The Impact of Radiation Energy on Dose Homogeneity and Organ Dose in the Göttingen Minipig Total-Body Irradiation Model.

Animal models of total-body irradiation (TBI) are used to elucidate normal tissue damage and evaluate the efficacy of medical countermeasures (MCM). The accuracy of these TBI models depends on the reproducibility of the radiation dose-response relationship for lethality, which in turn is highly dependent on robust radiation physics and dosimetry. However, the precise levels of radiation each organ absorbs can change dramatically when different photon beam qualities are used, due to the interplay between their penetration and the natural variation of animal sizes and geometries. In this study, we evaluate the effect of varying the radiation energy, namely cobalt-60 (Co-60); of similar penetration to a 4-MV polyenergetic beam), 6 MV and 15 MV, in the absorbed dose delivered by TBI to individual organs of eight Göttingen minipigs of varying weights (10.3-24.1 kg) and dimensions (17.5-25 cm width). The main organs, i.e. heart, lungs, esophagus, stomach, bowels, liver, kidneys and bladder, were contoured by an experienced radiation oncologist, and the volumetric radiation dose distribution was calculated using a commercial treatment planning system commissioned and validated for Co-60, 6-MV and 15-MV teletherapy units. The dose is normalized to the intended prescription at midline in the abdomen. For each animal and each energy, the body and organ dose volume histograms (DVHs) were computed. The results show that more penetrating photon energies produce dose distributions that are systematically and consistently more homogeneous and more uniform, both within individual organs and between different organs, across all animals. Thoracic organs (lungs, heart) received higher dose than prescribed while pelvic organs (bowel, bladder) received less dose than prescribed, due to smaller and wider separations, respectively. While these trends were slightly more pronounced in the smallest animals (10.3 kg, 19 cm abdominal width) and largest animals (>20 kg, ∼25 cm abdominal width), they were observed in all animals, including those in the 9-15 kg range typically used in MCM models. Some organs received an average absorbed dose representing <80% of prescribed dose when Co-60 was used, whereas all organs received average doses of >87% and >93% when 6 and 15 MV were used, respectively. Similarly, average dose to the thoracic organs reached as high as 125% of the intended dose with Co-60, compared to 115% for 15 MV. These results indicate that Co-60 consistently produces less uniform dose distributions in the Göttingen minipig compared to 6 and 15 MV. Moreover, heterogeneity of dose distributions for Co-60 is accentuated by anatomical and geometrical variations across various animals, leading to different absorbed dose delivered to organs for different animals. This difference in absorbed radiation organ doses, likely caused by the lower penetration of Co-60 and 6 MV compared to 15 MV, could potentially lead to different biological outcomes. While the link between the dose distribution and variation of biological outcome in the Göttingen minipig has never been explicitly studied, more pronounced dose heterogeneity within and between organs treated with Co-60 teletherapy units represents an additional confounding factor which can be easily mitigated by using a more penetrating energy.

Dosimetric and bremsstrahlung performance of a single convergent beam for teletherapy device.

The present work investigates preliminary feasibility and characteristics of a new type of radiation therapy modality based on a single convergent beam of photons. The proposal consists of the design of a device capable of generating convergent X-ray beams useful for radiotherapy. The main goal is to achieve high concentrated dose delivery. The first step is an analytical approach in order to characterize the dosimetric performance of the hypothetical convergent photon beam. Then, the validated FLUKA Monte Carlo main code is used to perform complete radiation transport to account also for scattering effects. The proposed method for producing convergent X-rays is mainly based on the bremsstrahlung effect. Hence the operating principle of the proposed device is described in terms of bremsstrahlung production. The work is mainly devoted characterizing the effect on the bremsstrahlung yield due to accessories present in the device, like anode material and geometry, filtration and collimation systems among others. The results obtained for in-depth dose distributions, by means of analytical and stochastic approaches, confirm the presence of a high dose concentration around the irradiated target, as expected. Moreover, it is shown how this spot of high dose concentration depends upon the relevant physical properties of the produced convergent photon beam. In summary, the proposed design for producing single convergent X-rays attained satisfactory performance for achieving high dose concentration around small targets depending on beam spot size that may be used for some applications in radiotherapy, like radiosurgery.

Assessment of national dosimetry quality audits results for teletherapy machines from 1989 to 2015.

The purpose of this study was to ensure accuracy in radiation dose delivery, external dosimetry quality audit has an equal importance with routine dosimetry performed at clinics. To do so, dosimetry quality audit was organized by the Secondary Standard Dosimetry Laboratory (SSDL) of Pakistan Institute of Nuclear Science and Technology (PINSTECH) at the national level to investigate and minimize uncertainties involved in the measurement of absorbed dose, and to improve the accuracy of dose measurement at different radiotherapy hospitals. A total of 181 dosimetry quality audits (i.e., 102 of Co-60 and 79 of linear accelerators) for teletherapy units installed at 22 different sites were performed from 1989 to 2015. The percent deviation between users' calculated/stated dose and evaluated dose (in the result of on-site dosimetry visits) were calculated and the results were analyzed with respect to the limits of ± 2.5% (ICRU "optimal model") ± 3.0% (IAEA on-site dosimetry visits limit) and ± 5.0% (ICRU minimal or "lowest acceptable" model). The results showed that out of 181 total on-site dosimetry visits, 20.44%, 16.02%, and 4.42% were out of acceptable limits of ± 2.5% ± 3.0%, and ± 5.0%, respectively. The importance of a proper ongoing quality assurance program, recommendations of the followed protocols, and properly calibrated thermometers, pressure gauges, and humidity meters at radiotherapy hospitals are essential in maintaining consistency and uniformity of absorbed dose measurements for precision in dose delivery.

Assessment of dose error due to nylon mesh of treatment couch.

PURPOSE: This study aims at the assessment of dose error in patients undergoing radiotherapy due to treatment couch of Co-60 teletherapy unit. MATERIALS AND METHODS: In this study beam attenuation due to treatment couch of Co-60 unit was measured in air for different gantry angles and field sizes. Polymethylmethacrylate (PMMA) phantom was used to estimate the effect of depth on attenuation. Impact of couch on surface dose was also evaluated. RESULTS: Beam attenuation due to couch was in the range of 0.5-28% for different gantry angles with standard field size of 10 × 10 cm(2) with optimum position of metallic cranks. Maximum attenuation (29%) was observed with smallest field size i.e. 5 × 5 cm(2). Beam attenuation has been found higher in phantom as compared to that in air However, no particular trend of attenuation has been noted with varying depth of phantom. A 6% increase in surface dose has also been observed due to couch insertion for normal beam incidence. Maximum error of 80% is also note-worthy for most unfavorable situation of irradiation at 180 degree through the metallic cranks. CONCLUSION: It has been determined that ignoring the treatment couch and its accessories can result in dose error of 0.5-80%, depending on gantry angle, field size and position of couch accessories. Therefore, consideration of dose error due to couch during treatment planning is recommended.

Physical characterization of single convergent beam device for teletherapy: theoretical and Monte Carlo approach.

The main purpose of this work is to determine the feasibility and physical characteristics of a new teletherapy device of radiation therapy based on the application of a convergent x-ray beam of energies like those used in radiotherapy providing highly concentrated dose delivery to the target. We have denominated it Convergent Beam Radio Therapy (CBRT). Analytical methods are developed first in order to determine the dosimetry characteristic of an ideal convergent photon beam in a hypothetical water phantom. Then, using the PENELOPE Monte Carlo code, a similar convergent beam that is applied to the water phantom is compared with that of the analytical method. The CBRT device (Converay(®)) is designed to adapt to the head of LINACs. The converging beam photon effect is achieved thanks to the perpendicular impact of LINAC electrons on a large thin spherical cap target where Bremsstrahlung is generated (high-energy x-rays). This way, the electrons impact upon various points of the cap (CBRT condition), aimed at the focal point. With the X radiation (Bremsstrahlung) directed forward, a system of movable collimators emits many beams from the output that make a virtually definitive convergent beam. Other Monte Carlo simulations are performed using realistic conditions. The simulations are performed for a thin target in the shape of a large, thin, spherical cap, with an r radius of around 10-30 cm and a curvature radius of approximately 70 to 100 cm, and a cubed water phantom centered in the focal point of the cap. All the interaction mechanisms of the Bremsstrahlung radiation with the phantom are taken into consideration for different energies and cap thicknesses. Also, the magnitudes of the electric and/or magnetic fields, which are necessary to divert clinical-use electron beams (0.1 to 20 MeV), are determined using electromagnetism equations with relativistic corrections. This way the above-mentioned beam is manipulated and guided for its perpendicular impact upon the spherical cap. The first results that were achieved show in-depth dose peaks, having shapes qualitatively similar to those from hadrontherapy techniques. The obtained results demonstrate that in-depth dose peaks are generated at the focus point or isocenter. These results are consistent with those obtained with Monte Carlo codes. The peak-focus is independent of the energy of the photon beam, though its intensity is not. The realistic results achieved with the Monte Carlo code show that the Bremsstrahlung generated on the thin cap is mainly directed towards the focus point. The aperture angle at each impact point depends primarily on the energy beam, the atomic number Z and the thickness of the target. There is also a poly-collimator coaxial to the cap or ring with many holes, permitting a clean convergent-exit x-ray beam with a dose distribution that is similar to the ideal case. The electric and magnetic fields needed to control the deflection of the electron beams in the CBRT geometry are highly feasible using specially designed electric and/or magnetic devices that, respectively, have voltage and current values that are technically achievable. However, it was found that magnetic devices represent a more suitable option for electron beam control, especially at high energies. The main conclusion is that the development of such a device is feasible. Due to its features, this technology might be considered a powerful new tool for external radiotherapy with photons.

Secondary radiation dose during high-energy total body irradiation.

AIM: The goal of this work was to assess the additional dose from secondary neutrons and γ-rays generated during total body irradiation (TBI) using a medical linac X-ray beam. BACKGROUND: Nuclear reactions that occur in the accelerator construction during emission of high-energy beams in teleradiotherapy are the source of secondary radiation. Induced activity is dependent on the half-lives of the generated radionuclides, whereas neutron flux accompanies the treatment process only. MATERIALS AND METHODS: The TBI procedure using a 18 MV beam (Clinac 2100) was considered. Lateral and anterior-posterior/posterior-anterior fractions were investigated during delivery of 2 Gy of therapeutic dose. Neutron and photon flux densities were measured using neutron activation analysis (NAA) and semiconductor spectrometry. The secondary dose was estimated applying the fluence-to-dose conversion coefficients. RESULTS: The main contribution to the secondary dose is associated with fast neutrons. The main sources of γ-radiation are the following: (56)Mn in the stainless steel and (187)W of the collimation system as well as positron emitters, activated via (n,γ) and (γ,n) processes, respectively. In addition to 12 Gy of therapeutic dose, the patient could receive 57.43 mSv in the studied conditions, including 4.63 µSv from activated radionuclides. CONCLUSION: Neutron dose is mainly influenced by the time of beam emission. However, it is moderated by long source-surface distances (SSD) and application of plexiglass plates covering the patient body during treatment. Secondary radiation gives the whole body a dose, which should be taken into consideration especially when one fraction of irradiation does not cover the whole body at once.

Dose measurement of cobalt-60 radiotherapy beams in treatment fields.

BACKGROUND: Radiation-therapy is a complex process with multiple steps, each of which has an impact on the quality of treatment. Accurate dosimetry is a critical step during the radiotherapy of cancer patients.The aim of the present study was to measure and evaluate the doses of two cobalt- 60 (60Co) teletherapy units GWXJ80 of NPIC China and Theratron 780 of AECL Canada at various points within fields for different field sizes. METHODS: This cross-sectional descriptive study was done to measure the 60Co doses in the treatment fields.The dose measurements were done in air and 30x30x30 cm3 Phantom at 80 cm SSD by using calibrated NE 2570 Farmer Electrometer & NE 2571 Farmer Ionization Chamber and percentage of doses were calculated. RESULTS: The results showed that 60% central area of all fields ranging from 100-98.79% and 100-96.12% for GWXJ80 in the air and phantom, whereas for Theratron 780, they were ranging from 100-98.50% and 100-96.45% in air and phantom respectively. The percentages of doses at the edges for GWXJ80 and Theratron 780 in the air were 75.39-38.66% & 85.65-46.47% respectively and they were 82.22-40.39% & 49.05-24.55% respectively in phantom. CONCLUSIONS: The doses within 60% central area of fields in air were higher than phantom for both teletherapy units. The doses at field edges in air were lower in GWXJ80 than Theratron 780 whereas in phantom they were vice versa. But all were in the acceptable range as recommended by International Commission on Radiation Units and Measurements.

Aperture superposition dose model versus pencil beam superposition dose model for a finite size Cobalt-60 source for tomotherapy deliveries.

PURPOSE: The finite size pencil beam (FSPB) superposition method is a commonly used dose calculation method in intensity modulated radiation therapy (IMRT). The FSPB model assumes that dose for a broad intensity modulated beam can be calculated by superposition of dose from small, pencil-like beams. However, this model is limited to point-like radiation sources and is not valid for finite size sources, such as a Cobalt-60 (Co-60) source of 2 cm diameter. In this paper, the authors present results that show the limitation of this model and propose an alternative model, namely the aperture superposition (AS) model, to calculate photon dose for intensity modulated beams arising from finite size radiation sources. METHODS: The AS model is based on adding beam apertures rather than pencil beams. Each aperture is defined as a series of adjacently opened leaves of a multileaf collimator with no closed leaves in between them. The apertures are calculated using the EGSnrc Monte Carlo program. The accuracy of the AS model was tested for dose calculations of fan beams, as encountered in tomotherapy treatment plans. The results were compared with the FSPB model and GafChromic film measurements. The measurements and simulations were performed for a clinical Theratronics T780C Co-60 unit with MIMiC binary multileaf collimator mounted on it. RESULTS: The comparisons between the AS model and film measurements show agreement better than 1.5% in the high dose regions and 3.7% in the low dose regions. On the contrary, film measurement comparisons to the FSPB model show that the FSPB model underestimates the dose by up to 7% for small field sizes such as 2 × 2 cm(2) and 20% for larger field sizes such as 20 × 2 cm(2). CONCLUSIONS: The results presented in this paper indicate that the AS model provides better accuracy than the FSPB model when calculating dose for fan beams from large radiation sources. The implementation of this model to the current treatment planning systems has the scope of advancing Co-60 based IMRT and tomotherapy.

On the transit dose from motorized wedge treatment in Equinox-80 telecobalt unit.

PURPOSE: To estimate the transit dose from motorized wedge (MW) treatment in Equinox-80 telecobalt machine. MATERIALS AND METHODS: Two plans were generated in Eclipse treatment planning system with universal wedge (UW) and MW each for 10 x 10 cm 2 . The transit dose was measured with 0.6 cc cylindrical ion chamber and thermoluminescent dosimeters (TLD) chips at a depth of 5 cm with source to axis distance (SAD) 80 cm. RESULTS: The measured dose with ion chamber was in well agreement with the calculated dose from Eclipse within +/- 2%. The planned dose was 100 cGy while the measured absorbed dose with ion chamber for 15 degrees , 30 degrees , 45 degrees and 60 degrees MW treatment was found to be 100.94, 101.04, 100.72 and 99.33 cGy respectively. For 15 degrees , 30 degrees , 45 degrees and 60 degrees UW treatment, the measured absorbed dose was 99.33, 97.67, 97.77 and 99.57 cGy respectively. Similarly the measured absorbed dose with TLD was within +/- 3% with the planned dose for universal wedge (UW) and MW. From the experimental measurements, it was found that there was no significant contribution of transit dose during MW treatment. CONCLUSION: The actual measurements carried out with ion chamber in Equinox-80 machine for UW and MW revealed no variation between the doses delivered. The doses were comparable for both UW and MW treatments. The results from TLD measurements additionally confirmed no variation between the doses delivered with UW and MW. It was also demonstrated that the observed excess or less transit dose with MW does not have any significant clinical impact. This assured the safe dose delivery with MW.

Adaptation of telecobalt unit for stereotactic irradiation.

We investigated the feasibility of using an isocentric telecobalt unit for advanced treatment techniques, such as stereotactic radiotherapy. To adapt the telecobalt unit (Th780 C) for stereotactic irradiation, collimator inserts of various sizes, collimator mount, and a couch mount suitable for the telecobalt unit were developed, and the characteristics of the narrow beams of Cobalt-60 (60Co) were studied. Comparative study was carried out between the stereotactic radiotherapy plans of 6 MV and 60Co beams using a 3-dimensional (3D) treatment planning system. The beam penumbra of 60Co beams was found to be larger than those of 6 MV beams. The dose-volume histograms (DVH) obtained from the 60Co beam plan were comparable to those obtained from the 6 MV plan. The DVH of nontarget tissue obtained from the plans of the 2 beams were found to be in good agreement to each other. The difference in equivalent fall-off distance (EFOD) for all 3 cases was found insignificant; hence, it can be concluded that the fall-off dose in the dose distribution of the 60Co stereotactic plan is as good as that of the 6 MV stereotactic plan. In all 3 cases for which the treatment plans were compared between 60Co and 6 MV beams, it was observed that the fall-off doses outside the target were similar; therefore, considering 60Co with 5-mm margin is a cost effective alternative for the linac-based stereotactic radiotherapy.

Total body irradiation with a reconditioned cobalt teletherapy unit.

While the current trend in radiotherapy is to replace cobalt teletherapy units with more versatile and technologically advanced linear accelerators, there remain some useful applications for older cobalt units. The expansion of our radiotherapy department involved the decommissioning of an isocentric cobalt teletherapy unit and the replacement of a column-mounted 4-MV LINAC that has been used for total body irradiation (TBI). To continue offering TBI treatments, we converted the decommissioned cobalt unit into a dedicated fixed-field total body irradiator and installed it in an existing medium-energy LINAC bunker. This article describes the logistical and dosimetric aspects of bringing a reconditioned cobalt teletherapy unit into clinical service as a total body irradiator.

Quality control system for blood irradiation using a teletherapy unit.

BACKGROUND AND OBJECTIVES: Irradiation of whole blood and blood components before transfusion is currently the only accepted methodology to prevent transfusion-associated graft-vs.-host disease. In the present work, we developed an automated system for blood bag storage during irradiation, using a teletherapy unit. MATERIALS AND METHODS: A device with two thermal compartments was constructed in acrylic and foam, for the storage of blood bags during irradiation. An automatic acquisition system, coupled with an amplifier and a thermal-sensitive probe, were developed to check blood temperature during irradiation. A polystyrene phantom was constructed to simulate the volume of blood routinely irradiated. The dose distribution was measured in the phantom using thermoluminescent dosimeters and represented in terms of isodose curves. RESULTS: The thermal device kept the blood temperature below 6 degrees C for more than 2 h. Our system allowed the simultaneous irradiation of two different blood components while maintaining a constant temperature. The temperature monitoring system remained invariant (0.2 degrees C) over the whole irradiation interval. Phantom dosimetric results showed a homogeneous dose distribution when the phantom was irradiated, using rotational fields with a 2 r.p.m. frequency. CONCLUSIONS: The methodology developed in the present work provides appropriate storage conditions during irradiation of both red blood cells and platelet blood components using a teletherapy unit.

Decommissioning of a 60Co unit and estimation of personal doses.

Chang-hua Christian Hospital needs to uninstall the 60Co unit. The mode of this 60Co teletherapy unit is SHIMADZU RTGS-10. The original lead head was taken as the source container of this 60Co unit. The source head was dismantled and put into the prepared wooden box, after the source was sealed. This study describes the planning and dismantling of the retirement and transport of the 60Co unit, and personal doses measured during the procedure. This work estimates the doses of radiation received by exposed workers during the dismantling of the machine. The workers received doses of approximately 53 microSv. This study shows that the original lead head can be used as the source container of this 60Co unit. The 60Co machine was smoothly dismantled and transported by conscientious and careful workers, using planned and controlled radiation protection, following the ALARA (as low as reasonably achievable) rule.

Using a tungsten rollbar to characterize the source spot of a megavoltage bremsstrahlung linac.

In photon teletherapy, the size and functional form of the photon source spot affect both the sharpness of the penumbra of treatment fields and the sharpness of portal images. Photon source spot parameters are also used in photon teletherapy dose calculation codes. A simple method for characterizing the source spot would complement the existing, more involved methods that have been described in the medical physics literature. Such a method, using a rollbar made of tungsten or other high-Z metal, is used in industrial radiography. We describe the use of a tungsten rollbar for characterizing the source spot edge spread function (and thereby the source spot size and shape) of a megavoltage bremsstrahlung photon source. We use Monte Carlo simulations to quantify anticipated experimental artifacts of the method, assuming typical spot sizes for circ-function, Gaussian, and Bennett line shapes. We illustrate the use of the rollbar method by characterizing the source spot of a typical 9 MV linac used for industrial radiography. The source spot is analyzed using two approaches: (a) fitting the rollbar image with analytic functions and (b) using Abel inversion to obtain the cylindrically symmetric spot profile consistent with the measured rollbar image. Monte Carlo simulations, based on a 6 MV photon teletherapy accelerator, suggest that aspects of the method are applicable to medical bremsstrahlung sources.

Radiotherapy services in countries in transition: gross national income per capita as a significant factor.

BACKGROUND AND PURPOSE: The acquisition of radiotherapy by countries in transition (CITs) is an evolutionary process from having no resources whatsoever, to meeting the standards adopted by well-developed countries. The influence of the economic ability of a country to acquire and sustain this technology has intuitively been accepted as a major factor but has not before been subjected to analysis for a large group of countries. This information has been analysed to provide guidance to countries commencing and expanding radiotherapy services. MATERIAL AND METHODS: The number of linear accelerators and (60)Co megavoltage teletherapy machines in 72 CITs, those with gross national income per capita (GNI/cap)<$12000 per annum (pa) and a sample of 12 countries with GNI/cap>$12000 pa were expressed as machines per million population (MEV/mil) and used as an index of the ability of the country to provide a service. This figure was related to GNI/cap. The average populations of 24 further countries without radiotherapy were compared with 21 countries with radiotherapy facilities having the same range of GNI/cap. RESULTS: The relationship log(10) MEV/mil=-2.90+0.85 log(10) GNI/cap was identified between the machines and income. Also verified was that small low income countries were less likely to have the technology than those with large populations. CONCLUSIONS: The increase in the number of teletherapy machines is closely linked to the GNI/cap of a country. Our sample of well developed countries failed to demonstrate a levelling off of equipment acquisition with income. In the lower income group, smaller countries were less likely to have radiotherapy services than those with large populations.

[Accidents in radiotherapy: historical account]. / Accidents en radiothérapie: un historique.

Radiotherapy accidents are exceedingly rare. However, they may have major negative consequences: for health (and sometimes life) of victims as well as for the trust that patients put in radiotherapy and radiation oncologists. Each accident must be pointed out, analysed and reported, in order to allow preventive actions, avoiding repetitive accidents. Through examples of majors accidents occurred all over the world in the last decades, affecting professionals, public or patients themselves, the necessity of transparency is demonstrated. The International Commission of Radiobiological Protection has drawn positive lessons from such accidents and insists on following recommendations: necessity of sufficient number and competent professionals, importance of continuous and initial education, information of professionals and, in general, a strict Quality Assurance program. It is clear that each radiotherapy center remains at risk for errors. It is essential to develop preventive procedures to avoid transformation of errors into accidents. In that context, complete and detailed description and reports of each anomaly or incident must be encouraged as it is done for sectors of aviation or nuclear industry. Radiation oncology must develop such a culture of transparency and of systematic report of all incidents.

Lesson learned from Co-60 accident in Thailand.

The causes and consequences of a Co-60 radiation accident in Samutprakarn Province, Thailand, were scrutinized to learn lessons aimed at preventing future radiation accidents. "Orphan sources" may end up in scrapyards. An out-of-use Co-60 medical teletherapy source, left unattended in a disused parking area belonging to a Medical Dealer, was stolen and sold to a scrap dealer in Samutprakarn Province at the end of January 2000. Because of its valuable appearance, a number of workers in the scrap trade who were not aware of radiation hazards managed to dismantle all parts. The Co-60 source was removed and left unshielded among pieces of scrap metal in the yard of the scrap shop. Some workers immediately became sick. Eighteen days later when they went to a local hospital their symptoms were recognized as radiation sickness and the incident was reported to the Office of Atomic Energy for Peace (OAEP) in Thailand. The unshielded source, with an estimated activity of 15.7 TBq (425 Ci), was retrieved soon after by an emergency team and placed in safe storage at the OAEP premises. Ten victims developed radiation sickness symptoms, of which three died soon after the accident. The accident alarmed the public, and has raised national concerns. The accident is similar in some ways to the 1987 radiation accident at Goiania, Brazil, involving a Cs-137 radiotherapy source. If not properly disposed of orphan radiation sources can lead to serious injury or even death. The accident highlights the need for security of spent high activity sources and the importance of regulatory controls.