Efficacy and safety of Parecoxib for prevention of catheter-related bladder discomfort in patients undergoing transurethral resection of bladder tumor: Prospective randomised trial.

BACKGROUND AND AIMS: Catheter-related bladder discomfort (CRBD) is the urge to void or discomfort in the suprapubic region secondary to an indwelling urinary catheter. We aimed to evaluate the safety and efficacy of single-dose of intravenous parecoxib in reducing the incidence and severity of CRBD in patients undergoing transurethral resection of bladder tumor (TURBT). METHODS: Sixty-one adult patients, American Society of Anesthesiologists physical status I or II, undergoing elective TURBT under spinal anaesthesia, were randomly allocated to receive 40 mg of IV parecoxib (group P; n = 29) or an equal volume of normal saline (control group C; n = 32). CRBD was graded as none, mild, moderate, and severe. Between-group comparisons were made for the incidence and severity of CRBD, postoperative Visual analog scales (VAS), rescue analgesia equirements, and occurrence of adverse events. Statistical analysis done with the Mann-Whitney U-test and Fisher's Exact Test. A P value of ≤ 0.05 was considered statistically significant. RESULTS: Parecoxib significantly reduced the incidence and severity of CRBD at 2, 4, 6, and 12 hours postoperatively compared to placebo (P < 0.05). Median pain VAS scores were lower in the P group at all times except the first hour. Rescue analgesia was given to more patients in group C (16/32, 50%) than in group P (1/29) (P < 0.001). None of the patients who received parecoxib experienced an adverse event. CONCLUSION: A single intravenous injection of parecoxib is safe and effective in decreasing the incidence and severity of CRBD in patients undergoing TURBT. TRIAL REGISTRATION IDENTIFIER: NCT02729935(www.clinicaltrials.gov).

Comparison of Radiation Exposure during Endovascular Treatment of Peripheral Arterial Disease with Flat-Panel Detectors on Mobile C-arm versus Fixed Systems.

BACKGROUND: Flat-panel detectors on mobile C-arm (MC-arm) systems are currently challenging fixed C-arm (FC-arm) systems used in hybrid operating rooms. MC-arm systems offer an alternative to FC-arm systems in the endovascular treatment of peripheral arterial disease (PAD) but their efficiency has not been evaluated comparatively. METHODS: Two series of patients undergoing arteriography with intention to treat were included. Each series consisted of 2 nonrandomized groups: an MC-arm group and an FC-arm group. Series 1 evaluated exposure to the patient (MC-arm, n = 113; FC-arm, n = 206) while series 2 evaluated exposure to patients and also health care personnel (MC-arm, n = 24; FC-arm, n = 76). The primary end points for evaluating exposure were air kerma (AK, in mGy) for patients and effective dose for health care personnel (in µSv). RESULTS: After adjustment for the effect of body mass index (analysis of covariance test), AK was found to be lower in the MC-arm group than in the FC-arm group (124.1 ± 142 vs. 173.3 ± 248.7, P = 0.025). There was no difference between the groups with regard to effective dose recorded for senior surgeons or for operating room nurses. However, a higher effective dose was recorded by the MC-arm group external dosimeter for the trainee resident and for nurse anesthetists. CONCLUSIONS: In endovascular treatment of lower limb PAD, use of an FC-arm system is associated with more radiation exposure to the patient than an MC-arm system. However, this type of imaging system does not appear to affect exposure to health care personnel.

Revisiting the Robustness of PET-Based Textural Features in the Context of Multi-Centric Trials.

PURPOSE: This study aimed to investigate the variability of textural features (TF) as a function of acquisition and reconstruction parameters within the context of multi-centric trials. METHODS: The robustness of 15 selected TFs were studied as a function of the number of iterations, the post-filtering level, input data noise, the reconstruction algorithm and the matrix size. A combination of several reconstruction and acquisition settings was devised to mimic multi-centric conditions. We retrospectively studied data from 26 patients enrolled in a diagnostic study that aimed to evaluate the performance of PET/CT 68Ga-DOTANOC in gastro-entero-pancreatic neuroendocrine tumors. Forty-one tumors were extracted and served as the database. The coefficient of variation (COV) or the absolute deviation (for the noise study) was derived and compared statistically with SUVmax and SUVmean results. RESULTS: The majority of investigated TFs can be used in a multi-centric context when each parameter is considered individually. The impact of voxel size and noise in the input data were predominant as only 4 TFs presented a high/intermediate robustness against SUV-based metrics (Entropy, Homogeneity, RP and ZP). When combining several reconstruction settings to mimic multi-centric conditions, most of the investigated TFs were robust enough against SUVmax except Correlation, Contrast, LGRE, LGZE and LZLGE. CONCLUSION: Considering previously published results on either reproducibility or sensitivity against delineation approach and our findings, it is feasible to consider Homogeneity, Entropy, Dissimilarity, HGRE, HGZE and ZP as relevant for being used in multi-centric trials.

Quantitative Evaluation of Therapeutic Response by FDG-PET-CT in Metastatic Breast Cancer.

PURPOSE: To assess the therapeutic response for metastatic breast cancer with (18)F-FDG position emission tomography (PET), this retrospective study aims to compare the performance of six different metabolic metrics with PERCIST, PERCIST with optimal thresholds, and an image-based parametric approach. METHODS: Thirty-six metastatic breast cancer patients underwent 128 PET scans and 123 lesions were identified. In a per-lesion and per-patient analysis, the performance of six metrics: maximum standardized uptake value (SUVmax), SUVpeak, standardized added metabolic activity (SAM), SUVmean, metabolic volume (MV), total lesion glycolysis (TLG), and a parametric approach (SULTAN) were determined and compared to the gold standard (defined by clinical assessment and biological and conventional imaging according RECIST 1.1). The evaluation was performed using PERCIST thresholds (for per-patient analysis only) and optimal thresholds (determined by the Youden criterion from the receiver operating characteristic curves). RESULTS: In the per-lesion analysis, 210 pairs of lesion evolutions were studied. Using the optimal thresholds, SUVmax, SUVpeak, SUVmean, SAM, and TLG were significantly correlated with the gold standard. SUVmax, SUVpeak, and SUVmean reached the best sensitivity (91, 88, and 83%, respectively), specificity (93, 95, and 97%, respectively), and negative predictive value (NPV, 90, 88, and 83%, respectively). For the per--patient analysis, 79 pairs of PET were studied. The optimal thresholds compared to the PERCIST threshold did not improve performance for SUVmax, SUVpeak, and SUVmean. Only SUVmax, SUVpeak, SUVmean, and TLG were correlated with the gold standard. SULTAN also performed equally: 83% sensitivity, 88% specificity, and NPV 86%. CONCLUSION: This study showed that SUVmax and SUVpeak were the best parameters for PET evaluation of metastatic breast cancer lesions. Parametric imaging is helpful in evaluating serial studies.

Comparison of PET metabolic indices for the early assessment of tumour response in metastatic colorectal cancer patients treated by polychemotherapy.

PURPOSE: To compare the performance of eight metabolic indices for the early assessment of tumour response in patients with metastatic colorectal cancer (mCRC) treated with chemotherapy. METHODS: Forty patients with advanced mCRC underwent two FDG PET/CT scans, at baseline and on day 14 after chemotherapy initiation. For each lesion, eight metabolic indices were calculated: four standardized uptake values (SUV) without correction for the partial volume effect (PVE), two SUV with correction for PVE, a metabolic volume (MV) and a total lesion glycolysis (TLG). The relative change in each index between the two scans was calculated for each lesion. Lesions were also classified as responding and nonresponding lesions using the Response Evaluation Criteria In Solid Tumours (RECIST) 1.0 measured by contrast-enhanced CT at baseline and 6-8 weeks after starting therapy. Bland-Altman analyses were performed to compare the various indices. Based on the RECIST classification, ROC analyses were used to determine how accurately the indices predicted lesion response to therapy later seen with RECIST. RESULTS: RECIST showed 27 responding and 74 nonresponding lesions. Bland-Altman analyses showed that the four SUV indices uncorrected for PVE could not be used interchangeably, nor could the two SUV corrected for PVE. The areas under the ROC curves (AUC) were not significantly different between the SUV indices not corrected for PVE. The mean SUV change in a lesion better predicted lesion response without than with PVE correction. The AUC was significantly higher for SUV uncorrected for PVE than for the MV, but change in MV provided some information regarding the lesion response to therapy (AUC >0.5). CONCLUSION: In these mCRC patients, all SUV uncorrected for PVE accurately predicted the tumour response on day 14 after starting therapy as assessed 4 to 6 weeks later (i.e. 6 to 8 weeks after therapy initiation) using the RECIST criteria. Neither correcting SUV for PVE nor measuring TLG improved the assessment of tumour response compared to SUV uncorrected for PVE. The change in MV was the least accurate index for predicting tumour response.

Lesion-based detection of early chemosensitivity using serial static FDG PET/CT in metastatic colorectal cancer.

PURPOSE: Medical oncology needs early identification of patients that are not responding to systemic therapy. (18)F-Fluorodeoxyglucose (FDG) positron emission tomography (PET) performed before and early during treatment has been proposed for this purpose. However, the best way to assess the change in FDG uptake between two scans has not been identified. We studied cutoff thresholds to identify responding tumours as a function of the method used to measure tumour uptake. METHODS: The study included 28 metastatic colorectal cancer (mCRC) patients who underwent 2 FDG PET/CT scans (baseline and at day 14 of the first course of polychemotherapy). For 78 tumour lesions, 4 standardized uptake value (SUV) indices were measured: maximum SUV (SUV(max)) and mean SUV in a region obtained using an isocontour (SUV(40 %)), with each of these SUV normalized either by the patient body weight (BW) or body surface area (BSA). The per cent change and absolute change in tumour uptake between the baseline and the early PET scans were measured based on these four indices. These changes were correlated to the RECIST 1.0-based response using contrast-enhanced CT at baseline and at 6-8 weeks on treatment. RESULTS: The 78 tumours were classified as non-responding (NRL, n = 58) and responding lesions (RL, n = 20). Receiver-operating characteristic (ROC) curves characterizing the performance in NRL/RL classification using early FDG PET uptake had areas under the curve between 0.75 and 0.84, without significant difference between the indices. The cutoff threshold in FDG uptake per cent change to get a 95 % sensitivity of RL detection depended on the way uptake was measured: -14 % (specificity of 53 %) and -22 % (specificity of 64 %) for SUV(max) and SUV(40 %), respectively. Thresholds expressed as absolute SUV decrease instead of per cent change were less sensitive to the SUV definition: an SUV decline by 1.2 yielded a sensitivity of RL detection of 95 % for SUV(max) and SUV(40 %). For a given cutoff threshold, the sensitivity was the same whatever the normalization (by BSA or BW). CONCLUSION: A 14 % drop of tumour FDG SUV(max), 22 % drop of SUV(40 %) or 1.2 drop of SUV(max) or SUV(mean) after one single course of polychemotherapy predicts objective response in mCRC lesions with a high sensitivity, potentially allowing the early identification of non-responding patients.

Detection and characterization of tumor changes in 18F-FDG PET patient monitoring using parametric imaging.

UNLABELLED: In PET-based patient monitoring, metabolic tumor changes occurring between PET scans are most often assessed visually or by measuring only a few parameters (tumor volume or uptake), neglecting most of the image content. We propose and evaluate a parametric imaging (PI) method to assess tumor changes at the voxel level. METHODS: Seventy-eight pairs of tumor images obtained from baseline and follow-up (18)F-FDG PET/CT for 28 patients with metastatic colorectal cancer were considered. For each pair, after CT-based registration of the PET volumes, the 2 PET datasets were subtracted. A biparametric graph of subtracted voxel values versus voxel values in the first PET scan was obtained. A model-based analysis of this graph was used to identify the tumor voxels in which significant changes occurred between the 2 scans and yielded indices characterizing these changes. The Response Evaluation Criteria in Solid Tumors (RECIST) based on the CT images obtained 5-8 wk after the second PET/CT scan were used to classify tumor masses as responding or progressive. On the basis of this classification, we compared the sensitivity and specificity of PI and an approach based on recommendations from the European Organization for Research and Treatment of Cancer (EORTC). RESULTS: For tumor-based classification, the EORTC-based approach had a sensitivity and specificity of 85% and 52%, respectively, for detecting responding lesions, whereas PI had a sensitivity and specificity of 100% and 53%, respectively. None of responding tumors using RECIST was classified as progressive with the PI or EORTC-based criteria. Among the 14 progressive lesions according to RECIST, 12 were identified as progressive with PI whereas EORTC-based criteria classified only 1 as progressive and 13 as stable tumors. Considering the patient-based classification, none of the responders according to RECIST was classified as having progressive disease with the PI and EORTC-based criteria. PI has the advantage of showing a parametric image of the patient response to therapy, indicating potential heterogeneity in tumor response. CONCLUSION: The PI method has been successfully applied to characterize early metabolic tumor changes in 78 lesions from (18)F-FDG PET/CT scans of patients with metastatic colorectal cancer during chemotherapy. The PI findings correlated well with the standard RECIST-based response assessment.