Radiation Oncology Device Approval in the United States and Canada.

Background Medical devices are a crucial component in the field of radiation oncology. The review and licensing of radiation oncology devices (RODs) is managed on a national basis in Canada by Health Canada and in the United States by the Food and Drug Administration (FDA). The purpose of this study was to examine differences in ROD licensing timelines between Health Canada and the FDA that may impact the ability of Canadians to access the most up-to-date radiation oncology care. Methods A list of ROD was compiled by searching keywords, manufacturers, and proprietary device names in the publicly accessible Canadian Medical Devices Active Licence Listing (MDALL) and the American Establishment Registration & Device Listing and the 510(k) Premarket Notification database. ROD licensing dates were then obtained through both databases. ROD were included if they were licensed in both countries. Results A total of 51 RODs were included in this study and it was found that 71% (36/51) were issued licenses for sale in the United States before Canada, at a mean of 506 days sooner (median [IQR] = 282 [326.5]). No trends in licensing dates were found by stratifying devices by type. Analyses were limited to the date of licensing only, as Health Canada provided no publicly-available information regarding submission milestones such as first submission date for the RODs studied. Conclusions The majority of radiation oncology devices examined were licensed for sale in the USA before Canada. Due to the absence of publicly available information regarding initial ROD application date, we cannot evaluate the impact of the approval process on the overall difference in licensing date. Importantly, this research highlights a lack of publicly-available information from Health Canada regarding the medical device approval process for the radiation oncology devices studied herein.

Quantifying construction vibration effects on daily radiotherapy treatments.

The existing two-story parkade is being replaced by a four-story parkade on a hospital campus. The parkade is across a two-lane access road from a cancer center with a nine-linear accelerator radiotherapy department in the basement. The new parkade is supported by over 280 drilled and cased pilings installed at depths between 10 and 25 m depending on the underlying soil strata and varying diameters, up to 1.5 m. The construction work in such close proximity to the radiation therapy department resulted in significant vibrations being felt in the simulation and treatment vaults. The amplitude and frequency of the vibration was measured. Using vendor supplied documentation, the total vibratory amplitude of the linear accelerators in use within the department was calculated. The results fell outside of specification, resulting in changes to the way the project preceded following discussion with the project management team.

Clinical implementation of AXB from AAA for breast: Plan quality and subvolume analysis.

PURPOSE: Two dose calculation algorithms are available in Varian Eclipse software: Anisotropic Analytical Algorithm (AAA) and Acuros External Beam (AXB). Many Varian Eclipse-based centers have access to AXB; however, a thorough understanding of how it will affect plan characteristics and, subsequently, clinical practice is necessary prior to implementation. We characterized the difference in breast plan quality between AXB and AAA for dissemination to clinicians during implementation. METHODS: Locoregional irradiation plans were created with AAA for 30 breast cancer patients with a prescription dose of 50 Gy to the breast and 45 Gy to the regional node, in 25 fractions. The internal mammary chain (IMCCTV ) nodes were covered by 80% of the breast dose. AXB, both dose-to-water and dose-to-medium reporting, was used to recalculate plans while maintaining constant monitor units. Target coverage and organ-at-risk doses were compared between the two algorithms using dose-volume parameters. An analysis to assess location-specific changes was performed by dividing the breast into nine subvolumes in the superior-inferior and left-right directions. RESULTS: There were minimal differences found between the AXB and AAA calculated plans. The median difference between AXB and AAA for breastCTV V95% , was <2.5%. For IMCCTV , the median differences V95% , and V80% were <5% and 0%, respectively; indicating IMCCTV coverage only decreased when marginally covered. Mean superficial dose increased by a median of 3.2 Gy. In the subvolume analysis, the medial subvolumes were "hotter" when recalculated with AXB and the lateral subvolumes "cooler" with AXB; however, all differences were within 2 Gy. CONCLUSION: We observed minimal difference in magnitude and spatial distribution of dose when comparing the two algorithms. The largest observable differences occurred in superficial dose regions. Therefore, clinical implementation of AXB from AAA for breast radiotherapy is not expected to result in changes in clinical practice for prescribing or planning breast radiotherapy.

Deep inspiration breath hold level variability and deformation in locoregional breast irradiation.

PURPOSE: The purpose of this study was to evaluate the dosimetric effect of breath hold level variability and deformation on breast, chest wall, internal mammary chain (IMC) nodes, and heart. METHODS AND MATERIALS: Left-sided post-lumpectomy (n = 12) and postmastectomy (n = 3) patients underwent deep inspiration breath hold (DIBH) and exhale breath hold (EBH) computed tomography (CT) scans. Forward-planned locoregional breast plans were created on the DIBH scan. Two effects were modeled assuming no setup uncertainties: residual motion within the gating window and systematically shallow breath hold levels (BHLs). Real-time position management (RPM) was used to monitor BHL at simulation and during treatment. The RPM data were scaled to simulate BHL variation within symmetric gating window widths of ±1, 3, 5, and 7 mm; the dosimetric impact of this motion was simulated in the treatment planning system. Systematically "shallow" BHL errors were modeled using deformable image registration to map the patient trajectory from DIBH to EBH (n = 12). The deformable vector fields were scaled to produce synthetic CT scans modeling patient position during breath holds 1, 3, 5, and 7 mm shallower than simulator BHL. The original treatment plans were applied to the synthetic CTs and dose was recalculated. RESULTS: Acceptable plan quality was maintained for most patients with motion within gating windows up to ±7 mm. Patients with shallow median BHLs experienced loss of coverage at simulated gating windows ±5 mm or larger. At systematic 3 mm shallow BHL error, 4/12 patients had clinical target volume IMC V80% < 99%; this increased to 11/12 patients at 5 mm. Change in heart dose from systematic BHL errors was negligible. CONCLUSIONS: Motion within gating windows has minimal dosimetric impact for most BHL variability; however, loss of IMC coverage can occur even for small gating windows when BHLs are systematically shallow. This can be mitigated by restricting lower BHL tolerances or accounting for known uncertainties in planning.

What Conditions Make Proton Beam Therapy Financially Viable in Western Canada?

Background Proton beam therapy (PBT) is available in many western and Asian countries, but there is no clinical, gantry-based PBT facility in Canada. Methods A cost analysis was conducted from the Alberta Ministry of Health perspective with a 15-year horizon. Estimated costs were: PBT unit, facility development as part of an ongoing capital project, electricity, maintenance contract, and staffing. Revenues were: savings from stopping USA referrals, avoiding the costs of standard radiation therapy (RT) for Albertans receiving PBT instead, and cost-recovery charges for out-of-province patients. Results The Ministry of Health funded 15 Albertans for PBT in the USA in the 2014/15 fiscal year (mean CAD$ 237,348/patient). A single-vault, compact PBT unit operating 10 hours/day could treat 250 patients annually. A 100 Albertans, with accepted indications, such as the curative-intent treatment of chordomas, ocular melanomas, and selected pediatric cancers, would likely benefit annually from PBT's improved conformality and/or reduced integral dose compared to RT. The estimated capital cost was $40 million for a single beamline built within an ongoing capital project. Operating costs were $4.8 million/year at capacity. With 50% capacity reserved for non-Albertans at a cost recovery of $45,000/patient, a Western Canadian PBT facility would achieve net positive cash flow by year eight of clinical operations, assuming Alberta-to-USA referrals reach 21 patients/year by 2024 and increase at 3%/year thereafter. Sensitivity analysis indicates the lifetime net savings is robust to the assumptions made. Conclusion This business case, based on Canadian costing data and estimates, demonstrates the potential for a financially viable PBT facility in Western Canada.

Deep inspiration breath-hold produces a clinically meaningful reduction in ipsilateral lung dose during locoregional radiation therapy for some women with right-sided breast cancer.

PURPOSE: The goal of the work described here was to determine whether deep inspiration breath-hold (DIBH) produces a clinically meaningful reduction in pulmonary dose compared with free breathing (FB) during locoregional radiation for right-sided breast cancer. METHODS AND MATERIALS: Four-field, modified-wide tangent plans with full nodal coverage were developed for 30 consecutive patients on paired DIBH and FB CT scans. Nodes were contoured according to European Society for Radiotherapy and Oncology guidelines. Plan metrics were compared using Wilcoxon signed-rank testing. RESULTS: In 21 patients (70%), there was a ≥5% reduction in ipsilateral lung V20Gy with DIBH compared with FB. The mean decrease in ipsilateral lung V20Gy was 7.8% (0%-20%, P < .001). The mean lung dose decreased on average by 3.4 Gy with DIBH (-0.2 to 9.1, P < .001). The mean reduction in liver volume receiving 50% of the prescribed dose was 42.3 cm3 (0-178.9 cm3, P < .001). CONCLUSIONS: DIBH reduced ipsilateral lung V20Gy by ≥5% in the majority of patients. For some patients, the volume of liver receiving a potentially toxic dose decreased with DIBH. DIBH should be available as a treatment strategy to reduce ipsilateral lung V20Gy prior to compromising internal mammary chain nodal coverage for patients with right-sided breast cancer during locoregional radiation therapy if the V20Gy on FB exceeds 30%.

Technical Note: Issues related to external marker block placement for deep inspiration breath hold breast radiotherapy.

PURPOSE: It has been suggested that the Real-time Position Management (RPM) marker block should be placed directly on the breast or sternum to verify deep inspiration breath hold (DIBH) level for breast radiotherapy. We explore three potential issues with this practice: (a) surface dose effect of placing the marker block in the primary beam; (b) effect of marker block tilt on the accuracy of the RPM system; and (c) correlation between marker block positions on the patient surface and internal chest wall position. METHODS: (a) The surface dose under the two-, four-, and six-dot marker blocks was measured at incident angles of 0° and 30°; (b) the motion amplitude detected when using the two- and six-dot marker blocks was recorded for block tilts from 0° to 60° about the RPM camera line of sight; (c) the correlation between median displacement of the chest wall and median displacement of the surface contour between breath holds was investigated for superior, middle, and inferior block positions using contours extracted from portal images of eight left-sided breast cancer patients. RESULTS: (a) The marker blocks increased the surface dose for a 6 MV direct field by 48.2-52.2% of Dmax ; (b) at lateral tilts greater than 10°, the two-dot marker block overestimated the motion amplitude; however, the six-dot marker block amplitude remained accurate up to 60°; (c) the whole, superior, and middle surface positions were strongly correlated with chest wall displacement (R2 = 0.83; R2 = 0.90; R2 = 0.83), whereas the inferior position was moderately correlated (R2 = 0.36). CONCLUSIONS: The RPM marker block can be placed on the breast for DIBH treatments; however, caution should be used regarding surface dose effects. The two-dot marker block should not be used for block tilts beyond 20°. Marker block placement at a middle or superior position on the breast results in the strongest correlation with chest wall position.

Evaluation of target and cardiac position during visually monitored deep inspiration breath-hold for breast radiotherapy.

A low-resource visually monitored deep inspiration breath-hold (VM-DIBH) technique was successfully implemented in our clinic to reduce cardiac dose in left-sided breast radiotherapy. In this study, we retrospectively characterized the chest wall and heart positioning accuracy of VM-DIBH using cine portal images from 42 patients. Central chest wall position from field edge and in-field maximum heart distance (MHD) were manually measured on cine images and compared to the planned positions based on the digitally reconstructed radiographs (DRRs). An in-house program was designed to measure left anterior descending artery (LAD) and chest wall separation on the planning DIBH CT scan with respect to breath-hold level (BHL) during simulation to determine a minimum BHL for VM-DIBH eligibility. Systematic and random setup uncertainties of 3.0 mm and 2.6 mm, respectively, were found for VM-DIBH treatment from the chest wall measurements. Intrabeam breath-hold stability was found to be good, with over 96% of delivered fields within 3 mm. Average treatment MHD was significantly larger for those patients where some of the heart was planned in the field compared to patients whose heart was completely shielded in the plan (p < 0.001). No evidence for a minimum BHL was found, suggesting that all patients who can tolerate DIBH may yield a benefit from it.

Realistic respiratory motion margins for external beam partial breast irradiation.

PURPOSE: Respiratory margins for partial breast irradiation (PBI) have been largely based on geometric observations, which may overestimate the margin required for dosimetric coverage. In this study, dosimetric population-based respiratory margins and margin formulas for external beam partial breast irradiation are determined. METHODS: Volunteer respiratory data and anterior-posterior (AP) dose profiles from clinical treatment plans of 28 3D conformal radiotherapy (3DCRT) PBI patient plans were used to determine population-based respiratory margins. The peak-to-peak amplitudes (A) of realistic respiratory motion data from healthy volunteers were scaled from A = 1 to 10 mm to create respiratory motion probability density functions. Dose profiles were convolved with the respiratory probability density functions to produce blurred dose profiles accounting for respiratory motion. The required margins were found by measuring the distance between the simulated treatment and original dose profiles at the 95% isodose level. RESULTS: The symmetric dosimetric respiratory margins to cover 90%, 95%, and 100% of the simulated treatment population were 1.5, 2, and 4 mm, respectively. With patient set up at end exhale, the required margins were larger in the anterior direction than the posterior. For respiratory amplitudes less than 5 mm, the population-based margins can be expressed as a fraction of the extent of respiratory motion. The derived formulas in the anterior/posterior directions for 90%, 95%, and 100% simulated population coverage were 0.45A/0.25A, 0.50A/0.30A, and 0.70A/0.40A. The differences in formulas for different population coverage criteria demonstrate that respiratory trace shape and baseline drift characteristics affect individual respiratory margins even for the same average peak-to-peak amplitude. CONCLUSIONS: A methodology for determining population-based respiratory margins using real respiratory motion patterns and dose profiles in the AP direction was described. It was found that the currently used respiratory margin of 5 mm in partial breast irradiation may be overly conservative for many 3DCRT PBI patients. Amplitude alone was found to be insufficient to determine patient-specific margins: individual respiratory trace shape and baseline drift both contributed to the dosimetric target coverage. With respiratory coaching, individualized respiratory margins smaller than the full extent of motion could reduce planning target volumes while ensuring adequate coverage under respiratory motion.

When is respiratory management necessary for partial breast intensity modulated radiotherapy: a respiratory amplitude escalation treatment planning study.

PURPOSE: The impact of typical respiratory motion amplitudes (∼2 mm) on partial breast irradiation (PBI) is minimal; however, some patients have larger respiratory amplitudes that may negatively affect dose homogeneity. Here we determine at what amplitude respiratory management may be required to maintain plan quality. METHODS AND MATERIALS: Ten patients were planned with PBI IMRT. Respiratory motion (2-20 mm amplitude) probability density functions were convolved with static plan fluence to estimate the delivered dose. Evaluation metrics included target coverage, ipsilateral breast hotspot, homogeneity, and uniformity indices. RESULTS: Degradation of dose homogeneity was the limiting factor in reduction of plan quality due to respiratory motion, not loss of coverage. Hotspot increases were observed even at typical motion amplitudes. At 2 and 5 mm, 2/10 plans had a hotspot greater than 107% and at 10 mm this increased to 5/10 plans. Target coverage was only compromised at larger amplitudes: 5/10 plans did not meet coverage criteria at 15 mm amplitude and no plans met minimum coverage at 20 mm. CONCLUSIONS: We recommend that if respiratory amplitude is greater than 10 mm, respiratory management or alternative radiotherapy should be considered due to an increase in the hotspot in the ipsilateral breast and a decrease in dose homogeneity.

Measurement of time delays in gated radiotherapy for realistic respiratory motions.

PURPOSE: Gated radiotherapy is used to reduce internal motion margins, escalate target dose, and limit normal tissue dose; however, its temporal accuracy is limited. Beam-on and beam-off time delays can lead to treatment inefficiencies and/or geographic misses; therefore, AAPM Task Group 142 recommends verifying the temporal accuracy of gating systems. Many groups use sinusoidal phantom motion for this, under the tacit assumption that use of sinusoidal motion for determining time delays produces negligible error. The authors test this assumption by measuring gating time delays for several realistic motion shapes with increasing degrees of irregularity. METHODS: Time delays were measured on a linear accelerator with a real-time position management system (Varian TrueBeam with RPM system version 1.7.5) for seven motion shapes: regular sinusoidal; regular realistic-shape; large (40%) and small (10%) variations in amplitude; large (40%) variations in period; small (10%) variations in both amplitude and period; and baseline drift (30%). Film streaks of radiation exposure were generated for each motion shape using a programmable motion phantom. Beam-on and beam-off time delays were determined from the difference between the expected and observed streak length. RESULTS: For the system investigated, all sine, regular realistic-shape, and slightly irregular amplitude variation motions had beam-off and beam-on time delays within the AAPM recommended limit of less than 100 ms. In phase-based gating, even small variations in period resulted in some time delays greater than 100 ms. Considerable time delays over 1 s were observed with highly irregular motion. CONCLUSIONS: Sinusoidal motion shapes can be considered a reasonable approximation to the more complex and slightly irregular shapes of realistic motion. When using phase-based gating with predictive filters even small variations in period can result in time delays over 100 ms. Clinical use of these systems for patients with highly irregular patterns of motion is not advised due to large beam-on and beam-off time delays.

Accounting for respiratory motion in partial breast intensity modulated radiotherapy during treatment planning: a new patient selection metric.

PURPOSE: External beam partial breast irradiation intensity modulated radiotherapy (PBI IMRT) plans experience degradation in coverage and dose homogeneity when delivered during respiration. We examine which characteristics of the breast and seroma result in unacceptable plan degradation due to respiration. METHODS: Thirty-six patient datasets were planned with inverse-optimised PBI IMRT. Population respiratory data were used to create a probability density function. This probability density function (PDF) was convolved with the static plan fluences to calculate the delivered dose with respiration. To quantify the difference between static and respiratory plan quality, we analysed the mean dose shift of the target dose volume histogram (DVH), the dose shift at 95% of the volume and the dose shift at the hotspot to 2 cm(3)of the volume. We explore which patient characteristics indicate a clinically significant degradation in delivered plan quality due to respiration. RESULTS: Dose homogeneity constraints, rather than dosimetric coverage, were the limiting factors for all patient plans. We propose the dose evaluation volume-to-planning target volume (DEV-to-PTV) ratio as a delineating metric for identifying patient plans that will be more degraded by respiratory motion. The DEV-to-PTV ratio may be a more robust metric than ipsilateral breast volume because the seroma volume is contoured more consistently between physicians and clinics. CONCLUSIONS: For patients with a DEV-to-PTV ratio less than 55% we recommend either not using PBI IMRT or employing motion management. Small DEV-to-PTV ratios occur when the seroma is close to inhomogeneities (i.e. air/lung), which exacerbates the dosimetric effect of respiratory motion. For small breast sizes it is unlikely that the DEV-to-PTV ratio will meet these criteria.

A comparison of phase, amplitude, and velocity binning for cone-beam computed tomographic projection-based motion reconstruction.

PURPOSE: We previously developed a motion estimation technique based on direct cone-beam projection analysis. It is able to reconstruct the complete motion trajectory of a radio-opaque marker, including cycle-to-cycle variability, using respiratory binning of the projection images. This paper investigates the use of phase, amplitude, and amplitude-velocity binning in the context of projection-based cone-beam motion estimation (CBME). METHODS AND MATERIALS: We simulated cone-beam computed tomographic scans of 160 tumor trajectories estimated by a CyberKnife Synchrony System (Accuray, Sunnyvale, CA), and reconstructed the complete trajectory with CBME using phase, amplitude, and amplitude-velocity binning of the projection data. Various numbers of respiratory bins, from 1 (no binning) to 100, were used for phase and amplitude binning, while 1 to 100 amplitude bins with 4 velocity bins were used for amplitude-velocity binning. From this large pool of data, we correlated the reconstruction accuracy with bin type, total number of bins, number of breathing cycles per bin, and the position of the bin within the breathing cycle. RESULTS: CBME predicted the true motion of the marker with a 3-dimensional (3D) mean root mean square (RMS) error of 0.24 mm for amplitude-velocity binning, 0.31 mm for amplitude binning, and 0.52 mm for phase binning. Reconstruction 3D RMS error increased to over 1 mm when less than 3 breathing cycles contributed to a bin. We found that reconstruction accuracy was optimized when about 20 bins were used. Accuracy also decreased in bins located around the inhale portion of the breath cycle, compared with the mid- and end-exhale positions. CONCLUSIONS: This study provides a quantitative assessment of phase, amplitude, and amplitude-velocity binning for CBME. A joint binning approach should be used to give both the accuracy of amplitude binning, as well as the robustness of phase binning, in areas of limited motion sampling.

Quantification of VX vapor in ambient air by liquid chromatography isotope dilution tandem mass spectrometric analysis of glass bead filled sampling tubes.

An analysis method has been developed for determining low parts-per-quadrillion by volume (ppqv) concentrations of nerve agent VX vapor actively sampled from ambient air. The method utilizes glass bead filled depot area air monitoring system (DAAMS) sampling tubes with isopropyl alcohol extraction and isotope dilution using liquid chromatography coupled with a triple-quadrupole mass spectrometer (LC/MS/MS) with positive ion electrospray ionization for quantitation. The dynamic range was from one-tenth of the worker population limit (WPL) to the short-term exposure limit (STEL) for a 24 L air sample taken over a 1 h period. The precision and accuracy of the method were evaluated using liquid-spiked tubes, and the collection characteristics of the DAAMS tubes were assessed by collecting trace level vapor generated in a 1000 L continuous flow chamber. The method described here has significant improvements over currently employed thermal desorption techniques that utilize a silver fluoride pad during sampling to convert VX to a higher volatility G-analogue for gas chromatographic analysis. The benefits of this method are the ability to directly analyze VX with improved selectivity and sensitivity, the injection of a fraction of the extract, quantitation using an isotopically labeled internal standard, and a short instrument cycle time.

Time delays in gated radiotherapy.

In gated radiotherapy, the accuracy of treatment delivery is determined by the accuracy with which both the imaging and treatment beams are gated. If the time delays (the time between the target entering/leaving the gated region and the first/last image acquired or treatment beam on/off) for the imaging and treatment systems are in the opposite directions, they may increase the required internal target volume (ITV) margin, above that indicated by the tolerance for either system measured individually. We measured a gating system's time delay on 3 fluoroscopy systems, and 3 linear accelerator treatment beams, using a motion phantom of known geometry, varying gating type (amplitude vs. phase), beam energy, dose rate, and period. The average beam on imaging time delays were -0.04 +/- 0.05 s (amplitude, 1 SD), -0.11 +/- 0.04 s (phase); while the average beam off imaging time delays were -0.18 +/- 0.08 s (amplitude) and -0.15 +/- 0.04 s (phase). The average beam on treatment time delays were 0.09 +/- 0.02 s (amplitude, 1 SD), 0.10 +/- 0.03 s (phase); while the average beam off time delays for treatment beams were 0.08 +/- 0.02 s (amplitude) and 0.07 +/- 0.02 s (phase). The negative value indicates the images were acquired early, and the positive values show the treatment beam was triggered late. We present a technique for calculating the margin necessary to account for time delays and found that the difference between the imaging and treatment time delays required a significant increase in the ITV margin in the direction of tumor motion at the gated level.

Development and evaluation of an ultrasound-guided tracking and gating system for hepatic radiotherapy.

PURPOSE: Respiratory motion must be accounted for daily in order to permit optimum radiotherapy of hepatic malignancies. However, existing tracking systems are often invasive or poorly tolerated by patients. The authors describe the development and validation of an ultrasound-guided tracking and gating system for stereotactic body radiation therapy of the liver. METHODS: This noninvasive system is designed to determine the correlation between tumor and external fiducial motion and to verify the optimum gating level for treatment delivery daily. A tracked ultrasound probe moves with patient respiration, obtaining 2D ultrasound images of tumor motion throughout the respiratory cycle. The target volume is registered to the static radiotherapy treatment beams in order to verify optimum gating levels. These gating levels are then transferred to an existing gating system for treatment delivery. The authors examined the temporal and spatial accuracy of this system using a custom-built phantom and verified the accuracy of gating level transfer and delivery. RESULTS: The temporal accuracy of the ultrasound-guided system was shown to be comparable to the existing clinical x-ray imaging system. Using ultrasound rather than x-rays to image internal targets provides good soft-tissue contrast without the invasiveness of implanting fiducial markers. High frame rates enable continuous monitoring of the target throughout the respiratory cycle. The authors anticipate this passive monitoring system should be well tolerated by patients. CONCLUSIONS: The system developed provides good quality video of the laboratory motion phantom and can be successfully used in gated beam delivery.

Prostate volume contouring: a 3D analysis of segmentation using 3DTRUS, CT, and MR.

PURPOSE: This study evaluated the reproducibility and modality differences of prostate contouring after brachytherapy implant using three-dimensional (3D) transrectal ultrasound (3DTRUS), T2-weighted magnetic resonance (MR), and computed tomography (CT) imaging. METHODS AND MATERIALS: Seven blinded observers contoured 10 patients' prostates, 30 day postimplant, on 3DTRUS, MR, and CT images to assess interobserver variability. Randomized images were contoured twice by each observer. We analyzed length and volume measurements and performed a 3D analysis of intra- and intermodality variation. RESULTS: Average volume ratios were 1.16 for CT/MR, 0.90 for 3DTRUS/MR, and 1.30 for CT/3DTRUS. Overall contouring variability was largest for CT and similar for MR and 3DTRUS. The greatest variability of CT contours occurred at the posterior and anterior portions of the midgland. On MR, overall variability was smaller, with a maximum in the anterior region. On 3DTRUS, high variability occurred in anterior regions of the apex and base, whereas the prostate-rectum interface had the smallest variability. The shape of the prostate on MR was rounder, with the base and apex of similar size, whereas CT contours had broad, flat bases narrowing toward the apex. The average percent of surface area that was significantly different (95% confidence interval) for CT/MR was 4.1%; 3DTRUS/MR, 10.7%; and CT/3DTRUS, 6.3%. The larger variability of CT measurements made significant differences more difficult to detect. CONCLUSIONS: The contouring of prostates on CT, MR, and 3DTRUS results in systematic differences in the locations of and variability in prostate boundary definition between modalities. MR and 3DTRUS display the smallest variability and the closest correspondence.

Comparison of core needle breast biopsy techniques: freehand versus three-dimensional US guidance.

RATIONALE AND OBJECTIVES: No single method is generally accepted for evaluating the accuracy of breast biopsy techniques before their clinical implementation. The purpose of this study was to test a new process for evaluating biopsy techniques by using it in the evaluation of a prototype three-dimensional ultrasound (US)-guided biopsy device. MATERIALS AND METHODS: The biopsy accuracy of a new three-dimensional US-guided breast biopsy device was compared to that of the accepted clinical practice of biopsy by expert radiologists with two-dimensional freehand US guidance. Biopsies were performed in chicken tissue phantoms containing 3.2-mm lesions made of poly(vinyl alcohol) cryogel. The criterion for a successful biopsy was the presence of lesion in the sample. The equivalence limit difference tested was 10% by using a power of 90% and a two-sided test significance level, a, of 10%. RESULTS: The biopsy success rate of the three-dimensional US-guided system (96%) was equivalent to that of expert radiologists using two-dimensional freehand US guidance (94.5%) in tissue phantoms containing poly(vinyl alcohol) cryogel lesions. CONCLUSION: This evaluation procedure is a valuable precursor to clinical trials in the assessment of biopsy techniques. The three-dimensional US-guided breast biopsy system provides a suitable alternative to two-dimensional freehand US guidance for biopsy of breast cancer.