Participating in an International Stereotactic Radiotherapy Patient Registry: The Establishment of Data Collection Pathways.
ABSTRACT: Aim To describe data collection pathways and practical challenges experienced by an academic comprehensive cancer centre aiming to record clinical data for patients being treated with a novel radiotherapy treatment modality. Methods Various options to capture data from all patients treated with the CyberKnife Robotic Radiosurgery System at Sir Charles Gairdner Hospital (SCGH) in Western Australia were explored. An international multicenter web-based secure database established and maintained by the Radiosurgery Society the RSSearch® Patient Registry was selected. Data were collected and entered over four contiguous phases, with either opt-in or opt-out consent and the completion of Patient Reported Outcome questionnaires for specific sub-groups. Results Between April 2014 and June 2016, 461 patients at Sir Charles Gairdner Hospital were enrolled in the RSSearch® Patient Registry with the collection of over 17,500 data items. From 461 patients enrolled, 447 patients were treated with the CyberKnife Robotic Radiosurgery System. The majority of patients were treated for either a malignant primary (43.2%) or metastatic disease (39.4%). The establishment of matrix organisational processes for data collection led to the development of improved workflow patterns and data collection pathways. Conclusions This article describes the processes developed by a single centre to establish an efficient system for data collection and participation in an international registry. The opt-out approach was more efficient in terms of patient recruitment compared to the informed-consent method used in earlier phases. The experience of this single centre may help inform other institutions considering data collection options for assessments of new or novel treatments.
Project description:CyberKnife is one of multiple modalities for stereotactic radiosurgery (SRS). Due to the nature of CyberKnife and the characteristics of SRS, dose evaluation of the CyberKnife procedure is critical. A radiophotoluminescent glass dosimeter was used to verify the dose accuracy for the CyberKnife procedure and validate a viable dose verification system for CyberKnife treatment. A radiophotoluminescent glass dosimeter, thermoluminescent dosimeter, and Kodak EDR2 film were used to measure the lateral dose profile and percent depth dose of CyberKnife. A Monte Carlo simulation for dose verification was performed using BEAMnrc to verify the measured results. This study also used a radiophotoluminescent glass dosimeter coupled with an anthropomorphic phantom to evaluate the accuracy of the dose given by CyberKnife. Measurements from the radiophotoluminescent glass dosimeter were compared with the results of a thermoluminescent dosimeter and EDR2 film, and the differences found were less than 5%. The radiophotoluminescent glass dosimeter has some advantages in terms of dose measurements over CyberKnife, such as repeatability, stability, and small effective size. These advantages make radiophotoluminescent glass dosimeters a potential candidate dosimeter for the CyberKnife procedure. This study concludes that radiophotoluminescent glass dosimeters are a promising and reliable dosimeter for CyberKnife dose verification with clinically acceptable accuracy within 5%.
Project description:Objectives Hypoglossal schwannomas are rare. Surgical resection has been the standard treatment modality. Radiosurgery has been increasingly used for treatment. Radiation-associated secondary malignancy/malignant transformation has not been documented in the literature for the treatment of nonvestibular schwannomas. Setting The patient was a 52-year-old man with an enlarging high cervical/skull base lesion 8.5 years after CyberKnife treatment of a presumed vagal schwannoma. A decision was made for surgical resection, and the tumor was found to originate from the hypoglossal nerve intraoperatively. Final pathology diagnosis was malignant peripheral nerve sheath tumor. Results Patient had a gross total resection. Three months after resection, he received fractionated radiation of 50 Gy in 25 fractions and a boost gamma knife radiosurgery of 10 Gy to the 50% isodose surface. He remained tumor free on repeat magnetic resonance imaging 9 months after the resection. Conclusion Although extremely rare, radiation treatment of nonvestibular schwannomas can potentially cause malignant transformation.
Project description:Objectives The purposes of this study are to assess the effectiveness of CyberKnife® stereotactic radiosurgery (SRS) in providing both initial and sustained pain relief for patients with both forms of trigeminal neuralgia (TN), assess potential prognostic factors, and examine treatment-related toxicities. Methods The RSSearch(®) Patient Registry was screened for TN cases from July 2007 to June 2015. We evaluated initial pain relief achieved by examining changes in the Visual Analog Scale (VAS) scores following SRS. Prognostic factors relating to initial pain relief and the relationship between maximum dose (Dmax) and toxicity incidence were analyzed via univariate logistic regressions. We evaluated prognostic factors relating to sustained pain relief using the Kaplan-Meier method and log-rank analysis. Results Our analysis included 125 TN1 patients and 38 TN2 patients with initial VAS scores ? 3 treated at 16 community radiotherapy centers. Median Dmax for both cohorts was 75 Gy with a larger range for TN1 cases (67.42 Gy - 110.29 Gy) as compared to TN2 cases (70.00 Gy - 78.48 Gy). At initial follow-up, mean VAS scores after SRS were significantly lower for TN1 and TN2 patients (p < 0.0001). The vast majority of TN1 (87.2%) and TN2 (86.8%) patients experienced initial pain relief. Higher initial VAS scores (p = 0.015) were correlated with a greater likelihood of initial treatment success for TN1 patients. We did not identify any treatment or patient characteristics that had significant effects on initial pain relief for TN2 patients. Of the TN1 cohort, 28 of 125 patients reported follow-ups one year or greater after SRS. Twenty-three of 28 TN1 patients (82%) reported VAS scores of 1 or less at one-year follow-up, and eight of 11 patients (72%) had VAS scores of 1 or less at the two-year follow-up. No potential prognostic factors for long-term pain relief were significant. Roughly 18% and 11% of TN1 and TN2 patients, respectively, experienced acute toxicities (all RTOG Grade 1 or 2), with the most common being sensory neuropathy, generalized pain, and nausea. Dmax > 75 Gy was not a predictor of toxicity incidence in TN1 cases (p = 0.597) but was significant for TN2 patients (p = 0.0009 following Fisher's exact test). Conclusions SRS is an effective treatment option for TN patients in community settings. Initial pain relief following SRS was achieved in a vast majority of TN patients with associated minor toxicities observed in less than 20% of all patients.
Project description:CyberKnife spinal radiosurgery suffers from a lack of posterior beams due to workspace limitations. This is remedied by a newly available tracking modality for fiducial-free, respiration-compensated spine tracking in prone patient position. We analyzed the potential dosimetric benefit in a planning study. Fourteen exemplary cases were compared in three scenarios: supine (PTV=CTV), prone (PTV=CTV), and prone position with an additional margin (PTV=CTV+2 mm), to incorporate reduced accuracy of respiration-compensated tracking. Target and spinal cord constraints were chosen according to RTOG 0631 protocol for spinal metastases. Plan quality was scored based on four predefined parameters: dose to cord (D0.1cc and D1cc), high dose (V10Gy), and low dose (V4Gy) volume of healthy tissue. Prescription dose was 16 Gy to the highest isodose line encompassing 90% of the target. Results were related to target size and position. All plans fulfilled RTOG 0631 constraints for coverage and dose to cord. When no additional margin was applied, a majority of eight cases benefitted from prone position, mainly due to a reduction of V4Gy by 23% ± 26%. In the 2 mm prone scenario, the benefit was nullified by an average increase of V10Gy by 43% ± 24%, and an increase of D1cc to cord (four cases). Spinal cord D0.1cc was unchanged (< ± 1 Gy) in all but two cases for both prone scenarios. Conformity (nCI) and number of beams were equivalent in all scenarios, but supine plans used a significantly higher number of monitor units (+16%) than prone. Posterior beam access can reduce dose to healthy tissue in CyberKnife spinal radiosurgery when no additional margin is applied. When a target margin of 2 mm is added, this potential gain is lost. Relative anterior-posterior position and size of the target are selection criteria for prone treatment.
Project description:This study compares the frequency and severity of influenza A/H1N1pdm09 (A/H1), influenza A/H3N2 (A/H3) and other respiratory virus infections in hospitalised patients. Data from 17 332 adult hospitalised patients admitted to Sir Charles Gairdner Hospital, Perth, Western Australia, with a respiratory illness between 2012 and 2015 were linked with data containing reverse transcription polymerase chain reaction results for respiratory viruses including A/H1, A/H3, influenza B, human metapneumovirus, respiratory syncytial virus and parainfluenza. Of these, 1753 (10.1%) had test results. Multivariable regression analyses were conducted to compare the viruses for clinical outcomes including ICU admission, ventilation, pneumonia, length of stay and death. Patients with A/H1 were more likely to experience severe outcomes such as ICU admission (OR 2.5, 95% CI 1.2-5.5, P = 0.016), pneumonia (OR 3.0, 95% CI 1.6-5.7, P < 0.001) and lower risk of discharge from hospital (indicating longer lengths of hospitalisation; HR 0.64 95% CI 0.47-0.88, P = 0.005), than patients with A/H3. Patients with a non-influenza respiratory virus were less likely to experience severe clinical outcomes than patients with A/H1, however, had similar likelihood when compared to patients with A/H3. Patients hospitalised with A/H1 had higher odds of severe outcomes than patients with A/H3 or other respiratory viruses. Knowledge of circulating influenza strains is important for healthcare preparedness.
Project description:The accuracy of radiation delivery is increasingly important as radiotherapy technology continues to develop. The goal of this study was to evaluate intrafractional motion during intracranial radiosurgery and the relationship between motion change and treatment time.A total of 50 treatment records with 5988 images, all acquired during treatments with the CyberKnife Radiosurgery System, were retrospectively analyzed in this study. We measured translation and rotation motion including superior-inferior (SI), right-left (RL), anterior-posterior (AP), roll, tilt and yaw. All of the data was obtained during the first 45 minutes of treatment. The records were divided into 3 groups based on 15-min time intervals following the beginning of treatment: group A (0-15 min), group B (16-30 min) and group C (31-45 min). The mean deviations, systematic errors, random errors and margin for planning target volume (PTV) were calculated for each group.The mean deviations were less than 0.1 mm in all three translation directions in the first 15 minutes. Greater motion occurred with longer treatment times, especially in the SI direction. For the 3D vector, a time-dependent change was observed, from 0.34 mm to 0.77 mm (p=0.01). There was no significant correlation between the treatment time and deviations in the AP, LR and rotation axes. Longer treatment times were associated with increases in systematic error, but not in random error. The estimated PTV margin for groups A, B and C were 0.86 / 1.14 / 1.31 mm, 0.75 / 1.12 / 1.20 mm, and 0.43 / 0.54 / 0.81 mm in the SI, RL, and AP directions, respectively.During intracranial radiosurgery, a consistent increase in the positioning deviation over time was observed, especially in the SI direction. If treatment time is greater than 15 minutes, we recommend increasing the PTV margins to ensure treatment precision.
Project description:Background and Aims: The Genomics Working Group (of the Cancer Research Network (CRN) Pharmacovigilance Project) explored single-site experiences with genomic studies to understand challenges and opportunities for collecting and using biological specimens. Its specific aims were to:Methods: We distributed a survey on existing biospecimen availability to principal investigators at all CRN Pharmacovigilance sites. Information collected included the number of specimens, storage methods, and type of specimens available. Investigators were also asked to identify past and current studies at their institutions in order to collect information on successful specimen collection strategies. A literature review was conducted both to identify potential barriers to participation and to understand the feasibility of various recruitment procedures. Benefits and limitations of ?opt-out? and ?opt-in? specimen collection methods were examined. Lastly, we developed study documents, including recruitment letters and informed consent forms, for future saliva and blood specimen collection efforts.Results: Two of the CRN HMOs currently have large-scale banked blood or saliva specimens (>20,000) within existing repositories. One site has two large-scale studies (>20,000 participants each) with banked specimens able to provide DNA for future research. Whole blood or blood components are the most commonly collected specimen types, and multiple CRN sites have access to banked tumor blocks. There were 33 past or current studies that included biospecimen collection. There was a trade-off between intensive data collection requirements and recruitment yield, cost, and participation burden.Conclusions: There is great potential for collection, storage, and use of biospecimen samples for research within the CRN. For future collection efforts, ?opt-out? models allow fast sample accrual, but impact data de-identification requirements. ?Opt-in? models allow for broad data collection, but are resource and time intensive. Pathology time and support may be a barrier to future use of stored samples.
Project description:BACKGROUND: Stereotactic radiosurgery (SRS) is a common treatment for recurrent or residual pituitary adenomas. The persistence of symptoms and treatment related complications may impair the patient's quality of life (QOL). PURPOSE: The purpose of this study was to examine symptom distress, QOL, and the relationship between them among patients with pituitary tumors who had undergone SRS. METHODS: This study used a cross-sectional design and purposive sampling. We enrolled patients diagnosed with pituitary tumors who had undergone SRS. Data were collected at the CyberKnife Center at a medical center in Northern Taiwan in 2012. A questionnaire survey was used for data collection. Our questionnaire consisted of 3 parts the Pituitary Tumor Symptom Distress Questionnaire, the World Health Organization Quality of Life Instrument Short-Form (WHOQOL-BREF), and a demographic questionnaire. RESULTS: Sixty patients were enrolled in the study. The most common symptoms reported by patients after SRS were memory loss, fatigue, blurred vision, headache, sleep problems, and altered libido. The highest and lowest scores for QOL were in the environmental and psychological domains, respectively. Age was positively correlated with general health and the psychological domains. Level of symptom distress was negatively correlated with overall QOL, general health, physical health, and the psychological and social relationships domains. The scores in the psychological and environmental domains were higher in males than in females. Patients with ≤6 symptoms had better overall QOL, general health, physical health, and psychological and social relationships than those with >6 symptoms. CONCLUSION: Symptom distress can affect different aspects of patient QOL. Levels of symptom distress, number of symptoms, age, and gender were variables significantly correlated with patient QOL. These results may be utilized by healthcare personnel to design educational and targeted interventional programs for symptom management to improve patient QOL.
Project description:BACKGROUND:Frameless, non-isocentric irradiation of an extended segment of the trigeminal nerve introduces new concepts in stereotactic radiosurgery for medically resistant trigeminal neuralgia (TN). OBJECTIVE:To report the results of the largest single-center experience about image-guided robotic radiosurgery for TN. METHODS:A cohort of 138 patients treated with CyberKnife® (Accuray Incorporated, Sunnyvale, California) radiosurgery with a minimum follow-up of 36 mo were recruited. Pain relief, medications, sensory disturbances, rate and time of pain recurrence were prospectively analyzed. RESULTS:Median follow-up was 52.4 mo; median dose 75 Gy; median target length 5.7-mm; median target volume 40 mm³; median prescription dose 60 Gy (80% isodose line). Actuarial pain control rate (Barrow Neurological Institute [BNI] class I-IIIa) at 6, 12, 24, and 36 mo were 93.5%, 85.8%, 79.7%, and 76%, respectively. Overall, 33 patients (24%) required a second treatment. Overall, 18.1% developed sensory disturbances after 16.4 ± 8.7 mo. One patient (0.7%) developed BNI grade IV dysfunction; 6 (4.3%) developed BNI grade III (somewhat bothersome) hypoesthesia after retreatment; BNI grade II (not bothersome) hypoesthesia was reported by 18 patients (11 after retreatment). Shorter nerve length (<6 mm vs 6 mm), smaller nerve volume (<30 mm3 vs >30 mm3), and lower prescription dose (<58 vs >58 Gy) were associated with treatment failure (P = .01, P = .02, P = .03, respectively). Re-irradiation independently predicted sensory disturbance (P < .001). CONCLUSION:Targeting a 6-mm segment of the trigeminal nerve with a prescribed dose of 60 Gy appears safe and effective. Persistent pain control was achieved in most patients with acceptable risk of sensory complications, which were typically found after re-irradiation.
Project description:This study was performed to examine the quality of planning and treatment modality using a CyberKnife (CK) robotic radiosurgery system with multileaf collimator (MLC)-based plans and IRIS (variable aperture collimator system)-based plans in relation to the dose-response of secondary cancer risk (SCR) in patients with benign intracranial tumors. The study population consisted of 15 patients with benign intracranial lesions after curative treatment using a CyberKnife M6 robotic radiosurgery system. Each patient had a single tumor with a median volume of 6.43 cm3 (range, 0.33-29.72 cm3). The IRIS-based plan quality and MLC-based plan quality were evaluated by comparing the dosimetric indices, taking into account the planning target volume (PTV) coverage, the conformity index (CI), and the dose gradient (R10% and R50%). The dose-response SCR with sarcoma/carcinoma induction was calculated using the concept of the organ equivalent dose (OED). Analyses of sarcoma/carcinoma induction were performed using excess absolute risk (EAR) and various OED models of dose-response type/lifetime attributable risk (LAR). Moreover, analyses were performed using the BEIR VII model. PTV coverage using both IRIS-based plans and MLC-based plans was identical, although the CI values obtained using the MLC-based plans showed greater statistical significance. In comparison with the IRIS-based plans, the MLC-based plans showed better dose falloff for R10% and R50% evaluation. The estimated difference between Schneider's model and BEIR VII in linear-no-threshold (Lnt) cumulative EAR was about twofold. The average values of LAR/EAR for carcinoma, for the IRIS-based plans, were 25% higher than those for the MLC-based plans using four SCR models; for sarcoma, they were 15% better in Schneider's SCR models. MLC-based plans showed slightly better conformity, dose gradients, and SCR reduction. There was a slight increase in SCR with IRIS-based plans in comparison with MLC-based plans. EAR analyses did not show any significant difference between PTV and brainstem analyses, regardless of the tumor volume. Nevertheless, an increase in target volume led to an increase in the probability of SCR. EAR showed statistically significant differences in the soft tissue according to tumor volume (1-10 cc and ≥10 cc).