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Published online before print March 28, 2006, 10.1148/radiol.2392050504
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(Radiology 2006;239:541-546.)
© RSNA, 2006

Technical Developments

Radiosensitive Functional Dye: Clinical Application for Estimation of Patient Skin Dose1

Shigeru Suzuki, MD, Shigeru Furui, MD, Hiroshi Kohtake, MD, Tohru Takeshita, MD, Masatoshi Suzuki, MD, Ken Kozuma, MD, Yoshito Yamamoto, MD and Takaaki Isshiki, MD

1 From the Departments of Radiology (S.S., S.F., H.K., T.T.) and Medicine (M.S., K.K., Y.Y., T.I.), Teikyo University School of Medicine, 2-11-1 Kaga, Itabashi-ku, Tokyo 173-8605, Japan. Received March 26, 2005; revision requested May 25; revision received June 11; final version accepted July 1. Supported in part by Health and Labour Sciences Research Grants for Research on Pharmaceutical and Medical Safety from the Ministry of Health, Labour and Welfare, Tokyo, Japan. Address correspondence to S.S. (e-mail: s-suzuki{at}med.teikyo-u.ac.jp).


   ABSTRACT
TOP
 ABSTRACT
INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 
Institutional review board approval and informed patient consent were obtained. The purpose of the study was to prospectively evaluate the use of radiosensitive indicators to estimate patient entrance skin dose (ESD). Forty-six patients wore a jacket with 48 or 52 indicators adhered to the back during percutaneous coronary interventions; they had eight additional indicators on their upper arms. The patients' ESDs were calculated according to the change in color of the indicators. There were good correlations between the ESDs estimated by using color measurements performed with an optical instrument and those estimated at visual observation (P < .001) and between the ESDs estimated by using a thermoluminescent dosimeter and those estimated by using color measurements (P < .001). The radiosensitive indicator method seems to be useful for estimating ESDs and their distribution during percutaneous coronary intervention; however, visual observation is reliable for estimating doses of up to 5 Gy only.

© RSNA, 2006


   INTRODUCTION
TOP
 ABSTRACT
 INTRODUCTION
MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 
Interventional radiology procedures are characterized by low invasiveness. The use of these procedures has recently spread quickly and enabled the successful treatment of various conditions. However, with the spreading use of interventional radiology procedures, radiation-induced skin injuries (eg, ulcer, psilosis, etc) in patients have been reported (1–6). Therefore, estimation of the radiation dose delivered to the skin of patients during interventional radiologic procedures and prevention of radiation skin injuries are important.

The Food and Drug Administration recommends recording the unambiguous identification of areas on the patient's skin that have received an absorbed dose (during an interventional radiology procedure) that approaches or exceeds the threshold for radiation skin injuries (7,8)—specifically erythema at 2 Gy, temporary epilation at 3 Gy, permanent epilation at 7 Gy, and dermal necrosis at 18 Gy (1,8). However, the optimal method of archiving this exposure has not yet been established, although some methods of estimating the skin dose are available.

Radiosensitive indicators function on the basis of the properties of a functional dye that changes in color, from colorless to red, with x-ray absorption. The radiation dose delivered to a wide area can be estimated by placing multiple indicators on a patient's skin. Thus, the purpose of our study was to prospectively evaluate the use of radiosensitive indicators to estimate the patient entrance skin dose (ESD).


   MATERIALS AND METHODS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
RESULTS
 DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 
Patients
Our study included 46 patients (nine women, 37 men) from a group of 135 patients who underwent nonemergent percutaneous coronary interventions (PCIs) from July to December 2004. The mean patient age was 70.7 years ± 8.0 (standard deviation) (range, 54.7–83.6 years). The study was approved by the institutional review board of our hospital, and all patients gave informed consent for participation. Seven cardiologists (including M.S., K.K., and Y.Y.) who had 6–17 years of experience with PCIs performed the interventional procedures by using standard techniques. Twenty-eight procedures were performed to treat one stenotic lesion, 11 were performed to treat multiple stenotic lesions, and seven were performed to treat chronic total occlusion. In our study, seven percutaneous transluminal coronary angioplasty procedures without stent implantation and thirty-nine percutaneous transluminal coronary angioplasty procedures with stent implantation were performed.

Angiography
We used single-plane (AdvantX LC; GE Medical Systems, Milwaukee, Wis) and biplanar (AdvanteX LC/LP; GE Medical Systems) angiographic units. For our research, however, the AdvanteX LC/LP unit was used as a single-plane angiographic system. Both units had been used at our institution for more than 9 years. The image intensifiers on both units were exchanged in April 2004. Each unit had an undercouch tube and an overcouch image intensifier with three fields of view: 9.0, 6.0, and 4.5 inches. The 6.0-inch field of view was used in our assessments. In both units, an additional filter, 0.5-mm aluminum, was used, and the total filtration was equivalent to 2.7-mm aluminum. The pulse mode (pulse rate, 25 pulses per second) was used to perform fluoroscopy. Both units operated with automatic exposure control and in low, medium, and high fluoroscopy modes. We used the medium mode. For cine image acquisition, the frame rate was 25 frames per second.

Indicator Use and Evaluation
Each study patient wore a jacket that had 48 indicators (RadiMap; Nichiyu Giken Kogyo, Saitama, Japan) adhered to the back (Fig 1). Each indicator comprised a square of about 1.5 cm and was applied with an adhesive to the reverse side. The indicators were arranged in six rows (rows 1–6) from top to bottom and eight columns (columns A–H) from left to right, 7 cm apart. In thirty-eight patients, an additional four indicators were placed in the seventh row (indicators C7, D7, E7, and F7). In all patients, four additional indicators were adhered to each upper arm.


Figure 1
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  		Figure 1: Photograph of 52 indicators adhered to a jacket and arranged in seven rows (rows 1–7, from top to bottom) and eight columns (columns A–H, from left to right), 7 cm apart. Eight additional indicators were placed at the acromion, olecranon, and two points trisecting each upper arm (points 1–4, proximal to distal).

 
After the PCI, the colors of the indicators were analyzed with a color-measuring instrument (Chroma Meters CR-300; Konika Minolta Holdings, Tokyo, Japan) and the absorbed doses were calculated on the basis of differences in the color of the indicators. We regarded the absorbed doses as the ESDs at specific points on the jacket. The color difference was defined by using the formulas given in the Appendix. We determined the absorbed dose as follows:

The AdvantX UNV (GE Medical Systems) angiography system was used. Irradiation was performed by using an 80-kVp tube voltage, a 400-mA tube current, and an image intensifier size of 12 inches. The indicators were irradiated on the lower surface of a 20-cm-thick water phantom (Tough Water Phantom WE; Kyoto Kagaku, Kyoto, Japan). Figure 2 illustrates the relationship between indicator color difference and absorbed dose. The indicators were calibrated by using an ionization chamber (Radcal Model 9010; Radcal, Monrovia, Calif). With the indicators, the response was almost linear with the natural logarithm of the dose within 10 Gy. The following regression equation was used to calculate the absorbed dose (D, expressed in grays): D = exp(DE · 0.0537 – 1.6894), where DE is the difference in the color of the indicator. In each patient, we evaluated the ESDs at all 56 or 60 points, the maximal ESD, and the maximal ESD location on the basis of the color measurement results.


Figure 2
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  		Figure 2: Graph illustrates the relationship between the difference in color of the indicator and the absorbed dose. The response was almost linear with the natural logarithm of the dose within 10 Gy. The following regression equation was used: D = exp(DE · 0.0537 – 1.6894), where D is the absorbed dose (in grays) and DE is the difference in color of the indicator.

 
ESDs Evaluated at Visual Observation
The three points on the jacket with the largest color differences after each procedure were evaluated at visual observation. Three radiologists (S.S., H.K., and T.T.), who had 11–17 years of experience, determined the ESDs visually in consensus, without knowledge of the doses determined with color measuring. They compared the indicators with the color samples arranged in order of dose (Fig 3). The ESD was evaluated at visual observation by using an 11-dose (0, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 5.0, 6.0, 7.0, and 10.0 Gy) scale.


Figure 3
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  		Figure 3: Color sample used at visual observation of the indicators.

 
Relationship between Thermoluminescent Dosimeter– and Indicator-estimated ESDs
In all seven patients with chronic total occlusion, we estimated the ESD by placing thermoluminescent dosimeter (TLD) chips (TLD-100; Harshaw Bircon, Solon, Ohio) and indicators simultaneously at 20 points. We used TLD chips, packed in groups of three. The packed TLD chips were placed at five rows (rows 2–6) and four columns (columns C–F) on the jacket. The TLD chips were sent out to be read (to Nagase Landauer, Tokyo, Japan) and calibrated with 137 cesium gamma rays. A TLD system (model 2000B + D; Harshaw Bircon) was used for the readouts. The minimal dose that was detectable with the TLD system was 0.2 mSv. The doses measured by the TLD were calibrated by using the ionization chamber with the following equation: Dabs = D/(CF · CC), where Dabs is the absorbed dose (in grays), D is the dose equivalent in 0.07-mm depth (Hp[0.07], in sieverts) measured by the TLD, CF is a correction factor relevant to the energy response of the TLD, and CC is the coefficient that converts the absorbed dose to Hp(0.07) at an energy level of 137 cesium gamma rays (0.66 MeV). According to the guidelines adopted by the International Commission on Radiological Protection in 1995 (9), the converting coefficient was 1.21. In the above-mentioned experiment performed to evaluate the relationship between the color difference and the absorbed dose, the TLD chips were also irradiated while in contact with the ionization chamber. On the basis of these data, the correction factor was 1.21.

Statistical Analyses
The Pearson correlation test was used to determine the relationship between the ESDs estimated by using color measurements and visual observation and those estimated by using TLD and color measurements. We used computer software (StatView J-5.0 for Macintosh; SAS Institute, Cary, NC) to perform these analyses. P < .05 was considered to represent a statistically significant result.


   RESULTS
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 
For all 46 procedures, the mean total time for fluoroscopy was 22.5 minutes ± 14.8 (standard deviation) (range, 7.1–69.5 minutes) and the mean total number of cine frames was 2712 ± 1794 (range, 917–9315) (Table). The mean maximal ESD for all patients was 2.2 Gy ± 2.0 (range, 0.4–9.7 Gy; median, 1.4 Gy). Of the 46 patients, 36 received ESDs that exceeded 1 Gy and 15 received ESDs that exceeded 2 Gy. None of the patients showed skin injuries at routine follow-up 5–10 months after the PCI procedures.


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  		Patient and Angiographic Data

 
To assess the interprocedural distribution of the ESDs in all 46 procedures, we summarized the points that received the maximal ESD in each procedure (Fig 4). The points with the maximal ESD were scattered among 22 points.


Figure 4
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  		Figure 4: Interprocedural distribution of ESDs at anatomic points in rows 1–7 and columns A–H. L = left arm, R = right arm. +, ++, +++, ++++ = one, two, three, or four patients, respectively, received the maximal ESD at the anatomic point. The points were scattered among 22 points.

 
ESDs Evaluated at Visual Observation
The ESDs estimated by using color measurements correlated with those estimated by using visual observation (r2 = 0.9546, P < .001) (Fig 5). The difference between these values was less than 1 Gy when the color measurement–determined ESD was up to 5 Gy. On the other hand, the difference exceeded 1 Gy at several points when the color measurement–determined ESD was higher than 5 Gy.


Figure 5
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  		Figure 5: Graph illustrates the relationship between ESDs estimated by using color measurements of the indicators and those estimated by using visual observation of the indicators. The following regression equation was used: Dins = Dvis · 1.051 + 0.0026, where Dins is the ESD estimated by using the color-measuring instrument and Dvis is the ESD estimated at visual observation (r2 = 0.9546, P < .001). The difference between the two measurements was less than 1 Gy when the color measurement–determined ESD was up to 5 Gy. However, the difference exceeded 1 Gy at several points when the color measurement–determined ESD was higher than 5 Gy.

 
Relationships between TLD- and Indicator-estimated ESDs
Of the 140 points where we placed packed TLD chips and indicators simultaneously, 27 received ESDs of 0.5 Gy or higher at indicator-based dosimetry. We compared the doses estimated by using the two devices at these 27 points. The ESDs estimated by using TLD chips and those estimated by using color measurements of the indicators correlated (r2 = 0.9679, P < .001) (Fig 6).


Figure 6
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  		Figure 6: Graph illustrates the relationship between ESDs estimated by using TLD chips and those estimated by using color measurements of the indicators. The ESDs estimated by using TLD chips correlated with those estimated by using indicators (r2 = 0.9679, P < .001). The following regression equation was used: DTLD = Dind · 0.7827 – 0.0948, where DTLD is the ESD estimated by using TLD chips and Dind is that estimated by using indicators.

 

   DISCUSSION
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 
The methods currently used for dosimetry during interventional radiology procedures are generally divided into those involving placement of the radiometer on the patient surface (10–13) and those involving the calculation of ESDs with use of a dose-area product meter (14–16). With the radiometer method, the measurable area is generally restricted and one cannot necessarily estimate the dose delivered to the maximally exposed part. PCIs in particular are often performed with angulated views. Thus, the points receiving the maximal ESD vary widely with individual procedures. In our study, for 46 PCIs, the points that received the maximal ESD were scattered among 22 points. Therefore, it is impossible to predict the maximal exposure part beforehand and to place the radiometer on that part. Thus, the maximal ESD will be underestimated with use of conventional dosimetry methods, with which the radiometers are placed at several points that are decided beforehand.

Also, the variety of maximal exposure areas during individual PCIs makes it very difficult to presume the maximal exposure points at dosimetry performed with a dose-area product meter. Furthermore, according to Miller et al (17) and other authors (18), dose-area product meter readings correlated poorly with patients' skin doses. Morrell and Rogers (19) used slow radiographic film to measure ESDs. The ESDs and their distribution can be assessed by using this method. However, the film needs to be processed by using a developer and a fixer after exposure, and doses higher than 1 Gy cannot be estimated with the film.

Of the 46 patients examined in our study, 36 received ESDs that exceeded 1 Gy. In patients who receive such doses, repeated procedures may cause severe skin injury (20). However, it is possible to prevent severe skin injuries by changing the angle of the x-ray tube in subsequent procedures, before the cumulative ESD approaches the threshold dose. When the maximal ESD exceeds 5 Gy, we mark the part that received that dose with a radiopaque catheter and exclude it from the irradiation field at fluoroscopy and image acquisition during subsequent procedures. Other methods of reducing skin doses include limiting the number of acquired images, the fluoroscopy time, and the dose rate; increasing the tube filtration; minimizing the distance between the image intensifier and the patient; maximizing the distance between the x-ray tube and the patient; collimating the radiation field as much as possible; using pulsed fluoroscopy; and storing the last image obtained during fluoroscopy (20,21).

There was comparatively good agreement between the ESDs estimated by using visual observation and those estimated by using color measurements of the indicators. The indicators enable the physician to semiquantitatively determine the ESD and its distribution immediately after the procedure, although the indicators are not visible during the procedure. Immediate semiquantitative identification of the ESD increases the physician's concern about the radiation exposure, and constant feedback regarding the effectiveness of the dose-reduction techniques used is possible with use of this indicator method.

There was a strong positive linear association between the ESDs estimated by using TLD chips and those estimated by using color measurements of the indicators. TLD dosimetry is one of the most widely used methods for evaluating patient ESDs during interventional radiology procedures (10–12). With the TLD method, immediate assessment of the ESD is impossible because the system requires a readout. On the other hand, use of the indicator method facilitates evaluation of the ESD with visual observation, as described earlier.

den Boer et al (22) reported the usefulness of a software-based method for the real-time calculation and display of a skin-dose map and the peak skin dose during coronary angiography and intervention. The system they used automatically measures patients' skin doses with use of the geometric settings of the gantry, an investigation table, the x-ray beam, and an ionization chamber. This method allows calculation of the accumulated skin radiation dose and detection of high-dose areas in real time. However, the system has to be installed in individual angiographic units and can be adapted only for specific equipment. Furthermore, the system is no longer offered for sale with new equipment (23). The indicator system described herein can be used more easily at many institutions, regardless of the kind of equipment they have.

Our study had some limitations. First, it is difficult to measure doses of 5 Gy or higher at visual observation by using this indicator system. Therefore, it is necessary to use another product with a higher measurement range to estimate patients' ESDs during procedures that involve higher ESDs, such as PCIs to treat chronic total occlusion or multiple stenotic lesions. It is desirable to estimate a wide dose range more correctly by simultaneously placing two types of indicators with different dose ranges, because it is not necessarily easy to presume the maximal dose beforehand. Second, the radiation fields may have overlapped in the areas between the indicators and thus possibly led to an underestimation of the ESD. Third, the points that received the maximal ESD varied widely with individual procedures and, unexpectedly, they were widely scattered. In six procedures, the point with the maximal dose existed in the marginal part of the measurable area and the point with the practical maximal dose may not have been included in the measurable area. It is necessary to place indicators more widely when the angle of the x-ray tube is strongly oblique or when the patient is large.

In conclusion, the described method involving the use of radiosensitive indicators seems to be useful for estimating ESDs and their distribution during PCIs, although visual observation is reliable for estimating doses of up to 5 Gy only.


   APPENDIX
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
ADVANCE IN KNOWLEDGE
 References
 
The color space method based on the L-a-b model is currently the most widely used system to express the color of objects. It was standardized in 1976 by the Commission Internationale de l'Éclairage (24). In this color space system, L is the lightness coordinate, a is the red-green coordinate, and b is the yellow-blue coordinate. The difference in color in this color space (DE) is the distance between the color locations and is calculated as follows: DE = [(Dl)2 + (Da)2 + (Db)2]1/2, where Dl is the lightness difference, Da is the red-green difference, and Db is the yellow-blue difference.


   ADVANCE IN KNOWLEDGE
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
References
 


   FOOTNOTES
 

Abbreviations: ESD = entrance skin dose • PCI = percutaneous coronary intervention • TLD = thermoluminescent dosimeter

Author contributions: Guarantor of integrity of entire study, S.S.; study concepts/study design or data acquisition or data analysis/interpretation, all authors; manuscript drafting or manuscript revision for important intellectual content, all authors; manuscript final version approval, all authors; literature research, S.S., S.F., H.K., T.T.; clinical studies, S.S., M.S., K.K., Y.Y., T.I.; experimental studies, S.F., H.K.; statistical analysis, S.S., S.F.; and manuscript editing, S.S., S.F., T.T., M.S., K.K., Y.Y., T.I.

Authors stated no financial relationship to disclose.


   References
TOP
 ABSTRACT
 INTRODUCTION
 MATERIALS AND METHODS
 RESULTS
 DISCUSSION
 APPENDIX
 ADVANCE IN KNOWLEDGE
 References
 

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  9. International Commission on Radiological Protection. Conversion coefficients for use in radiological protection against external radiation, adopted by the ICRP and ICRU in September 1995. Ann ICRP 1996;26(3-4):1–205. [Published correction appears in Ann ICRP 1997;27(3-4):163–164.][CrossRef]
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  18. Vano E, Prieto C, Fernandez JM, Gonzalez L, Sabate M, Galvan C. Skin dose and dose-area product values in patients undergoing intracoronary brachytherapy. Br J Radiol 2003;76:32–38.[Abstract/Free Full Text]
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  20. Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP 2000;30(2):7–67.[Medline]
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