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Purpose: Renovation of the brachytherapy program at a leading cancer center utilized methods of the AAPM TG-100 report to objectively evaluate current clinical brachytherapy workflows and develop techniques for minimizing the risk of failures, increasing efficiency, and consequently providing opportunities for improved treatment quality. The TG-100 report guides evaluation of clinical workflows with recommendations for identifying potential failure modes (FM) and scoring them from the perspective of their occurrence frequency O, failure severity S, and inability to detect them D. The current study assessed the impact of differing methods to determine the risk priority number (RPN) beyond simple multiplication., Methods and Materials: The clinical workflow for a complex brachytherapy procedure was evaluated by a team of 15 staff members, who identified discrete FM using alternate scoring scales than those presented in the TG-100 report. These scales were expanded over all clinically relevant possibilities with care to emphasize mitigation of natural bias for scoring near the median range as well as to enhance the overall scoring-system sensitivity. Based on staff member perceptions, a more realistic measure of risk was determined using weighted functions of their scores., Results: This new method expanded the range of RPN possibilities by a factor of 86, improving evaluation and recognition of safe and efficient clinical workflows. Mean RPN values for each FM decreased by 44% when changing from the old to the new clinical workflow, as evaluated using the TG-100 method. This decreased by 66% when evaluated with the new method. As a measure of the total risk associated with an entire clinical workflow, the integral of RPN values increased by 15% and decreased by 31% with the TG-100 and new methods, respectively., Conclusions: This appears to be the first application of an alternate approach to the TG-100 method for evaluating the risk of clinical workflows. It exemplifies the risk analysis techniques necessary to rapidly evaluate simple clinical workflows appropriately., (Copyright © 2021 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: The noninvasive image-guided breast brachytherapy (NIBB) technique is a novel noninvasive yet targeted method for accelerated partial breast irradiation. We established a multi-institutional registry to evaluate the toxicity and efficacy of this technique across various practice settings., Methods and Materials: Institutions using the NIBB technique were invited to participate. Data for acute/late toxicity, cosmetic outcome, and tumor recurrence were collected. Toxicity and cosmetic outcome were graded based on the Common Terminology Criteria for Adverse Events version 3.0 and NRG/Radiation Therapy Oncology Group scale, respectively. Treatment variables were analyzed for association with outcomes., Results: A total of 252 patients from eight institutions were analyzed. The median age was 69 years. The mean tumor size was 1.1 cm (0.1-4.0 cm). Treatment was delivered 10 fractions (34-36 Gy) in 75% and five fractions (28.5 Gy) in 22%. B.i.d. fractionation was used in 9%. Acute radiation dermatitis was Grade 0-1, 2, and 3 in 77%, 19%, and 4%, respectively. One hundred ninety-one patients with a median followup of 18 months (4-72 months) were evaluable for late outcomes. Late toxicity Grades 2 and 3 were observed in 8.8% and 1%, respectively. Cosmetic outcome was excellent, good, and fair/poor in 62%, 36%, and 2%, respectively. B.i.d. fractionation was associated with higher acute and late toxicity. Second-generation applicators were associated with lower late toxicity and better cosmetic outcome. Actuarial freedom from ipsilateral breast tumor recurrence and true recurrence were 98.3% and 98.3% at 2 years and 90.9% and 95.4% at 5 years, respectively., Conclusions: Accelerated partial breast irradiation using NIBB was well tolerated with a low rate of acute and late toxicity across various practice settings. Ipsilateral breast tumor recurrence and cosmetic outcomes were favorable. b.i.d. fractionation was associated with higher toxicity. Longer followup is needed to confirm late endpoints., (Copyright © 2021 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Mammographically based noninvasive image-guided breast brachytherapy (NIBB) partial breast irradiation (PBI) is ideally suited for preoperative treatment. We hypothesize that delivering NIBB PBI to the preoperative tumor volume compared with the postoperative lumpectomy bed would simplify target identification and allow for a reduction in irradiated volume along each orthogonal axis., Methods and Materials: Patients with invasive breast cancer treated with NIBB PBI at our institution were identified. Preoperative NIBB treatments were modeled along orthogonal craniocaudal and mediolateral axes with an applicator encompassing the gross lesion plus a 1 cm clinical target volume margin. Preoperative treatment volumes were calculated along each axis using the selected applicator surface area multiplied by the preoperative mammogram separation. The actual applicator size and breast separation from the first fraction of postoperative treatment was used to calculate the postoperative treatment volume. Paired -test was used to compare the preoperative and postoperative treatment separation, area, and volume for each patient., Results: Forty-eight patients with Stage I-II breast cancer had imaging and treatment data available for review. Along the axis, the mean preoperative treatment volume was significantly less than the mean postoperative treatment volume (116 cm 3 vs. 204 cm 3 , respectively; p < 0.0001). Similarly, along the mediolateral axis, the mean preoperative treatment volume was significantly less than the mean postoperative treatment volume (125 cm 3 vs. 216 cm 3 , respectively; p < 0001)., Conclusions: Based on our retrospective comparison, PBI delivered using NIBB to the preoperative tumor may reduce the volume of healthy breast tissue receiving radiation as compared with NIBB to the postoperative tumor bed., (Copyright © 2020 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: While the noninvasive breast brachytherapy (NIBB) treatment procedure, known as AccuBoost, for breast cancer patients is well established, the treatment quality can be improved by the efficiency of the workflow delivery. A formalized approach evaluated the current workflow through failure modes and effects analysis and generated insight for developing new procedural workflow techniques to improve the clinical treatment process., Methods and Materials: AccuBoost treatments were observed for several months while gathering details on the multidisciplinary workflow. A list of possible failure modes for each procedure step was generated and organized by timing within the treatment process. A team of medical professionals highlighted procedural steps that unnecessarily increased treatment time, as well as introduced quality deficiencies involving applicator setup, treatment planning, and quality control checks preceding brachytherapy delivery. Procedural improvements and their impact on the clinical workflow are discussed., Results: The revised clinical workflow included the following key procedural enhancements. Prepatient arrival: Improvement of prearrival preparation requires advance completion of dose calculation documentation with patient-specific setup data. Patient arrival pretreatment: Physicists carry out dwell time calculations and check the plan, while the therapist concurrently performs several checks of the ensuing hardware configuration., Treatment: An electronic method to export the associated HDR brachytherapy paperwork to the electronic medical record system with electronic signatures and captured approvals was generated. Posttreatment: The therapist confirms the applicators were appropriately positioned, and treatment was delivered as expected., Conclusions: The procedural improvements reduced the overall treatment time, improved consistency across users, and eased performance of this special procedure for all participants., (Copyright © 2020 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To improve efficiency, convenience, and cost, a prospective phase II trial was initiated to evaluate accelerated partial breast irradiation delivered with noninvasive image-guided breast brachytherapy (NIBB) via five once-daily fractions., Methods and Materials: Women ≥50 years old with early-stage breast cancer undergoing breast conserving surgery were enrolled. Eligibility criteria included invasive carcinoma ≤2.0 cm or ductal carcinoma in situ ≤3.0 cm, ER positive (if invasive), lymph node negative, LVI absent, and margins negative by 2 mm. Patients received a total dose of 28.5 Gy in five daily fractions. NIBB was delivered using two orthogonal axes for each fraction. Applicators were selected to encompass the lumpectomy cavity with a 1.0 cm clinical target volume margin and 0 to 0.5 cm planning target volume margin. Acute and late toxicity was assessed based on CTCAE v3.0., Results: Forty patients with a mean age of 67 years underwent protocol treatment. Mean tumor size was 1.0 cm (0.3-2.0 cm). Eighty percent had invasive carcinoma and the remainder had ductal carcinoma in situ. Mean tumor bed volume was 21 cc (5-79 cc) and mean breast volume was 1319 cc (499-3044 cc). Mean breast separation with compression was 6.7 cm (3.5-8.9 cm). All patients tolerated well. Median discomfort with compression was 1 (range: 0-7) on a 10-point pain scale. Acute skin reaction was Grade 0-1 in 70%, Grade 2 in 28%, and Grade 3 in 3%. Acute skin toxicity was not associated with breast size but was associated with larger breast separation with compression (p < 0.01) and larger applicator size (p < 0.01). No Grade 3+ late toxicity or local recurrences have been observed at a median followup of 14 months., Conclusions: Accelerated partial breast irradiation delivered using NIBB over five daily fractions is a convenient treatment option that is feasible and well tolerated., (Copyright © 2018 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: We examined the radiotherapy patterns of care over an 8-year period during which the PORTEC-2 trial and other series were published., Methods and Materials: Patients diagnosed with Stage I endometrioid adenocarcinoma (EA) between 2004 and 2011 were identified in the National Cancer Institute's Surveillance, Epidemiology, and End Results database. Adjuvant radiation treatments were analyzed by year. Patterns of care from 2004 to 2008 were compared to those from 2009 to 2011 using the χ 2 test., Results: Analysis included 31,688 patients with Stage I EA. Among those diagnosed in 2004, 9.3% received adjuvant external beam radiotherapy (EBRT) and 5.0% received adjuvant brachytherapy. In 2011, 4.5% received EBRT and 9.3% received brachytherapy. In those diagnosed with high-intermediate risk (H-IR) EA in 2004, 58.8% received no adjuvant treatment, 28.3% received EBRT, and 12.9% received brachytherapy. In 2011, 57.8% of patients with H-IR disease received no adjuvant treatment, 14.3% received EBRT, and 27.9% received brachytherapy. There was a significant difference in the proportion of patients with H-IR EA treated with EBRT vs. brachytherapy alone before and after 2008 (p < 0.0001) with an increase in use of brachytherapy and a decrease in the use of EBRT., Conclusions: The use of brachytherapy alone after hysterectomy has increased over time in all women with Stage I EA and in those with H-IR disease. In almost all subsets, the proportion of women being treated with brachytherapy increased and the proportion treated with EBRT decreased. Less than 30% received adjuvant brachytherapy and over 50% of women were treated without adjuvant radiotherapy., (Copyright © 2016 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) is an attractive novel approach to deliver accelerated partial breast irradiation (APBI). Calculations of equivalent uniform dose (EUD) were performed to identify the appropriate APBI dose for this technique., Methods and Materials: APBI plans were developed for 15 patients: five with three-dimensional conformal APBI (3D-CRT), five with multi-lumen intracavitary balloons (m-IBB), and five simulating NIBB treatment. Prescription doses of 34.0 and 38.5 Gy were delivered in 10 fractions for m-IBB and 3D-CRT, respectively. Prescription doses ranging from 34.0 to 38.5 Gy were considered for NIBB. Dose-volume histogram data from all 3D-CRT, m-IBB, and NIBB plans were used to calculate the biologically effective EUD and corresponding EUD to the PTV&#95;eval using the following equation: EUD = EUBED/(n [1 + EUD/α/β]). An α/β value of 4.6 Gy was assumed for breast tumor. EUD for varying NIBB prescription doses were compared with EUD values for the other APBI techniques., Results: Mean PTV&#95;eval volume was largest for 3D-CRT (372.9 cm(3)) and was similar for NIBB and m-IBB (88.7 and 87.2 cm(3), respectively). The EUD value obtained by prescribing 38.5 Gy with 3D-CRT APBI was 38.6 Gy. The EUD value of 34.0 Gy prescribed with m-IBB was 34.4 Gy. EUD values for NIBB ranged from 33.9 to 38.2 Gy for prescription doses ranging from 34.0 to 38.5 Gy., Conclusions: Using EUD calculations to compare APBI techniques and treatment doses, a prescription dose of 36.0 Gy in 10 fractions using NIBB has a comparable biologic equivalent dose to other established brachytherapy techniques., (Copyright © 2015 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) allows for accurate targeting of the tumor bed (TB) for breast boost by using breast immobilization and image guidance. However, not all patients are candidates for this technique., Methods: Consecutive patients treated for breast cancer were evaluated. Patients with very small breast size (cup ≤ A) for whom immobilization could not be achieved were treated with electrons. All others underwent simulation for NIBB boost. The rate of eligibility for NIBB, reasons for ineligibility, and related patient and anatomic factors were analyzed., Results: Of 52 patients evaluated, 6 patients were ineligible for NIBB because of small breast size. Of the remaining patients who underwent simulation for NIBB boost, 33 patients (72%) were treated with NIBB. Reasons for ineligibility were the absence of identifiable TB (n = 5), inability to position patient/breast to adequately target the TB (n = 4), posterior TB location (n = 3), and discomfort during compression (n = 1). The likelihood of being eligible for NIBB boost was dependent on breast size: ≤A (0%), B (50%), C (71%), D-DD (77%), and >DD (80%) (p = 0.002). The presence of surgical clips also predicted eligibility for NIBB: 79% clips vs. 45% without clips (p = 0.05). A posterior TB location was not associated with ineligibility (p = 0.2)., Conclusions: NIBB boost is feasible in most patients. Patients with larger breast size are more likely to be good candidates. Posterior TB location can be challenging for NIBB, but most patients are still candidates. Surgical clips are very helpful in defining the TB and greatly increase the likelihood of eligibility for NIBB., (Copyright © 2014 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: Noninvasive image-guided breast brachytherapy (NIBB) is a novel approach to deliver accelerated partial breast irradiation (APBI). NIBB is noninvasive, yet maintains a high degree of precision by using breast immobilization and image guidance. This makes NIBB an attractive alternative to existing APBI techniques., Methods and Materials: Forty patients were enrolled to an institutional review board-approved prospective clinical trial evaluating APBI using NIBB. The NIBB technique is described in detail. Briefly, patients were treated with the breast compressed and immobilized sequentially in two orthogonal axes for each fraction. Radiation was delivered using collimated emissions from a high-dose-rate iridium-192 source via specialized applicators. The prescribed dose was 34.0 Gy in 10 fractions. Feasibility and tolerability of treatment were assessed., Results: All patients completed protocol treatment. The median age was 68 years. Sixty-three percent of patients had invasive carcinoma, and 37% had ductal carcinoma in situ. All were node negative. Ninety-three percent of patients were postmenopausal. Mean tumor size, tumor bed volume, and breast volume were 1.1 cm, 22.4 cc, and 1591 cc, respectively. NIBB treatment was well tolerated. Median patient-reported discomfort was 1 on a 10-point pain scale. Treatment delivery times were reasonable. The average treatment time per axis was 14 min (5-20 min), and the average time from start of first treatment axis to completion of orthogonal axis was 43 min (30-63 min). Acute skin toxicity was Grade 0, 1, and 2 in 20%, 53%, and 28% of patients, respectively. There were no Grade 3 or greater acute toxicities observed., Conclusions: NIBB holds promise as an alternative method to deliver APBI. NIBB is feasible and well tolerated by patients. Further investigation of NIBB to deliver APBI is warranted., (Copyright © 2014 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To compare overall survival, local and distant failure rates, ocular toxicity, and vision preservation in patients treated with eye plaque brachytherapy at Tufts Medical Center with those in the published literature., Methods and Materials: Records were reviewed for 53 patients with the diagnosis of uveal melanoma treated with plaque brachytherapy at Tufts Medical Center over the past 17 years. American Joint Committee on Cancer staging (T1, T2, or T3) were 4, 39, and 10 patients, respectively. All the patients were treated using (125)I (n=37), (103)Pd (n=5), or (131)Cs (n=11) to a dose of 85Gy (documented as 100Gy before 1996 for the same physical dose)., Results: With a mean followup of 75 months, 38 of 53 patients were still alive. Five patients (all (125)I) developed liver metastases (9%) with no evidence of local failure. There were 10 definitive local failures and four additional transpupillary thermo-therapy procedures performed to ensure local control for lesions slow to respond. Twelve patients (23%) required enucleation. At most recent followup, 32 patients (71%) maintained 20/200 vision or better in the treated eye. In this first report of (131)Cs plaque therapy with a mean followup of 20 months, there were two transpupillary thermo-therapy procedures and one definitive failure requiring enucleation after 10 months., Conclusions: Our disease control and ocular results were comparable to those in the literature given the extended followup. We are developing a multi-institutional, prospective clinical protocol for considering radionuclide selection and other prescriptive criteria., (Copyright © 2011 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)

Purpose: To describe a novel source-delivery system for intraoperative brachytherapy in patients with early-stage lung cancer that is readily adaptable to a video-assisted thoracoscopic surgery approach and can be precisely delivered to achieve optimal dose distribution., Methods and Materials: Radioactive ytterbium-169 ((169)Yb) was sealed within a titanium tube 0.28 mm in diameter and then capped and resealed by titanium wires laser welded to the tube to serve as the legs of a tissue-fastening system. Dose simulations were performed using Monte Carlo computer code (Los Alamos National Laboratory, Los Alamos, NM) to mimic the geometric and elemental compositions of the source, fastening apparatus, and surroundings., Results: Five test source capsules were subjected to a tensile load to failure. Failure in each capsule occurred in the wire of the fastener leg; there were no weld failures. Monte Carlo simulations and subsequent dose measurement showed the perturbation by the source legs in the deployed (bent over) position to be small (4-5%) for (169)Yb and much less than that for iodine-125 (32%)., Conclusion: We have developed a (169)Yb brachytherapy source-delivery system that can be used in conjunction with commercially available surgical stapling instruments, facilitates the precise placement of brachytherapy sources relative to the surgical margin, assures the seeds remain fixed in their precise position for the duration of the treatment, overcomes the technical difficulties of manipulating the seeds through the narrow surgical incision associated with video-assisted thoracoscopic surgery, and reduces the radiation dose to the clinicians., (Copyright © 2011 American Brachytherapy Society. Published by Elsevier Inc. All rights reserved.)