scholarly journals BioXmark® liquid fiducial markers for image-guided radiotherapy in muscle invasive bladder cancer: a safety and performance trial

2020 ◽  
Vol 93 (1111) ◽  
pp. 20200241
Author(s):  
Mischa de Ridder ◽  
Lara C Gerbrandy ◽  
Theo M de Reijke ◽  
Karel A Hinnen ◽  
Maarten C.C.M. Hulshof

Objective: This study evaluated the performance of the novel liquid fiducial marker (BioXmark®) in IGRT for bladder cancer. Methods: 20 patients with muscle invasive bladder cancer were entered in this prospective, single center, Phase I-II study. The novel BioXmark® liquid markers were injected around the tumor using a flexible cystoscopy. Visibility and stability of the markers were evaluated on planning-CT and CBCT. Prospectively defined threshold for success was set at a visibility of 75%. Results: In total, 76 markers were implanted in 20 patients. Of those, 60 (79% 95% CI ± 9%) were visible on CT scan. Due to the learning curve of the technique, the visibility improved in the last 75% of patients (86% visibility) compared to the first 25% of patients with 58% visibility. Concerning stability of the BioXmark® marker, all visible markers after CT acquisition were still detectable at the last CBCT without displacement. In 15/20 (75%) of the patients, three or more markers were visible on CT. No BioXmark® related adverse events were reported. Conclusion: The success rate of this novel fiducial marker was 79%, which is above the prospectively defined threshold rate. A distinct learning curve of the injection of the liquid marker was seen over the study period. The marker showed sustained visibility and positional stability during treatment phases and also appears to be safe and easy to inject. Advances in knowledge: This novel liquid BioXmark® marker seems to be a very promising tool in daily-adaptive IGRT for bladder preserving chemoradiotherapy in muscle invasive bladder cancer.

2021 ◽  
Vol 10 (24) ◽  
pp. 5969
Author(s):  
Riccardo Lombardo ◽  
Riccardo Mastroianni ◽  
Gabriele Tuderti ◽  
Mariaconsiglia Ferriero ◽  
Aldo Brassetti ◽  
...  

(1) Aim: Robot assisted radical cystectomy (RARC) with intacorporeal neobladder (iN) is a challenging procedure. There is a paucity of reports on RARC-iN, the extracorporeal approach being the most used. The aim of our study was to assess the learning curve of RARC-iN and to test its performance in benchmarking Pasadena consensus outcomes. (2) Material and methods: The single-institution learning curve of RARC-iN was retrospectively evaluated. Demographic, clinical and pathologic data of all patients were recorded. Indications to radical cystectomy included muscle invasive bladder cancer (pT ≥ 2) or recurrent high grade non muscle invasive bladder cancer. The cumulative sum (CUSUM) technique, one of the methods developed to monitor the performance and quality of the industrial sector, was adopted by the medical field in the 1970s to analyze learning curves for surgical procedures. The learning curve was evaluated using the following criteria: 1. operative time (OT) <5 h; 2. 24-h Hemoglobin (Hb) drop <2 g/dl; 3. severe complications (according to the Clavien classification system) <30%; 4. positive surgical margins <5%; and 5. complete lymph-node dissection defined as more than 16 nodes. Benchmarking of all five items on quintile analysis was tested, and a failure rate <20% for any outcome was set as threshold. (3) Results: the first 100 consecutive RARC-iN patients were included in the analysis. At CUSUM analysis, RARC required 20 cases to achieve a plateau in terms of operative time (defined as more than 3 consecutive procedures below 300 min). Hemoglobin drop, PSM and number of removed lymph-nodes did not change significantly along the learning curve. Overall, 41% of the patients presented at least one complication. Low-grade and high-grade complication rates were 30% and 17%, respectively. When assessing the benchmarks of all five Pasadena consensus outcomes on quintile analysis, a plateau was achieved after the first 60 cases. (4) Conclusions: RARC-iN is a challenging procedure. The potential impact of the learning curve on significant outcomes, such as high grade complications and positive surgical margins, has played a detrimental effect on its widespread adoption. According to this study, in tertiary referral centers, 60 procedures are sufficient to benchmark all outcomes defined in Pasadena RARC consensus.


2020 ◽  
Vol 93 (1114) ◽  
pp. 20190710
Author(s):  
Jane Rogers ◽  
Victoria Sherwood ◽  
Sarah C. Wayte ◽  
Jonathan A. Duffy ◽  
Spyros Manolopoulos

Objective: Limited visibility of post-resection muscle-invasive bladder cancer (MIBC) on CT hinders radiotherapy dose escalation of the residual tumour. Diffusion-weighted MRI (DW-MRI) visualises areas of high tumour burden and is increasingly used within diagnosis and as a biomarker for cancer. DW-MRI could, therefore, facilitate dose escalation, potentially via dose-painting and/or accommodating response. However, the distortion inherent in DW-MRI could limit geometric accuracy. Therefore, this study aims to quantify DW-MRI distortion via imaging of a bladder phantom. Methods: A phantom was designed to mimic MIBC and imaged using CT, DW-MRI and T2W-MRI. Fiducial marker locations were compared across modalities and publicly available software was assessed for correction of magnetic susceptibility-related distortion. Results: Fiducial marker locations on CT and T2W-MRI agreed within 1.2 mm at 3 T and 1.8 mm at 1.5 T. The greatest discrepancy between CT and apparent diffusion coefficient (ADC) maps was 6.3 mm at 3 T, reducing to 1.8 mm when corrected for distortion. At 1.5 T, these values were 3.9 mm and 1.7 mm, respectively. Conclusions: Geometric distortion in DW-MRI of a model bladder was initially >6 mm at 3 T and >3 mm at 1.5 T; however, established correction methods reduced this to <2 mm in both cases. Advances in knowledge: A phantom designed to mimic MIBC has been produced and used to show distortion in DW-MRI can be sufficiently mitigated for incorporation into the radiotherapy pathway. Further investigation is therefore warranted to enable individually adaptive image-guided radiotherapy of MIBC based upon DW-MRI.


2015 ◽  
Vol 4 (3) ◽  
pp. 283-290 ◽  
Author(s):  
David R. Raleigh ◽  
Albert J. Chang ◽  
Maurice Garcia ◽  
Christopher McGuinness ◽  
Dilini Pinnaduwage ◽  
...  

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