Clinical Trials Radiographers identifying priority challenges associated with implementing a national programme of clinical trials in the United Kingdom's first proton beam therapy centre.

Objectives: This article is an evaluation of the current trial processes within a national proton beam therapy (PBT) clinical trial service in the United Kingdom. The work within the article identifies priority challenges associated with the implementation of PBT trials with a view to improving patient trial processes. Methods: The nominal group technique (NGT) was used. Five Clinical Trials Radiographers were asked the target question "what are the major challenges when implementing PBT clinical trials and facilitating PBT trial-related activities?" Participants individually and silently listed their challenges to the target question. Following this, group discussion clarified and refined responses. Participants then individually selected five challenges that they deemed most pertinent to the target question, giving a weighted score (out of 10). Individual scores were combined to provide a ranked, weighted order of challenges. Further group discussion identified improvement strategies to the highest scored challenges. Results: After combining lists generated by participants, 59 challenges were identified. Group discussion eliminated 27 responses. Eighteen were merged, resulting in 14 challenges. The two challenges that ranked highest were: (i) lack of initial understanding of the responsibilities of teams and who the relevant stakeholders were, and (ii) that a national PBT service requires the provision of shared care across multi-disciplinary teams and sites. Improvement areas include the development of shared protocols, clarifying stakeholder responsibilities and improving communication between centres to streamline PBT trial processes. Conclusions: This work has identified priority areas requiring development to improve the conduct of a national PBT clinical trials programme. Advances in knowledge: This is the first publication to evaluate current clinical trial processes for the United Kingdom's PBT service.

Impact of a contouring atlas on radiographer inter-observer variation in male pelvis radiotherapy.

PURPOSE/OBJECTIVE: To determine the impact of a MR-based contouring atlas for male pelvis radiotherapy delineation on inter-observer variation to support radiographer led real-time magnetic resonance image guided adaptive radiotherapy (MRgART). MATERIAL/METHODS: Eight RTTs contoured 25 MR images in the Monaco treatment planning system (Monaco 5.40.01), from 5 patients. The prostate, seminal vesicles, bladder, and rectum were delineated before and after the introduction of an atlas developed through multi-disciplinary consensus. Inter-observer contour variations (volume), time to contour and observer contouring confidence were determined at both time-points using a 5-point Likert scale. Descriptive statistics were used to analyse both continuous and categorical variables. Dice similarity coefficient (DSC), Dice-Jaccard coefficient (DJC) and Hausdorff distance were used to calculate similarity between observers. RESULTS: Although variation in volume definition decreased for all structures among all observers post intervention, the change was not statistically significant. DSC and DJC measurements remained consistent following the introduction of the atlas for all observers. The highest similarity was found in the bladder and prostate whilst the lowest was the seminal vesicles. The mean contouring time for all observers was reduced by 50% following the introduction of the atlas (53 to 27 minutes, p=0.01). For all structures across all observers, the mean contouring confidence increased significantly from 2.3 to 3.5 out of 5 (p=0.02). CONCLUSION: Although no significant improvements were observed in contour variation amongst observers, the introduction of the consensus-based contouring atlas improved contouring confidence and speed; key factors for a real-time RTT-led MRgART.

To see or not to see: Evaluation of magnetic resonance imaging sequences for use in MR Linac-based radiotherapy treatment.

BACKGROUND/PURPOSE: This work evaluated the suitability of MR derived sequences for use in online adaptive RT workflows on a 1.5 Tesla (T) MR-Linear Accelerator (MR Linac). MATERIALS/METHODS: Non-patient volunteers were recruited to an ethics approved MR Linac imaging study. Participants attended 1-3 imaging sessions in which a combination of DIXON, 2D and 3D volumetric T1 and T2 weighted images were acquired axially, with volunteers positioned using immobilisation devices typical for radiotherapy to the anatomical region being scanned. Images from each session were appraised by three independent reviewers to determine optimal sequences over six anatomical regions: head and neck, female and male pelvis, thorax (lung), thorax (breast/chest wall) and abdomen. Site specific anatomical structures were graded by the perceived ability to accurately contour a typical organ at risk. Each structure was independently graded on a 4-point Likert scale as 'Very Clear', 'Clear', 'Unclear' or 'Not visible' by observers, consisting of radiographers (therapeutic and diagnostic) and clinicians. RESULTS: From July 2019 to September 2019, 18 non-patient volunteers underwent 24 imaging sessions in the following anatomical regions: head and neck (n=3), male pelvis (n=4), female pelvis (n=5), lung/oesophagus (n=5) abdomen (n=4) and chest wall/breast (n=3). T2 sequences were the most preferred for perceived ability to contour anatomy in both male and female pelvis. For all other sites T1 weighted DIXON sequences were most favourable. CONCLUSION: This study has determined the preferential sequence selection for organ visualisation, as a pre-requisite to our institution adopting MR-guided radiotherapy for a more diverse range of disease sites.

The impact of an educational tool in cervix image registration across three imaging modalities.

OBJECTIVES: Accurate image registration is vital in cervical cancer where changes in both planning target volume (PTV) and organs at risk (OARs) can make decisions regarding image registration complicated. This work aims to determine the impact of a dedicated educational tool compared with experience gained in MR-guided radiotherapy (MRgRT). METHODS: 10 therapeutic radiographers acted as observers and were split into two groups based on previous experience with MRgRT and Monaco treatment planning system. Three CBCT-CT, three MR-CT and two MR-MR registrations were completed per patient by each observer. Observers recorded translations, time to complete image registration and confidence. Data were collected in two phases; prior to and following the introduction of a cervix registration guide. RESULTS: No statistically significant differences were noted between imaging modalities. Each group was assessed independently pre- and post-education, no statistically significant differences were noted in either CBCT-CT or MR-CT imaging. Group 1 MR-MR imaging showed a statistically significant reduction in interobserver variability (p=0.04), in Group 2, the result was not statistically significant (p=0.06). Statistically significant increases in confidence were seen in all three modalities (p≤0.05). CONCLUSIONS: At The Christie NHS Foundation Trust, radiographers consistently registered images across three different imaging modalities regardless of their previous experience. The implementation of an image registration guide had limited impact on inter- and intraobserver variability. Radiographers' confidence showed statistically significant improvements following the use of the registration manual. ADVANCES IN KNOWLEDGE: This work helps evaluate training methods for novel roles that are developing in MRgRT.

Development and results of a patient-reported treatment experience questionnaire on a 1.5 T MR-Linac.

INTRODUCTION: With the implementation of new radiotherapy technology, it is imperative that patient experience is investigated alongside efficacy and outcomes. This paper presents the development of a specifically designed validated questionnaire and a first report of international multi-institutional preliminary patient experience of MRI-guided adaptive radiotherapy (MRgART) on the 1.5 T MR-Linac (MRL). METHODS: A patient experience questionnaire was developed and validated before being distributed to the Elekta MRL Consortium, to gather first patient-reported experience from participating centres worldwide. The final version of the questionnaire contains 18 questions covering a range of themes and was scored on a Likert scale of 0-3. Responses were post-processed so that a score of 0 represents a negative response and 3 represents the most favourable response. These results were analysed for patient-reported experience of treatment on the MRL. Results were also analysed for internal consistency of the questionnaire using Chronbach's Alpha and the questionnaire contents were validated for relevance using content validity indexes (CVI). RESULTS: 170 responses were received from five centres, representing patients with a wide range of tumour treatment sites from four different countries. MRgART was well tolerated with an 84% favourable response across all questions and respondents. When analysed by theme, all reported the highest percentage of results in the favourable categories (2 and 3). Internal consistency in the questionnaire was high (Cronbach's α = 0.8) and the item-level CVI for each question was 0.78 or above and the Scale-level CVI was 0.93, representing relevant content. CONCLUSION: The developed questionnaire has been validated as relevant and appropriate for use in reporting experience of patients undergoing treatment on the MRL. The overall patient-reported experience and satisfaction from multiple centres within the Elekta MRL Consortium was consistently high. These results can reinforce user confidence in continuing to expand and develop MRL use in adaptive radiotherapy.

MRI and CBCT for lymph node identification and registration in patients with NSCLC undergoing radical radiotherapy.

PURPOSE: This study compared MRI to CBCT for the identification and registration of lymph nodes (LN) in patients with locally advanced (LA)-NSCLC, to assess the suitability of targeting LNs in future MR-image guided radiotherapy (MRgRT) workflows. METHOD: Radiotherapy radiographers carried out Visual Grading Analysis (VGA) assessment of image quality, LN registration and graded their confidence in registration for each of the 24 LNs on CBCT and two MR sequences, MR1 (T2w Turbo Spin Echo) and MR2 (T1w DIXON water only image). RESULTS: Pre-registration image quality assessment revealed MR1 and MR2 as significantly superior to CBCT in terms of image quality (p ≤ 0.01). No significant differences were noted in interobserver variability for LN registration between CBCT, MR1 and MR2. Observers were more confident in their MR registrations compared to their CBCT based LN registrations (p ≤ 0.02). SUMMARY: Interobserver setup correction variability was not found to be significantly different between CBCT and MR. Image quality and registration confidence were found to be superior for MRI sequences. This is a promising step towards MR-guided radiotherapy for the treatment of LA-NSCLC.

Therapeutic Radiographers at the Helm: Moving Towards Radiographer-Led MR-Guided Radiotherapy.

INTRODUCTION: Magnetic resonance-guided adaptive radiotherapy (MRgART) has the potential to improve treatment processes and outcomes for a variety of tumour sites; however, it requires significant clinical resources. Magnetic resonance linear accelerator (MR-linac) treatments require a daily multidisciplinary presence for delivery. To facilitate sustainable MRgART models, agreed protocols facilitating therapeutic radiographer (RTT)-led delivery must be developed to establish a service similar to conventional image-guided radiotherapy (IGRT). This work provides a clinical perspective on the implementation of a protocol-driven 'clinician-lite' MRgART workflow at one institution. METHODS: To identify knowledge, skills, and competence required at each step in the MRgART workflow, an interdisciplinary informal survey and needs assessment were undertaken to identify additional or enhanced skills required for MRgART, over and above those required for conventional cone-beam computed tomography-based IGRT. The MRgART pathway was critically evaluated by relevant professionals to encourage multidisciplinary input and discussion, allowing an iterative development of the RTT-led workflow. Starting with the simplest online adaptation strategy, consisting of a virtual couch shift and online replanning, clear guidelines were established for the delivery of radical prostate radiotherapy with a reduction in staff numbers present. RESULTS: The MRgART-specific skills identified included MRI safety and screening, MR image acquisition, MRI-based anatomy, multimodality image interpretation and registration, and treatment plan evaluation. These skills were developed in RTTs via tutorials, workshops, focussed self-directed reading, teaching of colleagues, and end-to-end workflow testing. After initial treatments and discussions, roles and responsibilities of the three professional groups (clinicians, RTTs, and physicists) have evolved to achieve a 'clinician-lite' workflow for simple radical prostate treatments. DISCUSSION: Through applying a definitive framework and establishing agreed threshold and action levels for action within anticipated treatment scenarios similar to those in cone-beam computed tomography-based IGRT, we have implemented a 'clinician-lite' workflow for simple adaptive treatments on the MR-linac. The responsibility for online plan evaluation and approval now rests with physicists and RTTs to streamline MRgART. Early evaluation of the framework after treatment of 10 patients has required minimal online clinician input (1.5% of 200 fractions delivered). CONCLUSION: A 'clinician-lite' prostate treatment workflow has been successfully introduced on the MR-linac at our institution and will serve as a model for other tumour sites, using more complex adaptive strategies. Early indications are that this framework has the potential to improve patient throughput and efficiency. Further identification and validation of roles and responsibilities such as online contouring, and more interactive online planning, will facilitate RTTs to fully lead in the online workflow as adaptive radiotherapy becomes ever more complex.

Comparison of radiographer interobserver image registration variability using cone beam CT and MR for cervix radiotherapy.

OBJECTIVES: The aim of this study was to assess the consistency of therapy radiographers performing image registration using cone beam computed tomography (CBCT)-CT, magnetic resonance (MR)-CT, and MR-MR image guidance for cervix cancer radiotherapy and to assess that MR-based image guidance is not inferior to CBCT standard practice. METHODS: 10 patients receiving cervix radiation therapy underwent daily CBCT guidance and magnetic resonance (MR) imaging weekly during treatment. Offline registration of each MR image, and corresponding CBCT, to planning CT was performed by five radiographers. MR images were also registered to the earliest MR interobserver variation was assessed using modified Bland-Altman analysis with clinically acceptable 95% limits of agreement (LoA) defined as ±5.0 mm. RESULTS: 30 CBCT-CT, 30 MR-CT and 20 MR-MR registrations were performed by each observer. Registration variations between CBCT-CT and MR-CT were minor and both strategies resulted in 95% LoA over the clinical threshold in the anteroposterior direction (CBCT-CT ±5.8 mm, MR-CT ±5.4 mm). MR-MR registrations achieved a significantly improved 95% LoA in the anteroposterior direction (±4.3 mm). All strategies demonstrated similar results in lateral and longitudinal directions. CONCLUSION: The magnitude of interobserver variations between CBCT-CT and MR-CT were similar, confirming that MR-CT radiotherapy workflows are comparable to CBCT-CT image-guided radiotherapy. Our results suggest MR-MR radiotherapy workflows may be a superior registration strategy. ADVANCES IN KNOWLEDGE: This is the first publication quantifying interobserver registration of multimodality image registration strategies for cervix radical radiotherapy patients.