Three-dimensional ERUS is easy to carry out using this new software program. There is no need for an external sensor mounted at the tip of the probe, and manipulation of the rectal probe is facilitated. Three-dimensional ERUS can be carried out using linear and radial electronic probes with the same ultrasound equipment. Three-dimensional ERUS allows more precise staging of lesions and better definition of the mesorectal margins, and this has a direct impact on therapeutic decision-making in patients with rectal cancer.
Purpose
This prospective monocentric phase II study (FIDUCOR-study) aimed at the assessment of the impact of fiducial markers (FMs) implantation on conformal chemo-radiation therapy (CRT) planning in esophageal carcinoma (EC) patients.
Methods/materials
Fifteen EC patients were enrolled in the study. Each patient underwent two simulation CT-scans before (CT1) and after (CT2) FMs implantation, in the same position. FMs (3 mm length gold markers, preloaded in a 22G needle) were implanted after sedation, under EUS and X-Ray guidance, and were placed at the tumor’s extremities, and in the visible lymph nodes. Target delineation and treatment plan were both performed first on CT1 with the assistance of, diagnosis-CT, gastroscopy- and EUS-details, and second on CT2 using FMs and CT-data. The value of FMs implantation was assessed by the difference of growth-tumor-volume (GTV) and clinical-target-volume (CTV) between CT1-based and CT2-based delineation. A significant difference was defined as a ≥5 mm-difference on axial(x) or coronal(y) slices, a ≥10mm-difference on sagittal slices, or a ≥20%-difference in GTV. The impact on dose distribution in organs at risk (OAR) (lung, heart, liver) was also studied.
Results
Between 09/2014 and 12/2015, 15 patients could achieve fiducial procedures, without any complication. One FM migration occurred. We observed a significant modification of the GTV-dimension in 100% of the cases (15/15, 95%CI: [78.2;100.0]), mainly due to a difference in sagittal dimension with a mean variation of 11.2 mm and a difference> 10 mm for 8/15 patients (53.3%). One patient had a significant isocenter displacement as high as 20 mm. The esophagus tumor was not seen on the CT-scan in one patient due to its small size. One patient had a distant lymph node metastasis not visible on CT-scan. We observed no significant impact on OAR distribution.
Conclusion
In our study, FMs-implantation appeared to have positive impact on accurate volume definition in EC-patients.
Registration trial number
NCT02526134 since the 06-18-2013 ; URL https://clinicaltrials.gov/ct2/show/NCT02526134
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