A method for empirically validating FMEA RPN scores in a radiation oncology clinic using physics QC data.

In failure modes and effects analysis (FMEA), the components of the risk priority number (RPN) for a failure mode (FM) are often chosen by consensus. We describe an empirical method for estimating the occurrence (O) and detectability (D) components of a RPN. The method requires for a given FM that its associated quality control measure be performed twice as is the case when a FM is checked for in an initial physics check and again during a weekly physics check. If instances of the FM caught by these checks are recorded, O and D can be computed. Incorporation of the remaining RPN component, Severity, is discussed. This method can be used as part of quality management design ahead of an anticipated FMEA or afterwards to validate consensus values.

Effect of beam profile measurement on arc therapy plan quality assurance: a case study.

We present an example when profile measurement and modeling of an Elekta Agility multileaf collimator (MLC) had a large effect specifically on arc therapy plan quality assurance (QA) results using ArcCheck. ArcCheck absolute dose measurements of these plans were systematically lower than planned by 3-10%. Failing QA results were seen even with unmodulated static and conformal arcs. Furthermore, the effect was found to be dependent on collimator angle, with worse results associated with near-zero collimator angles. In contrast, step-and-shoot QA results were not affected. Changing the beam model to match steeper profile measurements obtained using a different measurement device resolved the problem. This case study demonstrates that conventional gamma index analysis can be sensitive to small profile modeling changes.

Depth dose perturbation by a hydrogel fiducial marker in a proton beam.

The purpose of this study was to evaluate proton depth dose perturbation caused by a radio-opaque hydrogel fiducial marker. Electronic proton stopping powers in the hydrogel were calculated for energies 0.5-250 MeV, and Monte Carlo simulations were generated of hydrogel vs. gold markers placed at various water phantom depths in a generic proton beam. Across the studied energy range, the gel/water stopping power ratio was 1.0146 to 1.0160. In the Monte Carlo simulation, the hydrogel marker caused no discernible perturbation of the proton percent depth-dose (PDD) curve. In contrast, the gold marker caused dose reductions of as much as 20% and dose shadowing regions as long as 6.5 cm. In contrast to gold markers, the radio-opaque hydrogel marker causes negligible proton depth dose perturbation. This factor may be taken into consideration for image-guided proton therapy at facilities with suitable imaging modalities.

PRECISE: Preoperative Radiation Therapy to Elicit Critical Immune Stimulating Effects - A Phase 2 Clinical Trial.

PURPOSE: Radiation therapy is an underinvestigated tool for priming the immune system in intact human breast cancers. We sought here to investigate if a preoperative radiation therapy boost delivered was associated with a significant change in tumor-infiltrating lymphocytes (TILs) in the tumor in estrogen receptor positive, HER2Neu nonamplified breast cancers. METHODS AND MATERIALS: A total of 20 patients were enrolled in a phase 2 clinical trial and received either 7.5 Gy × 1 fraction or 2 Gy × 5 fractions, completed 6 to 8 days before surgery. Percent stromal TILs were evaluated on hematoxylin and eosin-stained samples. Short-term safety was assessed based on time to surgery, toxicities, and cosmesis up to 6 months after boost. RESULTS: Stromal TIL increased 6 to 8 days after completion of boost radiation therapy (median 3.0 [IQR, 1.0-6.5]) before radiation therapy versus median 5.0 (IQR, 1.5-8.0) after radiation therapy, P = .0037. Zero grade ≥3 toxicities up to 6 months after boost were experienced. In all, 94% (16/17) patients with 6-month follow-up cosmetic assessment after breast conservation had good-excellent cosmesis by physician assessment. CONCLUSION: In this phase 2 trial, preoperative radiation therapy boost resulted in a short-term increase in stromal TIL with minimal toxicities. Preoperative breast radiation therapy appears to be safe and may be a feasible means for priming the tumor microenvironment.

Accelerated partial-breast irradiation: the current state of our knowledge.

Breast-conserving therapy consisting of segmental mastectomy followed by whole-breast irradiation (WBI) has become widely accepted as an alternative to mastectomy as a treatment for women with early-stage breast cancer. Accelerated partial-breast irradiation (APBI) is a shorter, alternative radiation technique for select patients with favorable early-stage breast cancer. We review here the different modalities of APBI delivery and discuss the possible benefits and harms associated with these treatments.

It's the little THANGS: Recording frequently unreported errors for dosimetry quality improvement.

The reporting of errors resulting in dose deviations are well-studied. Less studied is the amount of inconsequential errors that will not harm the patient but could lead to inefficiency. This paper reports an institutional effort to quantify and reduce these less significant errors. Dosimetry items discovered during physicist plan/record and verify (R&V) check prior to treatment were recorded in a shared document and called Therapy Anomaly Gathering System (THANGS) and individual items were called a "thang." Items were categorized to 1 of 4 types: Treatment Plan, Plan Document, R&V, and Secondary MU. The aggregate numbers were presented to the dosimetry staff at regular staff meetings. It was emphasized to the staff that this was a Quality Improvement (QI) study and would not be used punitively. Thangs were tracked over a 4-year period. In Q1 of year 1 of the study, the average number of errors identified was 179/month. This was reduced to 114/month by Q4 of year 1 and 68/month by the end of year 4, a 62% reduction. The number of errors/plan in Q1 Year 1 was 1.25, and that was reduced by Q4 Year 4 to 0.4, a 68% reduction. The percentage of errors by type did not vary much over the 4 years. By far, R&V errors were the most common, and QI efforts were primarily aimed at them. We have developed a simple method to identify areas in dosimetric work that are vulnerable to minor errors and, through consistent reminders, drastically reduce them. This leads to a seamless throughput for a given plan ultimately resulting in improved physics, therapist, and most importantly patient satisfaction.

Implementation and Evaluation of a TG-275 Key Recommendation: An Additional Early Physics Check.

PURPOSE: We report our experience of performing an extra, earlier physics plan check as recommended by the American Association of Physicists in Medicine Task Group 100 and Task Group 275 reports. We assessed utilization and timing of the extra check as well as the time required in a medium-sized clinic. METHODS AND MATERIALS: We retrospectively extracted and analyzed timestamp data from the record and verify system for the quality checklist (QCL) items related to treatment planning and physics "prechecks" for 3487 patients treated at our institution from February 2017 to February 2021. The dosimetry staff was interviewed for their perception of the value and efficacy of the practice. RESULTS: Physics prechecks were requested for 19.0% of plans. The number of requests declined from 43.9% of cases in 2017 to 18.4% in 2018. The introduction of automated plan-check tools and a dosimetrist checklist further contributed to a drop in number of precheck requests to 3.5% in 2019. For patients who received a physics precheck, the treatment planning process was a median 3.6 hours longer compared with those without (P < .001). A total of 12.9% of the precheck requests were canceled by the dosimetrist after waiting a median time of 5.3 hours. There was a strong positive correlation (0.899) between a precheck being requested and the time remaining until treatment start. Higher complexity plans and plans with a specific concern (eg, possible collision) were more likely to have a precheck requested. CONCLUSIONS: Physics prechecks have become standard practice for certain cases in our clinic. However, the perception in the department was that, as a universal practice, waiting for a precheck was not worth the time saved redoing work on the few cases in which an error was caught. Dosimetrist access to automated checking tools and checklists, which were motivated by the precheck process, contributed to this perception.

On-line localization of the lumpectomy cavity using surgical clips.

PURPOSE: To present an on-line image guidance procedure for external beam accelerated partial breast irradiation based on cone-beam computed tomography (CBCT) imaging of surgical clips; and to estimate the possible clinical target volume (CTV) to planning target volume (PTV) margin reduction allowed by this technique. METHODS AND MATERIALS: Clips in the CBCT image are detected automatically using in-house software. The treatment couch is translated according to the shift in the clips' center of mass between the planning and CBCT images. Three components for the PTV margin are considered: (1) breathing, (2) surrogate error (i.e., error in cavity position after perfect setup to clips), and (3) residual error (i.e., error arising from the inability to execute a perfect setup to clips due to technological limitations, such as couch travel precision). These factors were input into a standard formula for CTV-to-PTV margin calculation. RESULTS: The average magnitude of clip-based corrections was 7 +/- 2 mm (10 patients, 44 fractions). After localization, the residual error magnitude was 1.6 +/- 1.3 mm, justifying an isotropic CTV-to-PTV margin of approximately 6 mm, including breathing and surrogate error. CONCLUSIONS: On-line localization of the lumpectomy cavity using surgical clips is technically feasible from the standpoint of equipment, time, and process, making possible a decreased CTV-to-PTV margin for accelerated partial breast irradiation. Because the procedure is exclusively target based, additional monitoring of critical structures may be advisable.

American Brachytherapy Society Task Group Report: Long-term control and toxicity with brachytherapy for localized breast cancer.

PURPOSE: There has been significant controversy regarding the equivalency of accelerated partial breast irradiation to whole-breast irradiation. With the recent publication of a large, randomized trial comparing these two treatment modalities, an update on the current state of knowledge of brachytherapy-based accelerated partial breast irradiation, with respect to local control and toxicities, would be useful to practitioners and patients. METHODS AND MATERIALS: A systematic literature review was conducted examining articles published between January 2000 and April 2016 on the topics "brachytherapy" and "breast." A total of 67 articles met inclusion criteria, providing outcomes on local tumor control and/or toxicity for breast brachytherapy. RESULTS: Reported 5-year local failure rates were 1.4-6.1% for multicatheter interstitial brachytherapy (MIB) and 0-5.7% for single-entry brachytherapy catheters when delivered to patients with standard selection criteria. Toxicity profiles are acceptable, with cosmetic outcomes comparable to whole-breast irradiation. The reported rates of infection were 0-12%. Symptomatic fat necrosis was found in 0-12% and 0-3.2% of patients treated with MIB and single-entry brachytherapy catheters, respectively. Late Grade ≥3 telangiectasias and fibrosis were reported in 0-8% and 0-9.1% of patients treated with MIB, respectively. These side effects were less common with single-entry brachytherapy catheters (0-2.0% and 0%, respectively). CONCLUSIONS: Breast brachytherapy is a treatment technique that provides acceptable rates of local control in select patients, as demonstrated by Level I evidence. The side effect profile of this treatment is well documented and should be shared with patients when considering this treatment modality.

Cone-beam-CT guided radiation therapy: A model for on-line application.

BACKGROUND AND PURPOSE: This paper presents efficient and generalized processes for the clinical application of on-line X-ray volumetric cone-beam CT imaging (XVI) to improve the accuracy of patient set-up in radiation therapy. XVI image-guided therapy is illustrated by application to two contrasting sites, intra-cranial radiosurgery and prostate radiation therapy, with very different characteristics regarding organ motion, treatment precision, and imaging conditions. PATIENTS AND METHODS: On-line set-up errors are determined in a two-step process. First the XVI data is registered to the planning data by matching the machine-isocenter with the planning-isocenter, respectively. The machine isocenter is defined in the XVI data during the reconstruction. The planning-isocenter is defined during the planning process in the planning CT data. Set-up errors are then determined from a second registration to remove residual displacements. The accuracy of the entire procedure for on-line set-up error correction was investigated in precision radiosurgery phantom studies. RESULTS: The phantom studies showed that sub-pixel size set-up errors (down to 0.5mm) can be correctly determined and implemented in the radiosurgery environment. XVI is demonstrated to provide quality skull detail enabling precise skull based on-line alignment in radiosurgery. A 'local XVI' technique was found to give encouraging soft-tissue detail in the high-scatter pelvic environment, enabling on-line soft-tissue based set-up for prostate treatment. The two-step process for determination of set-up errors was found to be efficient and effective when implemented with a dedicated six panel interface enabling simultaneous visualization on the XVI and planning CT data sets. CONCLUSIONS: XVI has potential to significantly improve the accuracy of radiation treatments. Present image quality is highly encouraging and can enable bony and soft-tissue patient set-up error determination and correction. As with all image guided treatment techniques the development of efficient procedures to utilize on-line data are of paramount importance.

Patterns of intrafractional motion and uncertainties of treatment setup reference systems in accelerated partial breast irradiation for right- and left-sided breast cancer.

PURPOSE: This study investigated the patterns of intrafractional motion and accuracy of treatment setup strategies in 3-dimensional conformal radiation therapy of accelerated partial breast irradiation (APBI) for right- and left-sided breast cancers. METHODS AND MATERIALS: Sixteen right-sided and 17 left-sided breast cancer patients were enrolled in an institutional APBI trial in which gold fiducial markers were strategically sutured to the surgical cavity walls. Daily pre- and postradiation therapy kV imaging were performed and were matched to digitally reconstructed radiographs based on bony anatomy and fiducial markers, respectively, to determine the intrafractional motion. The positioning differences of the laser-tattoo and the bony anatomy-based setups with respect to the marker-based setup (benchmark) were determined to evaluate their accuracy. RESULTS: Statistical differences were found between the right- and left-sided APBI treatments in vector directions of intrafractional motion and treatment setup errors in the reference systems, but less in their overall magnitudes. The directional difference was more pronounced in the lateral direction. It was found that the intrafractional motion and setup reference systems tended to deviate in the right direction for the right-sided breast treatments and in the left direction for the left-sided breast treatments. CONCLUSIONS: It appears that the fiducial markers placed in the seroma cavity exhibit side dependent directional intrafractional motion, although additional data may be needed to further validate the conclusion. The bony anatomy-based treatment setup improves the accuracy over laser-tattoo. But it is inadequate to rely on bony anatomy to assess intrafractional target motion in both magnitude and direction.

Technical note: contrast solution density and cross section errors in inhomogeneity-corrected dose calculation for breast balloon brachytherapy.

PURPOSE: Recent recommendations by the American Association of Physicists in Medicine Task Group 186 emphasize the importance of understanding material properties and their effect on inhomogeneity-corrected dose calculation for brachytherapy. Radiographic contrast is normally injected into breast brachytherapy balloons. In this study, the authors independently estimate properties of contrast solution that were expected to be incorrectly specified in a commercial brachytherapy dose calculation algorithm. METHODS: The mass density and atomic weight fractions of a clinical formulation of radiographic contrast solution were determined using manufacturers' data. The mass density was verified through measurement and compared with the density obtained by the treatment planning system's CT calibration. The atomic weight fractions were used to determine the photon interaction cross section of the contrast solution for a commercial high-dose-rate (HDR) brachytherapy source and compared with that of muscle. RESULTS: The density of contrast solution was 10% less than that obtained from the CT calibration. The cross section of the contrast solution for the HDR source was 1.2% greater than that of muscle. Both errors could be addressed by overriding the density of the contrast solution in the treatment planning system. CONCLUSIONS: The authors estimate the error in mass density and cross section parameters used by a commercial brachytherapy dose calculation algorithm for radiographic contrast used in a clinical breast brachytherapy practice. This approach is adaptable to other clinics seeking to evaluate dose calculation errors and determine appropriate density override values if desired.

A systematic approach to statistical analysis in dosimetry and patient-specific IMRT plan verification measurements.

PURPOSE: In the presence of random uncertainties, delivered radiation treatment doses in patient likely exhibit a statistical distribution. The expected dose and variance of this distribution are unknown and are most likely not equal to the planned value since the current treatment planning systems cannot exactly model and simulate treatment machine. Relevant clinical questions are 1) how to quantitatively estimate the expected delivered dose and extrapolate the expected dose to the treatment dose over a treatment course and 2) how to evaluate the treatment dose relative to the corresponding planned dose. This study is to present a systematic approach to address these questions and to apply this approach to patient-specific IMRT (PSIMRT) plan verifications. METHODS: The expected delivered dose in patient and variance are quantitatively estimated using Student T distribution and Chi Distribution, respectively, based on pre-treatment QA measurements. Relationships between the expected dose and the delivered dose over a treatment course and between the expected dose and the planned dose are quantified with mathematical formalisms. The requirement and evaluation of the pre-treatment QA measurement results are also quantitatively related to the desired treatment accuracy and to the to-be-delivered treatment course itself. The developed methodology was applied to PSIMRT plan verification procedures for both QA result evaluation and treatment quality estimation. RESULTS: Statistically, the pre-treatment QA measurement process was dictated not only by the corresponding plan but also by the delivered dose deviation, number of measurements, treatment fractionation, potential uncertainties during patient treatment, and desired treatment accuracy tolerance. For the PSIMRT QA procedures, in theory, more than one measurement had to be performed to evaluate whether the to-be-delivered treatment course would meet the desired dose coverage and treatment tolerance. CONCLUSION: By acknowledging and considering the statistical nature of multi-fractional delivery of radiation treatment, we have established a quantitative methodology to evaluate the PSIMRT QA results. Both the statistical parameters associated with the QA measurement procedure and treatment course need to be taken into account to evaluate the QA outcome and to determine whether the plan is acceptable and whether additional measures should be taken to reduce treatment uncertainties. The result from a single QA measurement without the appropriate statistical analysis can be misleading. When the required number of measurements is comparable to the planned number of fractions and the variance is unacceptably high, action must be taken to either modify the plan or adjust the beam delivery system.

Three-dimensional dosimetric considerations from different point A definitions in cervical cancer low-dose-rate brachytherapy.

PURPOSE: To investigate the dosimetric difference due to the different point A definitions in cervical cancer low-dose-rate (LDR) intracavitary brachytherapy. MATERIAL AND METHODS: Twenty CT-based LDR brachytherapy plans of 11 cervical patients were retrospectively reviewed. Two plans with point As following the modified Manchester system which defines point A being 2 cm superior to the cervical os along the tandem and 2 cm lateral (Aos), and the American Brachytherapy Society (ABS) guideline definition in which the point A is 2 cm superior to the vaginal fornices instead of os (Aovoid) were generated. Using the same source strength, two plans prescribed the same dose to Aos and Aovoid. Dosimetric differences between plans including point A dose rate, treatment volume encompassed by the prescription isodose line (TV), and dose rate of 2 cc of the rectum and bladder to the prescription dose were measured. RESULTS: On average Aovoid was 8.9 mm superior to Aos along the tandem direction with a standard deviation of 5.4 mm. With the same source strength and arrangement, Aos dose rate was 19% higher than Aovoid dose rate. The average TV(Aovoid) was 118.0 cc, which was 30% more than the average TV(Aos) of 93.0 cc. D2cc/D(Aprescribe) increased from 51% to 60% for rectum, and increased from 89% and 106% for bladder, if the prescription point changed from Aos to Aovoid. CONCLUSIONS: Different point A definitions lead to significant dose differences. Careful consideration should be given when changing practice from one point A definition to another, to ensure dosimetric and clinical equivalency from the previous clinical experiences.

Differences in effective target volume between various techniques of accelerated partial breast irradiation.

PURPOSE: Different cavity expansions are used to define the clinical target volume (CTV) for accelerated partial breast irradiation (APBI) delivered via balloon brachytherapy (1 cm) vs. three-dimensional conformal radiotherapy (3D-CRT) (1.5 cm). Previous studies have argued that the CTVs generated by these different margins are effectively equivalent. In this study, we use deformable registration to assess the effective CTV treated by balloon brachytherapy on clinically representative 3D-CRT planning images. METHODS AND MATERIALS: Ten patients previously treated with the MammoSite were studied. Each patient had two computed tomography (CT) scans, one acquired before and one after balloon implantation. In-house deformable registration software was used to deform the MammoSite CTV onto the balloonless CT set. The deformed CTV was validated using anatomical landmarks common to both CT scans. RESULTS: The effective CTV treated by the MammoSite was on average 7% ± 10% larger and 38% ± 4% smaller than 3D-CRT CTVs created using uniform expansions of 1 and 1.5 cm, respectively. The average effective CTV margin was 1.0 cm, the same as the actual MammoSite CTV margin. However, the effective CTV margin was nonuniform and could range from 5 to 15 mm in any given direction. Effective margins <1 cm were attributable to poor cavity-balloon conformance. Balloon size relative to the cavity did not significantly correlate with the effective margin. CONCLUSION: In this study, the 1.0-cm MammoSite CTV margin treated an effective volume that was significantly smaller than the 3D-CRT CTV based on a 1.5-cm margin.

Continuous arc rotation of the couch therapy for the delivery of accelerated partial breast irradiation: a treatment planning analysis.

PURPOSE: We present a novel form of arc therapy: continuous arc rotation of the couch (C-ARC) and compare its dosimetry with three-dimensional conformal radiotherapy (3D-CRT), intensity-modulated radiotherapy (IMRT), and volumetric-modulated arc therapy (VMAT) for accelerated partial breast irradiation (APBI). C-ARC, like VMAT, uses a modulated beam aperture and dose rate, but with the couch, not the gantry, rotating. METHODS AND MATERIALS: Twelve patients previously treated with APBI using 3D-CRT were replanned with (1) C-ARC, (2) IMRT, and (3) VMAT. C-ARC plans were designed with one medial and one lateral arc through which the couch rotated while the gantry was held stationary at a tangent angle. Target dose coverage was normalized to the 3D-CRT plan. Comparative endpoints were dose to normal breast tissue, lungs, and heart and monitor units prescribed. RESULTS: Compared with 3D-CRT, C-ARC, IMRT, and VMAT all significantly reduced the ipsilateral breast V50% by the same amount (mean, 7.8%). Only C-ARC and IMRT plans significantly reduced the contralateral breast maximum dose, the ipsilateral lung V5Gy, and the heart V5%. C-ARC used on average 40%, 30%, and 10% fewer monitor units compared with 3D-CRT, IMRT, and VMAT, respectively. CONCLUSIONS: C-ARC provides improved dosimetry and treatment efficiency, which should reduce the risks of toxicity and secondary malignancy. Its tangent geometry avoids irradiation of critical structures that is unavoidable using the en face geometry of VMAT.

Predictors of long-term toxicity using three-dimensional conformal external beam radiotherapy to deliver accelerated partial breast irradiation.

PURPOSE: We analyzed variables associated with long-term toxicity using three-dimensional conformal external beam radiation therapy (3D-CRT) to deliver accelerated partial breast irradiation. METHODS AND MATERIALS: One hundred patients treated with 3D-CRT accelerated partial breast irradiation were evaluated using Common Terminology Criteria for Adverse Events version 4.0 scale. Cosmesis was scored using Harvard criteria. Multiple dosimetric and volumetric parameters were analyzed for their association with worst and last (W/L) toxicity outcomes. RESULTS: Sixty-two patients had a minimum of 36 months of toxicity follow-up (median follow-up, 4.8 years). The W/L incidence of poor-fair cosmesis, any telangiectasia, and grade ≥2 induration, volume reduction, and pain were 16.4%/11.5%, 24.2%/14.5%, 16.1%/9.7%, 17.7%/12.9%, and 11.3%/3.2%, respectively. Only the incidence of any telangiectasia was found to be predicted by any dosimetric parameter, with the absolute breast volume receiving 5% to 50% of the prescription dose (192.5 cGy-1925 cGy) being significant. No associations with maximum dose, volumes of lumpectomy cavity, breast, modified planning target volume, and PTV, dose homogeneity index, number of fields, and photon energy used were identified with any of the aforementioned toxicities. Non-upper outer quadrant location was associated with grade ≥2 volume reduction (p = 0.02 W/p = 0.04 L). A small cavity-to-skin distance was associated with a grade ≥2 induration (p = 0.03 W/p = 0.01 L), a borderline significant association with grade ≥2 volume reduction (p = 0.06 W/p = 0.06 L) and poor-fair cosmesis (p = 0.08 W/p = 0.09 L), with threshold distances ranging from 5 to 8 mm. CONCLUSIONS: No dose--volume relationships associated with long-term toxicity were identified in this large patient cohort with extended follow-up. Cosmetic results were good-to-excellent in 88% of patients at 5 years.