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Radiol med (2012) 117:1347–1354

DOI 10.1007/s11547-012-0881-z

MUSCULOSKELETAL RADIOLOGY
RADIOLOGIA MUSCOLO-SCHELETRICA

Quality assurance of imaging techniques used in the clinical


management of osteoporosis

Controllo di qualità delle tecniche di imaging nella gestione clinica


dell’osteoporosi

G. Guglielmi1, 2 • J. Damilakis3, 4 • G. Solomou3, 4 • A. Bazzocchi5, 6

1
Department of Radiology, University of Foggia, Viale Luigi Pinto 1, 71100 Foggia, Italy
2
Department of Radiology, Scientific Institute “Casa Sollievo della Sofferenza” Hospital, Viale Cappuccini 1, 71013 San Giovanni
Rotondo (FG), Italy
3
University of Crete, Faculty of Medicine, Department of Medical Physics, P.O. Box 2208, 71003 Heraklion, Crete, Greece
4
University Hospital of Heraklion, Department of Medical Physics, P.O. Box 1352, 71110 Heraklion, Crete, Greece
5
Imaging Division, Clinical Department of Radiological and Histocytopathological Sciences, University of Bologna, Sant’Orsola,
Malpighi Hospital, Via G. Massarenti 9, 40138 Bologna, Italy
6
Diagnostic and Interventional Radiology, “Rizzoli” Orthopaedic Institute, Via G.C. Pupilli 1, 40136 Bologna, Italy
Correspondence to: G. Guglielmi, Department of Radiology, University of Foggia, Viale L. Pinto 1, 71100 Foggia, Italy, Tel.: +39-
0881-733866, Fax: +39-0881-350368, e-mail: g.guglielmi@unifg.it

Received: 12 July 2012 / Accepted: 24 July 2012 / Published online: 22 October 2012
© Springer-Verlag 2012

Abstract Riassunto
Recent advances in the densitometric and imaging I recenti progressi nelle tecniche di densitometria e di
techniques involved in the management of osteoporosis are imaging nella diagnosi dell’osteoporosi sono associati ad
associated with increasing accuracy and precision as well una crescente accuratezza e precisione così come ad una
as with higher exposure to ionising radiation. Therefore, maggiore esposizione a radiazioni ionizzanti.
special attention to quality assurance (QA) procedures In questo campo è pertanto richiesta una particolare
is needed in this field. The development of effective and attenzione alle procedure di controllo di qualità (Quality
efficient QA programmes is mandatory to guarantee Assurance, QA). Lo sviluppo di programmi di QA efficaci
optimal image quality while reducing radiation exposure ed efficienti è necessario al fine di garantire una qualità
levels to the ALARA principle (as low as reasonably dell’immagine ottimale e al contempo di ridurre i livelli
achievable). In this review article, the basic QA procedures di esposizione alle radiazioni secondo il principio ALARA
are discussed for the techniques applied to everyday (cioè al livello più basso ragionevolmente ottenibile). In
clinical practice. questa review sono trattate le procedure base di QA per
le metodiche di imaging adoperate nella pratica clinica
Keywords Osteoporosis · Bone densitometry · DXA · quotidiana.
QCT · QUS · Bone structure

Parole chiave Osteoporosi · Densitometria ossea · DXA ·


QCT · QUS ·Struttura ossea

Introduction

Osteoporosis is a skeletal disease, characterised by low sceptibility to fracture [1]. This disease is widely recognised
bone mass and micro-architectural deterioration of bone as an important public health problem because of the signi-
tissue, with a consequent increase in bone fragility and su- ficant morbidity, mortality and economic and social costs
1348 Radiol med (2012) 117:1347–1354

associated with its complications, i.e., fractures at different Equipment and installation
skeletal sites [2]. The percentage of patients with osteoporo-
sis increases progressively with age and the disease occurs The technical features of bone densitometry and other re-
more frequently among females. Fractures tend to occur in lated medical devices should satisfy clinical requirements.
those bone parts, such as the vertebral body, hip and wrist, The supplier of the equipment should describe all clinical
which rely heavily on trabecular bone for their strength [3, applications of the system and specify the performance in
4]. It is estimated that every year 9 million osteoporotic terms of accuracy and precision. DXA and QCT should
fractures affect the worldwide population, and more than be supplemented with a reference database to compare pa-
half of these occur in Europe and in the Americas [5, 6]. tients’ measured BMD with that of age- and sex-matched
Osteoporotic fractures cost 36 billion euro in Europe and 18 normal subjects and with normal young adults. Equipment
billion dollars in the US every year, and these are expected packages should include not only the specific application
to increase twofold or more by 2050 unless treatments are software package but also dedicated phantoms for calibra-
pursued that have a significant impact on the global burden tion and quality control procedures.
of fractures [7, 8]. The installation of the equipment should be followed by
Quality assurance (QA) is by definition a programme procedures that ensure proper functioning, satisfy all current
for the systematic monitoring and evaluation of the various radiation protection requirements and manufacturer speci-
aspects of a service or facility to ensure that standards of fications. Radiation safety checks should be performed by
quality are being met. QA in bone densitometry and asso- a medical physics expert. Electrical safety tests, equipment
ciated methods is composed of those actions aiming to (1) tests and staff training should be provided by the supplier
maintain adequate equipment performance with the lowest of the equipment; the employer should verify if equipment
possible radiation dose to patients consistent with clinical tests and staff training have been performed on the newly
imaging requirements and (2) assure that adequate diagno- installed equipment [9].
stic information is provided at the lowest possible cost. A
QA programme should include (a) guidelines and requi- Quality control
rements for equipment installation and its clinical use, (b)
standardised periodic tests developed to maintain diagnostic An important issue in the study of bone status is the esta-
quality (quality control, QC), (c) radiation safety policies blishment of sufficient QC procedures, performed to ensure
and procedures, (d) preventive maintenance procedures and that a manufactured product meets a defined and standardi-
(e) staff training and education. sed set of quality criteria. These procedures include monito-
Several methods have been developed to assess bone mi- ring of the stability and performance of the devices as well
neral status. Dual-energy X-ray absorptiometry (DXA) is as guidelines for the handling of error sources in order to
currently the most widely used method for the measurement guarantee reliable quantitative information to clinicians and
of areal bone mineral density (BMDa) (g/cm2). Quantitative patients as an aid to diagnosis and management of osteo-
computed tomography (QCT) allows separate assessment porosis.
of cortical and trabecular bone, providing volumetric bone
mineral density (BMD) (mg/cm3). Peripheral QCT (pQCT),
and high-resolution pQCT (HR pQCT) are CT-based tech- Dual-energy X-ray absorptiometry
niques dedicated to the study of appendicular sites of the
skeleton, with the aim of analysing both density and micro- DXA has a relevant and central role in the evaluation of
architectural bone properties. Moreover, quantitative ul- individuals at risk of osteoporosis, in helping clinicians to
trasound (QUS) and magnetic resonance (MR) techniques assess fracture risk and in patients with osteoporosis to se-
have been developed to assess bone quantity and quality. lect pharmacological therapy and to monitor treatment or
However, MR imaging is not discussed in this manuscript, disease progression [10].
since it is mainly limited to research fields. Vertebral fractu- Steps should be taken to make sure that a DXA device is
res are usually diagnosed on spine radiographs or images of of sufficiently high quality and that its accuracy and preci-
the spine acquired by DXA devices. sion is consistent with the manufacturer guidelines. Accura-
The use of diagnostic imaging methods for the assessment cy is the ability of a measurement to match the actual value
of bone status has constantly and quickly increased, so that of the quantity being measured and is expressed in terms of
QA in bone densitometry deserves special attention [9]. The accuracy error. Precision is the degree to which repeated
purpose of this review article is to summarise the current measurements under unchanged conditions show the same
practice of QA in bone densitometry and related techniques results. This is influenced by several parameters, such as
and to discuss the magnitude of radiation exposure from the skill and training of the technician performing the scan, the
X-ray methods used for the assessment of bone status. site of measurement and the clinical features of patients [9].
Radiol med (2012) 117:1347–1354 1349

To determine the accuracy of a DXA densitometer, a Precision is better for 3D multidetector QCT than for single-
phantom containing tissue-mimicking materials of known slice 2D QCT [17].
and different densities is scanned to ensure that measured QCT is based on analysis of the trabecular bone com-
values are truly assessed for all quantities under investiga- partment in the spine or proximal femur. Calibration is
tion [11]. The phantom represents the typical density ran- needed to convert CT numbers (Hounsfield Units, HU) to
ge and size of normal human spine. The accuracy error of grams per cubic centimeter. Most calibration approaches
DXA bone densitometers is better than 10% [12]. Phantom consist of a calcium hydroxyapatite-based bone mineral re-
measurements have to be performed every day, or at least 3 ference phantom that is scanned with the patient and placed
times a week. Results are entered into the QC database to underneath the lumbar spine or between the hips. Several
enable compensation of calibration changes. manufacturers have provided calibration standards along
To determine in-vitro precision of a DXA densitometer, with special software to define regions of interest and quan-
the phantom provided by the manufacturer for routine DXA tify BMD. The Image Analysis (Columbia, KY, USA) stan-
QC tests should be scanned multiple times. Precision is de- dard consists of rods with varying concentrations of calcium
pendent on population age and health status and is affected hydroxyapatite mixed in a water-equivalent solid resin ma-
by errors when BMD is evaluated in longitudinal studies. trix [18]. Another approach, phantomless calibration, uses
To overcome this limit and reduce precision errors, the ima- histograms of HU values placed in regions of subcutaneous
ges of previous DXA examinations should be used in mo- fat and skeletal muscle, assuming fixed properties for each
nitoring the accuracy of patient positioning. Of note, howe- tissue types to determine a HU calibration [17].
ver, is that the precision error estimated by the manufacturer
does not usually represent the error in the clinical setting.
Thus, every facility should determine in vivo reproducibili- Quantitative US
ty for each DXA device [13, 14].
It is well known that DXA devices developed by different Many QUS techniques have been developed for the mea-
manufacturers and even by the same manufacturer provide surement of broadband ultrasound attenuation (BUA) and
different BMD results when used to measure the same ske- speed of sound (SOS). Also an index indicative of bone
letal site of a patient because of differences in scanner de- stiffness is calculated from BUA and SOS. QUS measure-
sign, data acquisition, algorithms and method of calibration. ments are affected by precision errors due to patient posi-
To minimise differences between different DXA systems tioning, coupling between the transducer and the skin of the
cross-calibration techniques have been developed. The stan- patients, and the effect of soft tissue properties. Therefore
dardised BMD (sBMD) has been introduced to distinguish QC procedures regularly performed with specific phantoms
interchangeable BMD from manufacturer-specific BMD are required for performance monitoring and stability check
[15, 16]. Although sBMD values can reduce the differences of the devices [9, 19, 20]. A phantom should emulate the in
between measurements performed by systems developed by vivo measurement as much as possible in terms of geometry
different manufacturers to less than 6%, the use of different and acoustic properties.
DXA systems to longitudinally monitor the bone status of The differences in measurements between available QUS
an individual is not recommended. equipment are greater than those between DXA devices;
this is due to the different transducers and frequency ranges
[21].
Quantitative CT

The QA of CT systems is recognised as an important to- Radiation dosimetry


pic and scientific and professional organisations have de-
veloped guidelines for equipment specifications, equipment A bone densitometry QA programme should involve perio-
QC tests and radiation safety [17]. Radiation safety in CT dic checks and measurements to maintain diagnostic image
is emphasised because patient radiation doses from CT are quality at the lowest possible radiation exposure.
considerably higher than those from DXA.
The measurement of precision is influenced by the CT Quantities and units
scanner model, QCT method, skill of the radiological
technologist, patient positioning and movement. Each faci- The two most frequently used radiation quantities in dia-
lity should perform precision testing to determine precision gnostic radiology are absorbed dose (AD) and effective
error and calculate the least significant change. If a facility dose (ED). The AD, expressed in grays (Gy), is a measure
has more than one user technologist, these values should of the energy per unit of mass deposited in the tissue and
represent an average of pooled data from all technologists. organs of the exposed body. The ED, expressed in sieverts
1350 Radiol med (2012) 117:1347–1354

(Sv), is calculated using organ or tissue absorbed doses and Table 1 Adult effective doses for spine radiographs (from Damilakis et al.
[9], with permission)
the relative radiosensitivity assigned to each of these organs
or tissues, defined by the International Commission on Ra- Tabella 1 Dosi effettive nei soggetti adulti per radiogrammi del rachide
diological Protection (ICRP) [22]. dorso-lombare (da Damilakis et al. [9], con autorizzazione)
The ED was introduced to allow comparison of the risk
Effective dose
estimates from different sources of ionising radiation, for (μSv)
example from DXA and QCT, or from imaging techniques
and natural background radiation. The annual worldwide Thoracic spine AP 0.4
Thoracic spine LAT 0.3
average ED from natural background radiation is 2.4 mSv
Lumbar spine AP 0.7
[9]. Lumbar spine LAT 0.3
Dosimetric quantities used in CT are the CT dose index
(CTDI) and the dose-length product (DLP) [9]. The CTDI AP, anterior-posterior; LAT, lateral
represents the average absorbed dose, along the z axis, from
a series of contiguous exposures. CTDI measurements are Table 2 Adult effective doses for various diagnostic X-ray examinations
(from Mettler et al. [31], with permission)
performed at the periphery and at the centre of cylindrical
phantoms representing the human head and body by using Tabella 2 Dosi effettive nei soggetti adulti per vari esami di diagnostica a
a pencil ionisation chamber with a length of 100 mm. From raggi X (da Mettler et al. [31], con autorizzazione)
these measurements, a weighted CTDI (CTDIw) represen-
Examination Effective
ting the average dose to a single slice is obtained. Moreo- dose
ver, CTDI volume (CTDIv) has been introduced to take into (μSv)
account the effect of pitch on radiation dose, for imaging
performed in the spiral mode, which is defined as CTDIw Panoramic dental radiography 0.01
Chest radiography (posterior-anterior) 0.02
divided by pitch. The DLP is defined as the CTDIv multi-
Chest radiography (posterior-anterior and lateral) 0.1
plied by the imaging length (mGy×cm). Thus, DLP is an Mammography 0.4
indicator of the integrated dose of an entire CT examination. Abdominal radiography 0.7
Broad estimates of effective dose E can be derived from Chest CT 7
DLP values using conversion coefficients: E=DLP×k whe- Abdominal CT 8
Coronary percutaneous transluminal angioplasty,
re k is body region–specific normalised ED factors (mSv*
stent placement, or radiofrequency ablation 15
mGy−1*cm−1) [23].
CT, computed tomography
Patient exposure
technique, X-ray tube filtration, efficiency of detection sy-
DXA stem, number of scans, exposure parameters, scan speed and
scan size. Most of these parameters cannot be controlled by
Children and adult doses from DXA have been reported in the operator performing the DXA examination. Table 1 pre-
several studies [24-28]. The increased field size of fan-beam sents the effective dose from spine radiographs, while Ta-
scanners (linear-array detector) and more recently of cone ble 2 delineates doses associated with different diagnostic
beam densitometers (bi-dimensional detector), compared X-ray examinations as derived from the literature. Table 3
to pencil beam devices, has resulted in shorter scan times shows doses from PA spine, proximal femur and total body
allowing greater patient compliance and better image qua- DXA scans [26, 30, 31].
lity. However, patient doses associated with state-of-the-art Children may require densitometry to assess and moni-
DXA scanners have also been increased [29]. tor BMD for chronic diseases (e.g. endocrine disorders) or
Patient doses from pencil-beam DXA is 1 μSv or less. pharmacological treatments (e.g. chemotherapy). The use of
This dose level is lower than the average daily dose from na- an adult standardised scan protocol in imaging of paediatric
tural background radiation. Patient doses up to 15 μSv and patients is a common cause for excessive radiation to these
10 μSv for spine and hip scans, respectively, have been re- patients. This may be attributed to the fact that the exposure
ported for fan-beam DXA examinations performed on adult parameters and the image size selected in these protocols
patients [26]. For paediatric patients doses are higher and are optimised for standard-sized adults. Specifically, pae-
can exceed 50 μSv if adult acquisition protocols are used diatric patients will receive about two to three times higher
[26]. ED than adults due to (a) the larger field size and (b) higher
There are many variables affecting patient dose from dose to internal organs because of less attenuation of X-rays
DXA, such as the site of measurement (e.g. lumbar spine, by overlying tissue [26]. DXA systems require different
forearm, hip and total body), patient body size, acquisition software for paediatrics, for both scanning adjustments and
Radiol med (2012) 117:1347–1354 1351

Table 3 Adult effective doses for examinations performed on Hologic Discovery/QDR4500 DXA devices (from Blake et al. [26], with permission)

Tabella 3 Dosi effettive nei soggetti adulti per esami eseguiti su scanner DXA Hologic Discovery/QDR4500 (da Blake et al. [26], con autorizzazione)

Examinations Scan modes Effective dose


(μSv)

ICRP 60 ICRP 103

PA spine Array 13.3 N/A


Fast 6.7 N/A
Express 4.4 4.4

Hip Array 9.3 N/A


Fast 4.7 N/A
Express 3.1 2.4

Whole body 4.2/8.4 N/A


(Discovery-A/ Discovery-W)

PA, posterior-anterior; N/A, not available

appropriate database comparison. A lumbar spine or total and 125 mAs tube load delivers a radiation dose to a patient
body scan generally provides sufficient information about from 60 to approximately 300 μSv, depending on protocol
the bone status in children. Additional skeletal sites should parameters and CT scanner model [25, 33]. Recently, 3D
be scanned only when the radiation dose is justified by the QCT protocols have been developed based on multidetector
potential clinical benefit. CT (MDCT) imaging, providing accurate measurements of
Bone densitometry is rarely necessary in a pregnant pa- BMD and new insights into bone geometry. However, QCT
tient. BMD measurements may help to diagnose pregnancy- examinations using MDCT are associated with high radia-
associated osteoporosis and exclude the presence of patho- tion doses (1.5 mSv and 2.9 mSv for the spine and the hip
logy with characteristics similar to those of osteoporosis. 3D scans, respectively) [34, 35]. On the other hand, QCT of
Damilakis et al. estimated conceptus doses and risks related the appendicular skeleton, is associated with low patient ED
to DXA acquisitions performed during pregnancy [32]. To (lower than 10 μSv) [34].
minimise the number of accidental exposures of pregnant The analysis of MDCT high resolution (HR) images
patients from DXA careful screening for pregnancy is nee- provides important information about the trabecular bone
ded. When a patient is found to be pregnant after having network [36, 37]. However, patient doses associated with
undergone a DXA examination, communication with the HRCT (with isotropic spatial resolution, submillimetre ran-
woman is very important to give her an assessment of con- ge) are high , reaching about 3 mSv [38].
ceptus dose. Published research shows that conceptus doses Several factors play a role in the reduction of radiation
and potential radiogenic risks from DXA are negligible and, dose to the patient. The use of newly developed reconstruc-
therefore, abortion due to radiation exposure is not recom- tion algorithms can decrease image noise, providing better
mended [22, 32]. image quality at lower radiation burden. Proper selection of
In the case of serial DXA scans, as in follow-up studies, protocol settings, including the selection of minimal scan
the radiation burden is increased. Justification of these exa- length, is very important to limit the dose. The use of adap-
minations should be performed with special care to ensure tive section collimation, available in new-generation MDCT
that the expected benefits exceed the potential risks. scanners, allows reduction of exposure due to z-over scan-
ning associated with helical scanning [39]. Moreover, ul-
QCT trathin (i.e., 1.2 and 2 mm) beam collimations should not be
used unless strictly necessary for specific clinical purpose,
Assessment of BMD is possible using CT scanners. This due to their contribution to dose increase. Optimising the
method allows a separate assessment of cortical and tra- X-ray beam spectrum or activating the automatic exposu-
becular BMD, expressed in mg/cm3. A typical single-slice re control system of the CT scanner is also helpful in de-
2D spine QCT protocol consists of a scout image and th- creasing the radiation dose. Nevertheless, studies are still
ree slices in the midplane of vertebral bodies between T12 needed to maximise the diagnostic information provided by
and L3. An examination acquired at 80 kVp tube potential the new technologies with the lowest radiation dose to the
1352 Radiol med (2012) 117:1347–1354

patient. The use of CTDI to ED conversion coefficients may dical radiation physicists to assess shielding requirements
provide an estimate of patient exposure on modern MDCT associated with DXA. If the room configuration does not
scanners [40, 41]. However, more accurate calculation of provide the necessary distance between DXA and operator,
patient ED is possible using patient-specific Monte Carlo a transparent lead-acrylic shielding may be required to pro-
software packages for CT dosimetry [42]. tect healthcare personnel while viewing the patient during
Peripheral QCT (pQCT) scanners are dedicated units ca- the examination.
pable of assessing bone architecture and BMD at appendi-
cular bones. Using a recently developed HR pQCT scanner,
in vivo images have been obtained with an isotropic spatial Preventive maintenance procedures
resolution of 82 μm [43]. The ED from pQCT examinations
is on the order of few μSv [34, 43]. In addition to QC and dose measurements, a periodic as-
sessment of the condition of the bone densitometry device
is of primary importance (i.e. checking of electrical safety,
Occupational radiation doses and shielding equipment emergency stop, radiation warning lights, the
availability and adequacy of patient support tools). Moreo-
The scan type and mode, the workload and the relative po- ver all resulting test results should be recorded and periodi-
sition of the workstation to the scanning table are factors cally reviewed to detect needed changes [9].
influencing exposure to the operator. The ICRP recommen-
ds that the ED to a radiation worker should be limited to 20
mSv per year [22]. Education and staff training
The radiation exposure of DXA operators is usually very
low, when all procedures are performed following the gui- The performance of a bone densitometry facility is greatly
delines. The Ministry of Health Service in British Columbia influenced by the education and training of the staff deli-
has found that the exposure per 1000 scans to the bone den- vering the services. Radiologists should be fully trained in
sitometry operator was 56.0 mR for Hologic QDR4500W, pathophysiology, treatment of osteoporosis and bone me-
7.0 mR for Norland Eclipse XE and 21.0 mR for GE Pro- tabolic diseases. They should also be acquainted with the
digy Lunar [44]. In a more recent study, Larkin et al. [27] application of all radiological techniques employed for the
found that the annual effective dose from fan-beam systems diagnosis of osteoporosis and familiar with the bone densi-
at a distance of 1 m ranges from 0.5 to 1.5 mSv, depending tometry diagnostic activity [45]. Medical physicists should
on the DXA model. have competency and knowledge of QC and dosimetry
An increase in the operator’s distance from the patient techniques in bone densitometry to minimise exposure of
and the use of mobile or immobile shielding can reduce the patients and optimise examinations [46]. The American
operator’s ED [27]. The need for shielding mainly depends Society of Radiologic Technologists recently released the
on patient workload, the size of the examination room, and Bone Densitometry Curriculum to provide guidelines on
the type of DXA scanner (especially for fan-beam techno- the standards for the training of technologists dealing with
logy). Generally, no additional shielding is required in the bone densitometry. Continuing medical education is of gre-
walls of a properly designed DXA facility [9]. When plan- at importance for all medical professionals involved in bone
ning a bone densitometry facility, however, several para- densitometry to ensure that knowledge and skills are up to
meters should be taken into account so that the exposure date. Several national and international societies such as the
in adjoining areas is at a level acceptable for members of International Society for Clinical Densitometry provide trai-
the public. A shielding study should be performed by me- ning courses for both physicians and technologists [47].

Conflict of interest None

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