Percutaneous vertebroplasty under local anaesthesia: feasibility regarding patients' experience.

OBJECTIVE: Evaluate patients' intraoperative experience of percutaneous vertebroplasty (PV) performed without general anaesthesia in order to assess the feasibility of local anaesthesia and simple analgesic medication as pain control protocol. METHODS: Ninety-five patients who underwent single-site PV were consecutively included in the study between 2011 and 2013. Each procedure was achieved under local anaesthesia and perfusion of paracetamol, tramadol and dolasetron, with combined CT and fluoroscopy guidance. Numeric pain scale (NPS) was collected before, during and after intervention. After intervention, patients were asked to evaluate their experience as "very bad", "bad", "fair", "good" or "very good", independently of the pain. RESULTS: Indications for vertebroplasty were osteopenic fractures (78 %), aggressive angiomas (13 %) and somatic tumours (9 %). In 76 % of cases, patients' experience was described as "very good" (44 %) or "good" (32 %), whereas 19 % described it as "fair" and 5 % as "very bad". Mean operative NPS was 5.5. After intervention, NPS was significantly lower with a decrease of 4.5 points. No differences were found according to the localization, type of lesion, age or sex either in terms of experience or NPS. CONCLUSION: Percutaneous vertebroplasty is feasible under local anaesthesia alone, with a very good or good experience in 76 % of the patients. KEY POINTS: • Vertebroplasty is a first-line therapy for consolidation and pain control of vertebral lesions. • This procedure is commonly performed under general anaesthesia or conscious sedation. • We perform vertebroplasty under local anaesthesia and simple analgesic protocol with acceptable experience. • Percutaneous vertebroplasty can safely be proposed in a fragile population.

Evaluation of a cloud-based local-read paradigm for imaging evaluations in oncology clinical trials for lung cancer.

BACKGROUND: Although tumor response evaluated with radiological imaging is frequently used as a primary endpoint in clinical trials, it is difficult to obtain precise results because of inter- and intra-observer differences. PURPOSE: To evaluate usefulness of a cloud-based local-read paradigm implementing software solutions that standardize imaging evaluations among international investigator sites for clinical trials of lung cancer. MATERIAL AND METHODS: Two studies were performed: KUMO I and KUMO I Extension. KUMO I was a pilot study aiming at demonstrating the feasibility of cloud implementation and identifying issues regarding variability of evaluations among sites. Chest CT scans at three time-points from baseline to progression, from 10 patients with lung cancer who were treated with EGFR tyrosine kinase inhibitors, were evaluated independently by two oncologists (Japan) and one radiologist (France), through a cloud-based software solution. The KUMO I Extension was performed based on the results of KUMO I. RESULTS: KUMO I showed discordance rates of 40% for target lesion selection, 70% for overall response at the first time-point, and 60% for overall response at the second time-point. Since the main reason for the discordance was differences in the selection of target lesions, KUMO I Extension added a cloud-based quality control service to achieve a consensus on the selection of target lesions, resulting in an improved rate of agreement of response evaluations. CONCLUSION: The study shows the feasibility of imaging evaluations at investigator sites, based on cloud services for clinical studies involving multiple international sites. This system offers a step forward in standardizing evaluations of images among widely dispersed sites.

Volume-based response evaluation with consensual lesion selection: a pilot study by using cloud solutions and comparison to RECIST 1.1.

RATIONALE AND OBJECTIVES: Lesion volume is considered as a promising alternative to Response Evaluation Criteria in Solid Tumors (RECIST) to make tumor measurements more accurate and consistent, which would enable an earlier detection of temporal changes. In this article, we report the results of a pilot study aiming at evaluating the effects of a consensual lesion selection on volume-based response (VBR) assessments. MATERIALS AND METHODS: Eleven patients with lung computed tomography scans acquired at three time points were selected from Reference Image Database to Evaluate Response to therapy in lung cancer (RIDER) and proprietary databases. Images were analyzed according to RECIST 1.1 and VBR criteria by three readers working in different geographic locations. Cloud solutions were used to connect readers and carry out a consensus process on the selection of lesions used for computing response. Because there are not currently accepted thresholds for computing VBR, we have applied a set of thresholds based on measurement variability (-35% and +55%). The benefit of this consensus was measured in terms of multiobserver agreement by using Fleiss kappa (κfleiss) and corresponding standard errors (SE). RESULTS: VBR after consensual selection of target lesions allowed to obtain κfleiss = 0.85 (SE = 0.091), which increases up to 0.95 (SE = 0.092), if an extra consensus on new lesions is added. As a reference, the agreement when applying RECIST without consensus was κfleiss = 0.72 (SE = 0.088). These differences were found to be statistically significant according to a z-test. CONCLUSIONS: An agreement on the selection of lesions allows reducing the inter-reader variability when computing VBR. Cloud solutions showed to be an interesting and feasible strategy for standardizing response evaluations, reducing variability, and increasing consistency of results in multicenter clinical trials.