Clinical effectiveness of combined whole body hyperthermia and external beam radiation therapy (EBRT) versus EBRT alone in patients with painful bony metastases: A phase III clinical trial study.

PURPOSE: To evaluate the response rate, pain relief duration, and time it took for pain to decline or resolve after radiation therapy (RT) with or without fever-range Whole Body Hyperthermia (WBH) in bony metastatic patients with mainly primary tumor of prostate and breast cancer leading to bone pain. MATERIALS & METHODS: Bony metastatic patients with pain score ≥4 on the Brief Pain Inventory (BPI) underwent RT of 30 Gy in 10 fractions in combination with WBH with nursing care under medical supervision versus RT-alone. WBH application time was 3-4 h in three fractions with at least 48-h intervals. All patients were stratified primary site, breast or prostate cancer vs others, BPI score, and exclusion criteria. The primary endpoint was complete response (CR) (BPI equal to zero with no increase of analgesics) within two months of follow-up. RESULTS: Based on this study, the RT-alone group showed the worst pain. The study was terminated after the enrollment of a total of 61 patients, 5 years after the first enrollment (April 2016 to February 2021). Finally, the CR rate in RT + WBH revealed the most significant difference with RT-alone, 47.4% versus 5.3% respectively within 2 months post-treatment (P-value <0.05). The time of complete pain relief was 10 days for RT + WBH, while the endpoint was not reached during the RT-alone arm. Pain progression or stable disease was observed in half of the patients in RT-alone group within 4 weeks after treatment. However, this score was near zero in RT + WBHT patients in two months post-treatment. CONCLUSIONS: WBH plus RT showed significant increases in pain relief and shorter response time in comparison with RT-alone for patients with bone metastatic lesions.

Coronary artery calcification: Effects on severity and survival in patients with COVID-19.

Background: The aim of this study was to evaluate the effect of coronary artery calcification on disease severity and prognosis in patients with coronavirus disease-2019 (COVID-19). Materials and Methods: One hundred and forty-one patients with COVID-19 were included in this study. The severity of pulmonary involvement and calcification of coronary arteries were assessed by computed tomography scan and calcification was classified by two methods: Weston and segmental. In both the methods, patients were divided into three groups with scores of 0, 1-6, and 7-12, which are called groups 1, 2, and 3, respectively. Results: The mean age of patients was 54.26 ± 14.55. Difference in score of pulmonary involvement was reported to be significant between deceased and discharged patients (11.73 ± 5.26 and 7.28 ± 4.47, P = 0.002, respectively). In Weston score system, the chance of recovery of Group 1 patients was significantly higher than Group 3 (odds ratio [OR] =6.72, P = 0.05, 95% confidence interval [CI] =1.901-50.257). Similar results were observed in the segmental scoring system (OR =6.34, P = 0.049, 95% CI =1.814-49.416). Despite the higher chance of severe disease in patients with coronary artery calcification, this increase was not statistically significant in either Weston or segmental methods (OR =0.47, P = 0.23 and OR =0.85, P = 0.79, respectively). Conclusion: Coronary artery calcification in patients with COVID-19 has a significant association with poor prognosis. However, no significant relationship was observed between this issue and the severity.

Anatomical Findings of Renal and Urological Abnormalities in Cardiac Catheterization of Children with congenital heart diseases - A Single Center Experience.

ackground and aims: Congenital heart disease (CHD) is described as an abnormality in the heart structure or intra-thoracic great vessels that leads to functional problems. Since most of these disorders require medical and surgical interventions identifying concomitant disorders such as renal and urinary tract abnormalities is of great importance in the management of these patients. The present study aimed to investigate the relative frequency of abnormal kidney and urinary tract findings in abdominal cineangiography during cardiac catheterization of patients with CHD in Shahid Modarres Cardiovascular Medical and Research Center. METHODS: The present study was performed prospectively on 545 patients aged < 18 years with CHD who underwent cardiac catheterization and concurrent abdominal cineangiography in Shahid Modarres Cardiovascular, Medical and Research Center, Tehran, Iran during a three-year period. The required data were extracted using a researcher-made questionnaire from patients' electronic medical files. RESULTS: Of a total of 545 patients in this study, 26 had both CHD and renal or urinary tract malformation. Patent ductus arteriosus was the most common CHD in patients with renal or urinary tract malformations (odds ratio: 1.2, 95%, CI: 2.25-11.63). In this study, the most common renal and urinary malformations among CHD patients was partial duplication of the kidney followed by Ureteropelvic Junction Obstruction. CONCLUSION: Since the prevalence of renal and urinary tract malformations is higher in CHD patients, performance of concurrent abdominal cineangiography during cardiac catheterization may lead to early diagnosis and treatment as well as better pre- and post-operative management of patients.

Randomized, double-blind, placebo-controlled phase II trial of nanocurcumin in prostate cancer patients undergoing radiotherapy.

Clinical potential of curcumin in radiotherapy (RT) setting is outstanding and of high interest. The main purpose of this randomized controlled trial (RCT) was to assess the beneficial role of nanocurcumin to prevent and/or mitigate radiation-induced proctitis in prostate cancer patients undergoing RT. In this parallel-group study, 64 eligible patients with prostate cancer were randomized to receive either oral nanocurcumin (120 mg/day) or placebo 3 days before and during the RT course. Acute toxicities including proctitis and cystitis were assessed weekly during the treatment and once thereafter using CTCAE v.4.03 grading criteria. Baseline-adjusted hematologic nadirs were also analyzed and compared between the two groups. The patients undergoing definitive RT were followed to evaluate the tumor response. Nanocurcumin was well tolerated. Radiation-induced proctitis was noted in 18/31 (58.1%) of the placebo-treated patients versus 15/33 (45.5%) of nanocurcumin-treated patients (p = 0.313). No significant difference was also found between the two groups with regard to radiation-induced cystitis, duration of radiation toxicities, hematologic nadirs, and tumor response. In conclusion, this RCT was underpowered to indicate the efficacy of nanocurcumin in this clinical setting but could provide a considerable new translational insight to bridge the gap between the laboratory and clinical practice.

Machine learning-based radiomic models to predict intensity-modulated radiation therapy response, Gleason score and stage in prostate cancer.

OBJECTIVE: To develop different radiomic models based on the magnetic resonance imaging (MRI) radiomic features and machine learning methods to predict early intensity-modulated radiation therapy (IMRT) response, Gleason scores (GS) and prostate cancer (Pca) stages. METHODS: Thirty-three Pca patients were included. All patients underwent pre- and post-IMRT T2-weighted (T2 W) and apparent diffusing coefficient (ADC) MRI. IMRT response was calculated in terms of changes in the ADC value, and patients were divided as responders and non-responders. A wide range of radiomic features from different feature sets were extracted from all T2 W and ADC images. Univariate radiomic analysis was performed to find highly correlated radiomic features with IMRT response, and a paired t test was used to find significant features between responders and non-responders. To find high predictive radiomic models, tenfold cross-validation as the criterion for feature selection and classification was applied on the pre-, post- and delta IMRT radiomic features, and area under the curve (AUC) of receiver operating characteristics was calculated as model performance value. RESULTS: Of 33 patients, 15 patients (45%) were found as responders. Univariate analysis showed 20 highly correlated radiomic features with IMRT response (20 ADC and 20 T2). Two and fifteen T2 and ADC radiomic features were found as significant (P-value ≤ 0.05) features between responders and non-responders, respectively. Several cross-combined predictive radiomic models were obtained, and post-T2 radiomic models were found as high predictive models (AUC 0.632) followed by pre-ADC (AUC 0.626) and pre-T2 (AUC 0.61). For GS prediction, T2 W radiomic models were found as more predictive (mean AUC 0.739) rather than ADC models (mean AUC 0.70), while for stage prediction, ADC models had higher prediction performance (mean AUC 0.675). CONCLUSIONS: Radiomic models developed by MR image features and machine learning approaches are noninvasive and easy methods for personalized prostate cancer diagnosis and therapy.

A cost-free approach to evaluating vertebral body bone density and height loss in lung transplant recipients using routine chest CT.

BACKGROUND: To assess changes in bone density and vertebral body height of patients undergoing lung transplant surgery using computed tomography (CT). METHODS: This institutional review board (IRB) approved retrospective observational study enrolled patients with a history of lung transplant who had at least two chest CT scans. Vertebral body bone density (superior, middle, and inferior sections) and height (anterior, middle, and posterior sections) were measured at T1-T12 at baseline and follow up CT scans. Changes in the mean bone density, mean vertebral height, vertebral compression ratio (VBCR), percentage of anterior height compression (PAHC), and percentage of middle height compression (PMHC) were calculated and analyzed. RESULTS: A total of 93 participants with mean age of 58 ± 12.3 years were enrolled. The most common underlying disease that led to lung transplants was interstitial lung diseases (57 %). The inter-scan interval was 34.06 ± 24.8 months. There were significant changes (p-value < 0.05) in bone density at all levels from T3 to T12, with the greatest decline at the T10 level from 163.06 HU to 141.84 HU (p-value < 0.05). The average VBCR decreased from 96.91 to 96.15 (p-value < 0.05). CONCLUSION: Routine chest CT scans demonstrate a gradual decrease in vertebral body bone density over time in lung transplant recipients, along with evident anatomic changes such as vertebral body bone compression. This study shows that utilizing routine chest CT for lung transplant recipients can be regarded as a cost-free tool for assessing the vertebral body bone changes in these patients and potentially aiding in the prevention of complications related to osteoporosis.

Studying the effect of donor kidney volume ratios to recipients' body surface area, body mass index, and total body weight on post-transplant graft function.

OBJECTIVES: The goal of this study was to retrospectively investigate the relationship between renal transplanted volume indexes (Total kidney volume (TKV)/Body surface area (BSA), Renal parenchymal volume (RPV)/BSA, Renal cortical volume (RCV)/BSA, RPV/Body mass index (BMI), RCV/BMI, RPV/Weight, RCV/Weight), and short- and long-term function of the graft. METHODS: One-hundred and twelve live donor-recipient pairs from 2017 to 2018, whose donors underwent preoperative renal computed tomography angiography and recipients survived during 12 months of follow-up, were included in this study. RESULTS: The crude and adjusted linear regressions for the effect of volume measurements by voxel and ellipsoid methods on the estimated glomerular filtration rate (eGFR) at different post-transplantation times demonstrated that the RPV/weight ratio had the most substantial crude effect on the eGFR 12 months and 4 years after renal transplant. Receiver operating characteristic (ROC) curves for six different renal volume ratios demonstrated no significant difference between these ratios in terms of discriminative ability (p value < 0.05). A strong direct correlation between TKV calculated by the ellipsoid formula with RPV and RCV measured using OsiriX software was noted. Analysis of ROC curves for renal volume indices has demonstrated fair to good discriminative ability of our cut-off points to estimate 4-year post-transplantation eGFR > 60 mL/min. CONCLUSION: Renal transplant recipients' volume indices, such as RPV/weight, had strong correlations with eGFR at different points in time, and renal transplant recipients with the volume ratios higher than our cut-off points had a good chance of having a 4-year post-transplantation eGFR higher than 60 mL/min.

Developing optimized fMRI protocol for clinical use: comparison of different language paradigms.

PURPOSE: To compare the potential of five functional magnetic resonance imaging (fMRI) language paradigms in activating language areas in Persian-speaking volunteers in order to optimize these tasks for clinically useful protocol. MATERIALS AND METHODS: 16 healthy right-handed Persian-speaking volunteers were studied. Each individual performed five tasks during the fMRI scan: word generation (WG), object naming (ON), word reading (WR), word production (WP), and reverse word reading (RWR). The ability of each task to activate classical language areas was assessed using group analysis. In addition, the lateralization index (LI) for each subject-task was calculated and compared. RESULTS: We found that WP, RWR, and WG robustly activated language-related areas in the dominant hemisphere. ON and WR failed to sufficiently delineate these activation areas. Highest activation intensities in the frontal lobe (including Broca's area) were seen with WP, whereas RWR showed the highest LI among all examined tasks. CONCLUSION: Our results demonstrated that the Persian version of WG and newly presented WP and RWR tasks can be reliably used for localization of language-related areas in Persian speakers. This type of language evaluation may be used in presurgical planning of neurosurgical procedures in the Persian population. We recommend application of WP and RWR in future researches establishing the optimized protocol for other language speakers.

The feasibility of a dose painting procedure to treat prostate cancer based on mpMR images and hierarchical clustering.

BACKGROUND: We aimed to assess the feasibility of a dose painting (DP) procedure, known as simultaneous integrated boost intensity modulated radiation Therapy (SIB-IMRT), for treating prostate cancer with dominant intraprostatic lesions (DILs) based on multi-parametric magnetic resonance (mpMR) images and hierarchical clustering with a machine learning technique. METHODS: The mpMR images of 120 patients were used to create hierarchical clustering and draw a dendrogram. Three clusters were selected for performing agglomerative clustering. Then, the DIL acquired from the mpMR images of 20 patients were categorized into three groups to have them treated with a DP procedure being composed of three planning target volumes (PTVs) determined as PTV1, PTV2, and PTV3 in treatment plans. The DP procedure was carried out on the patients wherein a total dose of 80, 85 and 91 Gy were delivered to the PTV1, PTV2, and PTV3, respectively. Dosimetric and radiobiologic parameters [Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP)] of the DP procedure were compared with those of the conventional IMRT and Three-Dimensional Conformal Radiation Therapy (3DCRT) procedures carried out on another group of 20 patients. A post-treatment follow-up was also made four months after the radiotherapy procedures. RESULTS: All the dosimetric variables and the NTCPs of the organs at risks (OARs) revealed no significant difference between the DP and IMRT procedures. Regarding the TCP of three investigated PTVs, significant differences were observed between the DP versus IMRT and also DP versus 3DCRT procedures. At post-treatment follow-up, the DIL volumes and apparent diffusion coefficient (ADC) values in the DP group differed significantly (p-value < 0.001) from those of the IMRT. However, the whole prostate ADC and prostate-specific antigen (PSA) indicated no significant difference (p-value > 0.05) between the DP versus IMRT. CONCLUSIONS: The results of this comprehensive clinical trial illustrated the feasibility of our DP procedure for treating prostate cancer based on mpMR images validated with acquired patients' dosimetric and radiobiologic assessment and their follow-ups. This study confirms significant potential of the proposed DP procedure as a promising treatment planning to achieve effective dose escalation and treatment for prostate cancer. TRIAL REGISTRATION: IRCT20181006041257N1; Iranian Registry of Clinical Trials, Registered: 23 October 2019, https://en.irct.ir/trial/34305 .

Risk Factors for Poor Outcome in Patients with Severe Viral Pneumonia on Chest CT during the COVID-19 Outbreak: a Perspective from Iran.

We investigated significant predictors of poor in-hospital outcomes for patients admitted with viral pneumonia during the COVID-19 outbreak in Tehran, Iran. Between February 22 and March 22, 2020, patients who were admitted to three university hospitals during the COVID-19 outbreak in Tehran, Iran were included. Demographic, clinical, laboratory, and chest CT scan findings were gathered. Two radiologists evaluated the distribution and CT features of the lesions and also scored the extent of lung involvement as the sum of three zones in each lung. Of 228 included patients, 45 patients (19.7%) required ICU admission and 34 patients (14.9%) died. According to regression analysis, older age (OR = 1.06; P < 0.001), blood oxygen saturation (SpO2) < 88% (OR = 2.88; P = 0.03), and higher chest CT total score (OR = 1.10; P = 0.03) were significant predictors for in-hospital death. The same three variables were also recognized as significant predictors for invasive respiratory support: SpO2 < 88% (OR = 3.97, P = 0.002), older age (OR = 1.05, P < 0.001), and higher CT total score (OR = 1.13, P = 0.008). Potential predictors of invasive respiratory support and in-hospital death in patients with viral pneumonia were older age, SpO2 < 88%, and higher chest CT score.

Novel coronavirus disease 2019: predicting prognosis with a computed tomography-based disease severity score and clinical laboratory data.

INTRODUCTION: Currently, there are known contributing factors but no comprehensive methods for predicting the mortality risk or intensive care unit (ICU) admission in patients with novel coronavirus disease 2019 (COVID­19). OBJECTIVES: The aim of this study was to explore risk factors for mortality and ICU admission in patients with COVID­19, using computed tomography (CT) combined with clinical laboratory data. PATIENTS AND METHODS: Patients with polymerase chain reaction-confirmed COVID­19 (n = 63) from university hospitals in Tehran, Iran, were included. All patients underwent CT examination. Subsequently, a total CT score and the number of involved lung lobes were calculated and compared against collected laboratory and clinical characteristics. Univariable and multivariable proportional hazard analyses were used to determine the association among CT, laboratory and clinical data, ICU admission, and in­hospital death. RESULTS: By univariable analysis, in­hospital mortality was higher in patients with lower oxygen saturation on admission (below 88%), higher CT scores, and a higher number of lung lobes (more than 4) involved with a diffuse parenchymal pattern. By multivariable analysis, in­hospital mortality was higher in those with oxygen saturation below 88% on admission and a higher number of lung lobes involved with a diffuse parenchymal pattern. The risk of ICU admission was higher in patients with comorbidities (hypertension and ischemic heart disease), arterial oxygen saturation below 88%, and pericardial effusion. CONCLUSIONS: We can identify factors affecting in­hospital death and ICU admission in COVID-19. This can help clinicians to determine which patients are likely to require ICU admission and to inform strategic healthcare planning in critical conditions such as the COVID­19 pandemic.

Diagnostic Accuracy of Dual-Source Computerized Tomography Coronary Angiography in Symptomatic Patients Presenting to a Referral Cardiovascular Center During Daily Clinical Practice.

BACKGROUND: There are numerous studies that address the diagnostic value of dual-source computed tomography (DSCT) as an alternative to conventional coronary angiography (CCA). However, the benefit of application of DSCT in a real world clinical setting should be evaluated. OBJECTIVES: To determine the diagnostic accuracy of DSCT technique compared with CCA as the gold standard method in detection of coronary artery stenosis among symptomatic patients who are presented to a referral cardiovascular center during daily clinical practice. PATIENTS AND METHODS: Evaluating the medical records of a tertiary care referral cardiovascular center, 47 patients who had undergone DSCT and CCA, and also met the inclusion and exclusion criteria of the study were selected. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and likelihood ratios (LRs) of the DSCT imaging technique were calculated. RESULTS: In total, 97.8% of the segments (628/642) could be visualized with diagnostic image quality via DSCT coronary angiography. The mean heart rate during DSCT was 69.2 ± 12.2 bpm (range: 39 - 83 bpm), and the mean Agatston score was 507.7 ± 590.5 (range: 0 - 2328). Per segment analysis of the findings revealed that the sensitivity, specificity, PPV, NPV, positive LR (PLR) and negative LR (NLR) of DSCT technique for evaluation of patients with coronary artery disease were 93.7%, 96.8%, 92.7%, 97.2%, 29.4, and 0.066, respectively. Also per vessel, analysis of the findings showed a sensitivity of 97.1%, a specificity of 94.0%, PPV of 95.3%, NPV of 96.3%, PLR of 16.1, and NLR of 0.030. CONCLUSION: Our results indicate that DSCT coronary angiography provides high diagnostic accuracy for the evaluation of CAD patients during daily routine practice of a referral cardiovascular setting.

Functional MRI in clinical practice: Assessment of language and motor for pre-surgical planning.

Functional magnetic resonance imaging (fMRI) has been widely used for pre-neurosurgical planning and may eventually become a routine pre-surgical imaging modality. The validity of fMRI for clinical application depends on various factors such as proper task selection, correct statistical analysis and threshold setting with appropriate patient cooperation. This study was performed on 40 patients with different types of brain mass lesions or hippocampal sclerosis to assess the role of appropriate patient selection for achieving a reliable fMRI result. Accurate and reproducible fMRI strongly depends on the patient's cooperation. In this study we observed that a pre-test mock fMRI session held by a radiologist may help to predict which patients are more or less suitable candidates for fMRI.

The Effect of Preoperative Weight Loss before Gastric Bypass: A Systematic Review.

Background. Many insurance companies require obese patients to lose weight prior to gastric bypass. From a previous study by the same authors, preoperative weight at surgery is strongly predictive of weight loss up to one year after surgery. This review aims to determine whether preoperative weight loss is also correlated with weight loss up to one year after surgery. Methods. Of the 186 results screened using PubMed, 12 studies were identified. A meta-analysis was performed to further classify studies (A class, B class, regression, and rejected). Results. Of all 12 studies, one met the criteria for A class, six were B class, four were regression, and one was rejected. Six studies supported our hypothesis, five were inconclusive, and no study refuted. Conclusions. Preoperative weight loss is additive to postsurgery weight loss as predicted from the weight at the time of surgery.