radiation
protection officer, whose responsibilities are primarily in occupational and public
radiation protection.
 BASIS FOR THESE STANDARDS

In the system of international intergovernmental organizations, the first endeavour

by the IAEA to establish international standards for radiation protection and safety
was made in the 1950s. The Board of Governors of the IAEA first approved health
and safety measures in March 19601, when it was stated that “The Agency’s basic
safety standards...will be based, to the extent possible, on the recommendations of
the International Commission on Radiological Protection (ICRP)”. The Board of
Governors of the IAEA first approved Basic Safety Standards in June 1962; they
were published by the IAEA as IAEA Safety Series No. 92.

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A revised edition was issued in 19673. A third revision was published by the IAEA
as the 1982 Edition of IAEA Safety Series No. 94; this edition was jointly
sponsored by the IAEA, ILO, OECD/NEA and the WHO. The next edition was
International Basic Safety Standards for Protection against Ionizing Radiation and
for the Safety of Radiation Sources, published by the IAEA as IAEA Safety Series
No. 115 in February 19965, and jointly sponsored by the FAO, IAEA, ILO,
OECD/NEA, PAHO and the WHO.

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 CHAPTER THREE

PRINCIPLES OF JUSTIFICATION AND OPTIMIZATION

The process of justification allows determining whether the medical exposure will
take place or not. The goal of justification is to avoid unnecessary radiological
procedure, which would result in patient being unnecessary exposed to ionizing
radiation and its potential risks.
First, a given radiological procedure shall be justified. This applies to the
justification of new technologies and techniques as they evolve. This generic
justification shall be carried out by the health authority in conjunction with
appropriate professional bodies.
The justification of medical exposure for an individual patient shall be carried out
by means of consultation between the referring medical practitioner (who initiates
the request for a radiological procedure) and the radiological medical practitioner
(who is responsible for performing a procedure). A referral should be regarded as a
request for a professional consultation or opinion rather than an instruction or order
to perform. The referring medical practitioner brings the knowledge of the medical
context and the patient’s history to the decision process, while the radiological
medical practitioner has the specialist expertise on the radiological procedure.
Therefore, the joint approach is required to justification and shared decision at the
level of an individual patient considering:
 The appropriateness of the request;
 The urgency of the procedure;
 The characteristics of the exposure and of the individual patient;
 The relevant information from any previous procedures;
 The relevant referral guidelines.

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  What guidance is available to help medical practitioners justify the
individual patient exposure:
The process of determining appropriateness of a medical procedure is an evidence
based approach to choosing the best test for a given clinical scenario, with account
taken of the diagnostic efficacy of the proposed radiological procedure as well as
of alternative procedures that do not use ionizing radiation, for example,
ultrasound, magnetic resonance imaging (MRI) or endoscopy.
Useful tools to support this decision making process include national or
international imaging referral guidelines developed by professional societies.
Imaging referral guidelines can be disseminated or utilized through electronic
requesting systems and clinical decision support tools or systems. It should be
ensured that such systems correctly apply the regulatory requirements for
justification, in particular with respect to roles and responsibilities.
In determining the appropriateness of the radiological procedure for an individual
patient, the following questions should be asked by the referring medical
practitioner:
 Has it been done already?
 Is it needed?
 Is it needed now?
 Is this the best investigation to answer the clinical question?
 Has the clinical problem been explained to the radiological medical
practitioner?
 Requirements to justify exposures for health screening of population or
exposures of humans for research:

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Justification for radiological procedures to be performed as part of a health
screening programs for asymptomatic populations shall be carried out by the health
authority in conjunction with appropriate professional bodies.
Any radiological procedure on an asymptomatic individual that is intended to be
performed for the early detection of disease, but not as part of an approved health
screening programs, shall require specific justification for that individual by the
radiological medical practitioner and the referring medical practitioner, in
accordance with the guidelines of relevant professional bodies or the health
authority. As part of this process, the individual shall be informed in advance of
the expected benefits, risks and limitations of the radiological procedure.
The medical exposure of volunteers as part of a programs of biomedical research is
deemed to be not justified unless:
(A) It is in accordance with the provisions of the Helsinki Declaration and takes
into account the guidelines published by the Council for International
Organizations of Medical Sciences, together with the recommendations of the
International Commission on Radiological Protection (ICRP);
(B) It is subject to approval by an ethics committee (or other institutional body that
has been assigned functions similar to those of an ethics committee by the relevant
authority), subject to any dose constraints that may be specified, and subject to
applicable national regulations and local regulations.

 Optimization of medical exposure is ensured and who is responsible:

Once justified, the radiological procedure should be optimized and performed such
that the exposure of the patient is managed in order to achieve the medical
objective.

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Too low radiation dose could be as bad as too high radiation dose. As a
consequence, cancer is not cured or the images taken are not of a suitable
diagnostic quality. The medical exposure should always lead to the required
clinical outcome.
Optimization is a prospective and iterative process that requires judgments to be
made using both qualitative and quantitative information. The following aspects
and tools have to be used to ensure optimization of protection and safety:
 Appropriate design of medical radiological equipment and software;
 Operational considerations specific to the modality and application;
 Calibration of sources and dosimeters;
 Quality assurance program implemented and independent audits made of
this program;
 Dissymmetry of patients to determine typical doses to patients for common
diagnostic and image guided interventional procedures, and absorbed doses
to the planning target volume and relevant organs for each patient in
radiotherapy;
 Diagnostic reference levels established and used for most common
diagnostic procedures.
 Dose constraints used in the optimization of protection and safety for
persons acting as careers or comforters, or subject to exposure as part of a
programs of biomedical research.

 Perspective of the ICRP in Justification

ICRP recommendation for radiological protection and safety in medicine are
giving in publication 105 (ICRP, 2007) which explain justification at 3 levels

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  level 1 : use of radiation in medicine regarded as more good than harm to
society
 level 2 : for a specified procedured for a group of patients with relevant
symptoms
 Level 3: the application of specified procedure to an individual patient
Special considerations should be made for the optimization of protection and safety
of patients who are:
 Pregnant
 Breast-feeding
 Children.

 Collimation

Collimation" refers to all the optical elements in an instrument being on their

designed optical axis. It also refers to the process of adjusting an optical instrument
so that all its elements are on that designed axis (in line and parallel).

A collimated beam of light or other electromagnetic radiation has parallel rays, and
therefore will spread minimally as it propagates. A perfectly collimated light beam,
with no divergence, would not disperse with distance. However, diffraction
prevents the creation of any such beam.

Acute Radiation Syndrome

Acute radiation syndrome involves extreme cases of radiation exposure and it is
difficult to envision such exposure from environmentally generated radon and its
daughters. When it does occur, however, it appears to progress in four stages:
prodome, latent, manifest illness, and recovery. The prodome phase occurs ∼48–

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72 h post exposure and is characterized by nausea, vomiting, diarrhea, intestinal
cramps, salivation, and dehydration with accompanying neurovascular
dysfunction, which includes fatigue, weakness, apathy, fever, and hypotension.
During the latency period, exposure of the bone marrow results in decreased cell
counts that are dose dependent. This period lasts from 1 to 2.5 weeks. Major organ
damage can occur during this phase and extends into the manifest illness phase that
results in either recovery or death.

Whole Body Radiation Injury

Brief exposure of a major part of the body to more than 1 Sv may cause acute
radiation syndrome, which is characterized by (1) an initial prodromal stage of
malaise, anorexia, nausea, and vomiting; (2) an ensuing latent period; (3) a second
(main) phase of illness; and (4) either recovery or death (see Table 19-3). The main
phase of the illness usually takes one of four primary forms—hematologic,
gastrointestinal, neurovascular, or pulmonary—depending on the size and
anatomic distribution of the dose.

CHAPTER FOUR
1. The use of specific radiotracers called radiopharmaceuticals for imaging organ
function and disease states is a unique capability of nuclear medicine. Unlike other
imaging modalities such a Computed Tomography (CT), Magnetic Resonance
Imaging (MRI) and Ultrasonography (US) nuclear medicine procedures are
capable of mapping physiological function and metabolic activity and thereby
giving more specific information about the organ function and dysfunction (1). The

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mapping of the radiopharmaceutical distribution in vivo provides images of
functional morphology of organs in a non-invasive manner and plays an important
role in the diagnosis of many common diseases associated with the malfunctioning
of organs in the body as well as in the detection of certain type of cancers. The
widespread utilization and growing demands for these techniques are directly
attributable to the development and availability of a vast range of specific
radiopharmaceuticals.
B. Radioisotopes for Radiopharmaceuticals: History and Growth
2. Radiopharmaceuticals are medicinal formulations containing radioisotopes
which are safe for administration in humans for diagnosis or for therapy. Although
radiotracers were tried as a therapeutic medicine immediately after the discovery of
radioactivity, the first significant applications came much later with the availability
of cyclotrons for acceleration of particles to produce radioisotopes. Subsequently,
nuclear reactors realised the ability to prepare larger quantities of radioisotopes.
Radioiodine (iodine-131), for example, was first introduced in 1946 for the
treatment of thyroid cancer, and remains the most efficacious method for the
treatment of hyperthyroidism and thyroid cancer.
3. One of the major goals for setting up nuclear research reactors was for the
preparation of radioisotopes. Among the several applications of radioisotopes,
medical applications were considered to be of the highest priority. Most of the
medium flux and high flux research reactors now are routinely used to produce
radioisotopes for medical, and also industrial, applications. The most commonly
used reactor produced isotopes in medical applications are molybdenum-99 (for
production of technetium-99m), iodine-131, phosphorus-32, chromium-51,
strontium-89, samarium-153, rhenium-186 and lutetium-177 (2).

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4. The early use of cyclotron in radiopharmaceuticals field was for the production
of long lived radioisotopes that can be used to prepare tracers for diagnostic
imaging. For this, medium to high energy (20-70 MeV) cyclotrons with high beam
currents were needed. Isotopes such as thallium-201, iodine-123 and indium-111
were prepared for use with single photon emission computed tomography
(SPECT). With the advent of positron emission tomography (PET), there has been
a surge in the production of low energy cyclotrons (9-19 MeV) exclusively for the
production of short lived PET radionuclides such as fluorine-18, carbon-11,
nitrogen-13 and oxygen-15.
C. Radiopharmaceuticals Production Aspects and Challenges
5. Currently there are over 100 radiopharmaceuticals developed using either
reactor or cyclotron produced radioisotopes and which are used for the diagnosis of
several common diseases and the therapy of a few selected diseases, including
cancer. Radiopharmaceuticals production involves handling of large quantities of
radioactive substances and chemical processing. Aspects which need to be
addressed in radiopharmaceuticals production, including the management of
radioisotope production, include import, operation and maintenance of processing
facilities, complying with the codes of current good manufacturing practices
(cGMP), ensuring effective quality assurance and quality control (QA & QC)
systems, registration of the products with national/regional health authorities and
radioactive material transport etc.
6. Radiopharmaceuticals production, unlike conventional pharmaceuticals
production, is still on a relatively small scale and implementing the cGMP
guidelines which are applicable for the drugs industry is both difficult and
expensive. Ensuring cGMP compliance is a demanding task for a small scale

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manufacturer, as it involves taking care of several aspects prior to, during and after
production.
These include the development of well qualified personnel, use of controlled
materials and procedures, availability of qualified equipment, production of the
products in designated clean areas, applying validated processes and analytical
methods, full documentation of the process and release of the final product by a
qualified person. Application of clean room requirements in radioisotope
laboratories in general and hot cells in particular (Fig. 2), is technically demanding
to be compatible with the requirements for both radiological and pharmaceutical
safety. The Agency assists its Member States to improve the radiopharmaceuticals
production to meet cGMP as adaptable to radioactive products by providing
appropriate documents, conducting training courses and supporting technical
cooperation projects.

CHAPTER FIVE

There are approximately 1,000–1,200 registrations of squamous carcinoma of the

anus per year in the UK. Despite its rarity, a succession of phase III trials have
been conducted which have established the standard treatment of this disease;
radical treatment with chemoradiotherapy allowing sphincter preservation.

Radical treatment

Both the United Kingdom Co-ordinating Committee on Cancer Research

(UKCCCR) anal cancer trial (45 Gray [Gy] in 20 or 25 fractions with a boost) and
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an European Organisation for Research and Treatment of Cancer (EORTC) trial
demonstrated improved outcome for concomitant chemoradiotherapy using
mitomycin C and 5-fluorouracil (5-FU) when compared with radiotherapy
alone.1,2 A statistically significant reduction in locoregional failure was
demonstrated in both trials. A further phase III trial performed by the Radiotherapy
Oncology Group (RTOG) demonstrated improved colostomy-free survival when
mitomycin C was added to 5-FU chemoradiation.3 Chemo radiotherapy improves
outcome in anal cancer compared to radiotherapy alone (Level 1b).4 The
UKCCCR ACT2 trial compared concomitant mitomycin C and 5-FU with cisplatin
and 5-FU when combined with a two-phase radiotherapy technique delivering a
total dose of 50.4 Gy in 28 fractions.5 A second randomisation tested the role of
two subsequent cycles of cisplatin 5-FU chemotherapy against no further
treatment. There was no significant difference between concurrent chemotherapy
regimens, and no progression-free survival benefit to the addition of adjuvant
chemotherapy (Level 1b).4 The EXTRA trial was a phase II study substituting
capecitabine for 5-FU chemotherapy that reported minimal toxicity and acceptable
compliance.6 Substitution of 5-FU with capecitabine has been thoroughly
investigated in other tumor sites and the two drugs have been proven to be equally
effective (Level 2b).4

Treatment technique

The phase 2 RTOG 0529 trial treated patients with inverse planned intensity-
modulated radiotherapy (IMRT) and reported reduced toxicity to that seen in the
RTOG 9811 trial where standard conformal radiotherapy techniques were used
(Level 2b).4,7,8 It is recommended that a standard atlas for delineating volumes is
used for IMRT or arc radiotherapy. Expert opinion was sought from a number of

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UK clinicians to create a consensus guideline which is based on ACT II volumes
but adapted for inverse planning.9,10 Node positive patients Analyses of both the
UKCCR ACT II and RTOG 9811 trial have highlighted that locally advanced and
node-positive tumours have a significantly reduced disease-free survival and
overall survival.5,8 As a result, current guidance and recent trials have used a
higher dose for these patients when using IMRT or arc radiotherapy.

However, due to the excellent outcomes in ACT II in node-negative cancers, the

recommended prophylactic nodal dose remains the same and has been calculated to
deliver the same biologically effective dose over 28 fractions with IMRT or arc
radiotherapy which was previously delivered over 17 fractions during standard 2-
phase radiotherapy(Level 5).4,11

The Personalising Anal Cancer Radiotherapy Dose (PLATO) trial looking at dose
escalation in locally advanced anal cancers and dose de-escalation in early small-
node negative tumours is currently in set up in the UK and will inform dose
fractionation for anal cancers in the future.12

 Palliative treatment

There are no good-quality trials evaluating different dose fractionation schedules

for palliative treatment. An appropriate regime should be chosen after considering
the patient’s likely prognosis, disease burden, symptoms and performance status.

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SUMMARY

Radiation protection is a highly organized field that is saddle with responsibility of

protecting humans, animals and the environment from the harmful effects of
radiation while promoting its peaceful use.

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CONCLUSION

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The government should encourage the training of Qualified and the interested staff
to partake in the field nuclear medicine radiotherapy and radio diagnosis which is a
new field in modern profession of medicine locally.

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