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Title: MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators

Abstract

Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratoriesmore » such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.« less

Publication Date:
OSTI Identifier:
22649486
Resource Type:
Journal Article
Resource Relation:
Journal Name: Medical Physics; Journal Volume: 43; Journal Issue: 6; Other Information: (c) 2016 American Association of Physicists in Medicine; Country of input: International Atomic Energy Agency (IAEA)
Country of Publication:
United States
Language:
English
Subject:
61 RADIATION PROTECTION AND DOSIMETRY; 60 APPLIED LIFE SCIENCES; BRACHYTHERAPY; CALIBRATION; COMMISSIONING; DOSE RATES; DOSIMETRY; RADIATION DOSE DISTRIBUTIONS; RADIATION PROTECTION; RECOMMENDATIONS; SAFETY

Citation Formats

NONE. MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators. United States: N. p., 2016. Web. doi:10.1118/1.4957149.
NONE. MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators. United States. doi:10.1118/1.4957149.
NONE. 2016. "MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators". United States. doi:10.1118/1.4957149.
@article{osti_22649486,
title = {MO-A-BRC-00: TG167: Clinical Recommendations for Innovative Brachytherapy Devices and Applicators},
author = {NONE},
abstractNote = {Although a multicenter, Phase III, prospective, randomized trial is the gold standard for evidence-based medicine, it is rarely used to evaluate innovative radiotherapy devices because of many practical and ethical reasons. It is usually sufficient to compare the dose distributions and dose rates for determining equivalence of the innovative device to an existing one. Thus, quantitative evaluation of the dosimetric characteristics of an innovative brachytherapy device or application is a critical part in which physicists are actively involved. The physicist’s role, along with physician colleagues, in this process is highlighted for innovative products or applications and includes evaluation of 1) dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use, 2) risks and benefits from regulatory and safety perspectives, and 3) resource assessment and preparedness. Further, calibration methods should be traceable to a primary standards dosimetry laboratory such as NIST in the U.S. or to other primary standards dosimetry laboratory located elsewhere. Clinical users should follow standards as approved by their country’s regulatory agencies that approved such a brachytherapy device. Integration of this system into the medical source calibration infrastructure of secondary standard dosimetry laboratories such as the ADCLs is encouraged before a source is introduced into widespread routine clinical use. The AAPM and GEC-ESTRO have developed guidelines for the safe and consistent application of brachytherapy using innovative brachytherapy devices and applications. The current report covers regulatory approvals, calibration, dose calculations, radiobiological issues, and overall safety concerns that should be addressed during the commissioning stage preceding clinical use. These guidelines are based on review of requirements of the U.S. NRC, FDA, Department of Transportation, International Electrotechnical Commission Medical Electrical Equipment Standard 60601, European Commission for CE Marking, and institutional review boards and radiation safety committees. Learning Objectives: Understand the necessary dosimetric considerations for clinical implementation (including calibrations, dose calculations, and radiobiological aspects) to comply with existing societal dosimetric prerequisites for sources in routine clinical use. Evaluate risks and benefits from regulatory and safety perspectives. Identify necessary resources and create a plan for clinical introduction of innovative brachytherapy device or applications. Consultant for Theragenics Corp.; R. Nath, Consultant to Theragenics Corp.},
doi = {10.1118/1.4957149},
journal = {Medical Physics},
number = 6,
volume = 43,
place = {United States},
year = 2016,
month = 6
}
  • Purpose: (1) Evaluate the safety and radiation attenuation properties of PCISO, a bio-compatible, sterilizable 3D printing material by Stratasys, (2) establish a method for commissioning customized multi- and single-use 3D printed applicators, (3) report on use of customized vaginal cylinders used to treat a series of serous endometrial cancer patient. Methods: A custom film dosimetry apparatus was designed to hold a Gafchromic radio film segment between two blocks of PC-ISO and 3D-printed using a Fortus 400mc (StrataSys). A dose plan was computed using 13 dwell positions at 2.5 mm spacing and normalized to 1500 cGy at 1 cm. Film exposuremore » was compared to control tests in only air and only water. The average Hounsfield Unit (HU) was computed and used to verify water equivalency. For the clinical use cases, the physician specifies the dimensions and geometry of a custom applicator from which a CAD model is designed and printed. Results: The doses measured from the PC-ISO Gafchromic film test were within 1% of the dose measured in only water between 1cm and 6cm from the channel. Doses increased 7–4% measured in only air. HU range was 11–43. The applicators were sterilized using the Sterrad system multiple times without damage. As of submission 3 unique cylinders have been designed, printed, and used in the clinic. A standardizable workflow for commissioning custom 3D printed applicators was codified and will be reported. Conclusions: Quality assurance (QA) evaluation of the PC-ISO 3D-printing material showed that PC-ISO is a suitable material for a gynecological brachytherapy vaginal cylinder in a clinical setting. With the material commissioning completed, if the physician determines that a better treatment would Result, a customized design is fabricated with limited additional QA necessary. Although this study was specific to PC-ISO, the same setup can be used to evaluate other 3D-printing materials.« less
  • Purpose: and Leipzig applicators (VLAs) are single-channel brachytherapy surface applicators used to treat skin lesions up to 2cm diameter. Source dwell times can be calculated and entered manually after clinical set-up or ultrasound. This procedure differs dramatically from CT-based planning; the novelty and unfamiliarity could lead to severe errors. To build layers of safety and ensure quality, a multidisciplinary team created a protocol and applied Failure Modes and Effects Analysis (FMEA) to the clinical procedure for HDR VLA skin treatments. Methods: team including physicists, physicians, nurses, therapists, residents, and administration developed a clinical procedure for VLA treatment. The procedure wasmore » evaluated using FMEA. Failure modes were identified and scored by severity, occurrence, and detection. The clinical procedure was revised to address high-scoring process nodes. Results: Several key components were added to the clinical procedure to minimize risk probability numbers (RPN): -Treatments are reviewed at weekly QA rounds, where physicians discuss diagnosis, prescription, applicator selection, and set-up. Peer review reduces the likelihood of an inappropriate treatment regime. -A template for HDR skin treatments was established in the clinical EMR system to standardize treatment instructions. This reduces the chances of miscommunication between the physician and planning physicist, and increases the detectability of an error during the physics second check. -A screen check was implemented during the second check to increase detectability of an error. -To reduce error probability, the treatment plan worksheet was designed to display plan parameters in a format visually similar to the treatment console display. This facilitates data entry and verification. -VLAs are color-coded and labeled to match the EMR prescriptions, which simplifies in-room selection and verification. Conclusion: Multidisciplinary planning and FMEA increased delectability and reduced error probability during VLA HDR Brachytherapy. This clinical model may be useful to institutions implementing similar procedures.« less
  • Historically the strength of sealed brachytherapy sources has been described by many physical quantities, including true activity, apparent activity, and equivalent mass of radium. Recently, the AAPM Task Group 32 recommended that these quantities be replaced by a single quantity, air-kerma strength, with units of {mu}Gy m{sup 2} h{sup {minus}1}. A set of equations has been developed for unambiguously converting source strength estimates and renormalizing published dose-rate tables, which assume traditional quantities and units, into forms consistent with air-kerma strength. For commonly used brachytherapy sources, multiplicative conversion factors for each source-strength formalism and set of units are given. To convertmore » equivalent mass of radium to air-kerma strength requires a single multiplicative factor, 7.23 {mu}Gy m{sup 2} h{sup {minus}1}/mgRaEq, applicable to all sources. Based upon a review of vendor source specification practices, the factors for converting source strength of {sup 198}Au, {sup 103}Pd, and {sup 125}I seeds from apparent mCi to air-kerma strength are 2.06, 1.29, and 1.27 {mu}Gy m{sup 2} h{sup {minus}1}/mCi(apparent), respectively. These factors are independent of source geometry but depend on the nominal exposure rate constant value selected by the vendor. Conversion factors applicable to mass of radium or true activity depend upon both source geometry and radionuclide identity. Because many of these conversion factors depend upon vendor choices of physical constants and exposure rate constants, readers are cautioned to carefully review vendor source strength specification practices before adopting these values clinically. Finally, the relationships between the various source strength quantities and absorbed dose rate in the medium surrounding the source are elucidated.« less
  • The charge of Task Group 186 (TG-186) is to provide guidance for early adopters of model-based dose calculation algorithms (MBDCAs) for brachytherapy (BT) dose calculations to ensure practice uniformity. Contrary to external beam radiotherapy, heterogeneity correction algorithms have only recently been made available to the BT community. Yet, BT dose calculation accuracy is highly dependent on scatter conditions and photoelectric effect cross-sections relative to water. In specific situations, differences between the current water-based BT dose calculation formalism (TG-43) and MBDCAs can lead to differences in calculated doses exceeding a factor of 10. MBDCAs raise three major issues that are notmore » addressed by current guidance documents: (1) MBDCA calculated doses are sensitive to the dose specification medium, resulting in energy-dependent differences between dose calculated to water in a homogeneous water geometry (TG-43), dose calculated to the local medium in the heterogeneous medium, and the intermediate scenario of dose calculated to a small volume of water in the heterogeneous medium. (2) MBDCA doses are sensitive to voxel-by-voxel interaction cross sections. Neither conventional single-energy CT nor ICRU/ICRP tissue composition compilations provide useful guidance for the task of assigning interaction cross sections to each voxel. (3) Since each patient-source-applicator combination is unique, having reference data for each possible combination to benchmark MBDCAs is an impractical strategy. Hence, a new commissioning process is required. TG-186 addresses in detail the above issues through the literature review and provides explicit recommendations based on the current state of knowledge. TG-43-based dose prescription and dose calculation remain in effect, with MBDCA dose reporting performed in parallel when available. In using MBDCAs, it is recommended that the radiation transport should be performed in the heterogeneous medium and, at minimum, the dose to the local medium be reported along with the TG-43 calculated doses. Assignments of voxel-by-voxel cross sections represent a particular challenge. Electron density information is readily extracted from CT imaging, but cannot be used to distinguish between different materials having the same density. Therefore, a recommendation is made to use a number of standardized materials to maintain uniformity across institutions. Sensitivity analysis shows that this recommendation offers increased accuracy over TG-43. MBDCA commissioning will share commonalities with current TG-43-based systems, but in addition there will be algorithm-specific tasks. Two levels of commissioning are recommended: reproducing TG-43 dose parameters and testing the advanced capabilities of MBDCAs. For validation of heterogeneity and scatter conditions, MBDCAs should mimic the 3D dose distributions from reference virtual geometries. Potential changes in BT dose prescriptions and MBDCA limitations are discussed. When data required for full MBDCA implementation are insufficient, interim recommendations are made and potential areas of research are identified. Application of TG-186 guidance should retain practice uniformity in transitioning from the TG-43 to the MBDCA approach.« less
  • Purpose: The aim of this study was to characterize the levels of artifacts and distortions of titanium applicators on 3.0-Tesla magnetic resonance imaging (MRI). Methods and Materials: Fletcher-Suit-Delclos-style tandem and ovoids (T and O) and tandem and ring applicator (T and R) were examined. The quality assurance (QA) phantoms for each applicator were designed and filled with copper sulphate solution (1.5 g/l). The artifacts were quantified with the registration of corresponding computed tomography (CT) images. A favorable MR sequence was searched in terms of artifacts. Using the sequence, the artifacts were determined. The geometric distortions induced by the applicators weremore » quantified through each registration of CT and MRI without applicators. The artifacts of T and O were also evaluated on in vivo MRI datasets of 5 patients. Results: T1-weighted MRI with 1-mm slice thickness was found as a favorable MR sequence. Applying the sequence, the artifacts at the tandem tip of T and O and T and R were determined as 1.5 {+-} 0.5 mm in a superior direction in phantom studies. In the ovoids of T and O, we found artifacts less than 1.5 {+-} 0.5 mm. The artifacts of a T and O tandem in vivo were found as less than 2.6 {+-} 1.3 mm on T1-weighted MRI, whereas less than 6.9 {+-} 3.4 mm on T2-weighted MRI. No more than 1.2 {+-} 0.6 mm (3.0 {+-} 1.5 mm) of distortions, due to a titanium applicator, were measured on T1-weighted MRI (T2-). Conclusion: In 3.0-Tesla MRI, we found the artifact widths at the tip of tandem were less than 1.5 {+-} 0.5 mm for both T and O and T and R when using T1-weighted MRI in phantom studies. However, exclusive 3.0-Tesla MRI-guided brachytherapy planning with a titanium applicator should be cautiously implemented.« less