Trabecular Bone Score Change Is Not Predicted by Bone Turnover: Short-term Sequential Follow-up.

BACKGROUND: Trabecular bone score (TBS) reflects vertebrae microarchitecture and assists in fracture risk assessment. The International Society of Clinical Densitometry postulates that the role of TBS in monitoring antiresorptive therapy is unclear. Whether changes in TBS correlate with bone resorption measured by bone turnover markers is not known. OBJECTIVES: To determine whether longitudinal changes in TBS correlate with C-terminal telopeptide (CTX) of type I collagen. METHODS: Examinees with two bone mineral density (BMD) measurements were detected via the institutional database. Over 5.8% change in TBS was considered least significant and patients were grouped accordingly (increment, decrement, or unchanged). CTX, BMD, co-morbidities, incident fractures, and medication exposure were compared between the groups by Kruskal-Wallis. The correlation between TBS and BMD change and CTX in a continuous model was analyzed by Pearson's correlation coefficient. RESULTS: In total, 110 patients had detailed medical records. In 74.5%, TBS change was below least significant change. Two other TBS categories, fracture incidence or medication exposure, did not differ by CTX. In the continuous model, BMD and TBS change was positively correlated (r = 0.225, P = 0.018). A negative correlation was observed between BMD change and CTX. The decrease in BMD level was associated with higher CTX (r = -0.335, P = 0.004). No correlation was observed between CTX and TBS. CONCLUSIONS: No correlation between TBS dynamics and bone resorption marker was found. Clinical interpretation and implication of longitudinal TBS changes should be further explored.

FDG PET/CT radiomics as a tool to differentiate between reactive axillary lymphadenopathy following COVID-19 vaccination and metastatic breast cancer axillary lymphadenopathy: a pilot study.

OBJECTIVES: To evaluate if radiomics with machine learning can differentiate between F-18-fluorodeoxyglucose (FDG)-avid breast cancer metastatic lymphadenopathy and FDG-avid COVID-19 mRNA vaccine-related axillary lymphadenopathy. MATERIALS AND METHODS: We retrospectively analyzed FDG-positive, pathology-proven, metastatic axillary lymph nodes in 53 breast cancer patients who had PET/CT for follow-up or staging, and FDG-positive axillary lymph nodes in 46 patients who were vaccinated with the COVID-19 mRNA vaccine. Radiomics features (110 features classified into 7 groups) were extracted from all segmented lymph nodes. Analysis was performed on PET, CT, and combined PET/CT inputs. Lymph nodes were randomly assigned to a training (n = 132) and validation cohort (n = 33) by 5-fold cross-validation. K-nearest neighbors (KNN) and random forest (RF) machine learning models were used. Performance was evaluated using an area under the receiver-operator characteristic curve (AUC-ROC) score. RESULTS: Axillary lymph nodes from breast cancer patients (n = 85) and COVID-19-vaccinated individuals (n = 80) were analyzed. Analysis of first-order features showed statistically significant differences (p < 0.05) in all combined PET/CT features, most PET features, and half of the CT features. The KNN model showed the best performance score for combined PET/CT and PET input with 0.98 (± 0.03) and 0.88 (± 0.07) validation AUC, and 96% (± 4%) and 85% (± 9%) validation accuracy, respectively. The RF model showed the best result for CT input with 0.96 (± 0.04) validation AUC and 90% (± 6%) validation accuracy. CONCLUSION: Radiomics features can differentiate between FDG-avid breast cancer metastatic and FDG-avid COVID-19 vaccine-related axillary lymphadenopathy. Such a model may have a role in differentiating benign nodes from malignant ones. KEY POINTS: • Patients who were vaccinated with the COVID-19 mRNA vaccine have shown FDG-avid reactive axillary lymph nodes in PET-CT scans. • We evaluated if radiomics and machine learning can distinguish between FDG-avid metastatic axillary lymphadenopathy in breast cancer patients and FDG-avid reactive axillary lymph nodes. • Combined PET and CT radiomics data showed good test AUC (0.98) for distinguishing between metastatic axillary lymphadenopathy and post-COVID-19 vaccine-associated axillary lymphadenopathy. Therefore, the use of radiomics may have a role in differentiating between benign from malignant FDG-avid nodes.

Imaging of Hematological Patients in the Era of COVID-19.

The COVID-19 pandemic, caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), resulted in changes in management and imaging routines for patients with hematological malignancies. Treating physicians had to familiarize themselves with a new disease, with distinct imaging manifestations, sometimes overlapping with other infections prevalent in this patient population. In some aspects, infected hematological patients might exhibit a different disease course, and routine imaging in asymptomatic hematological patients may result in unexpected COVID-19 findings, implying covert infection, that should be further explored. Furthermore, some complications of hematological diseases and treatments may present with findings similar to COVID-19 manifestations, and treating physicians must consider both possibilities in the differential diagnosis. In this review, we aimed to present the influence the COVID-19 pandemic had on hematological malignancy imaging.

Liver Attenuation Assessment in Reduced Radiation Chest Computed Tomography.

OBJECTIVE: This study aimed to evaluate the reliability of liver and spleen Hounsfield units (HU) measurements in reduced radiation computed tomography (RRCT) of the chest within the sub-millisievert range. METHODS: We performed a prospective, institutional review board-approved study of accrued patients who underwent unenhanced normal-dose chest CT (NDCT) and with an average radiation dose of less than 5% of NDCT. In-house artificial intelligence-based denoising methods produced 2 denoised RRCT (dRRCT) series. Hepatic and splenic attenuations were measured on all 4 series: NDCT, RRCT, dRRCT1, and dRRCT2. Statistical analyses assessed the differences between the HU measurements of the liver and spleen in RRCTs and NDCT. As a test case, we assessed the performance of RRCTs for fatty liver detection, considering NDCT to be the reference standard. RESULTS: Wilcoxon test compared liver and spleen attenuation in the 72 patients included in our cohort. The liver attenuation in NDCT (median, 59.38 HU; interquartile range, 55.00-66.06 HU) was significantly different from the attenuation in RRCT, dRRCT1, and dRRCT2 (median, 63.63, 42.00, and 33.67 HU; interquartile range, 56.19-67.19, 37.33-45.83, and 30.33-38.50 HU, respectively), all with a P value <0.01. Six patients (8.3%) were considered to have fatty liver on NDCT. The specificity, sensitivity, and accuracy of fatty liver detection by RRCT were greater than 98.5%, 50%, and 94.3%, respectively. CONCLUSIONS: Attenuation measurements were significantly different between NDCT and RRCTs, but may still have diagnostic value in appreciating hepatosteastosis. Abdominal organ attenuation on RRCT protocols may differ from attenuation on NDCT and should be validated when new low-dose protocols are used.

Alerting on mortality among patients discharged from the emergency department: a machine learning model.

OBJECTIVES: Physicians continuously make tough decisions when discharging patients. Alerting on poor outcomes may help in this decision. This study evaluates a machine learning model for predicting 30-day mortality in emergency department (ED) discharged patients. METHODS: We retrospectively analysed visits of adult patients discharged from a single ED (1/2014-12/2018). Data included demographics, evaluation and treatment in the ED, and discharge diagnosis. The data comprised of both structured and free-text fields. A gradient boosting model was trained to predict mortality within 30 days of release from the ED. The model was trained on data from the years 2014-2017 and validated on data from the year 2018. In order to reduce potential end-of-life bias, a subgroup analysis was performed for non-oncological patients. RESULTS: Overall, 363 635 ED visits of discharged patients were analysed. The 30-day mortality rate was 0.8%. A majority of the mortality cases (65.3%) had a known oncological disease. The model yielded an area under the curve (AUC) of 0.97 (95% CI 0.96 to 0.97) for predicting 30-day mortality. For a sensitivity of 84% (95% CI 0.81 to 0.86), this model had a false positive rate of 1:20. For patients without a known malignancy, the model yielded an AUC of 0.94 (95% CI 0.92 to 0.95). CONCLUSIONS: Although not frequent, patients may die following ED discharge. Machine learning-based tools may help ED physicians identify patients at risk. An optimised decision for hospitalisation or palliative management may improve patient care and system resource allocation.

Assessment of Data Supporting the Efficacy of New Antibiotics for Treating Infections Caused by Multidrug-resistant Bacteria.

BACKGROUND: Infections caused by multidrug-resistant (MDR) bacteria are a major public health threat. We aimed to assess the data supporting US Food and Drug Administration (FDA) approval of new agents aimed to treat MDR bacterial infections and the data provided by postmarketing studies. METHODS: We identified all drugs with in vitro activity against MDR bacteria initially approved by the FDA between January 2010 and December 2018. Characteristics of trials supporting approval and regulatory pathways were collected from Drugs@FDA. Characteristics of postmarketing studies were extracted from drug labels and ClinicalTrials.gov entries effective 1 June 2019. RESULTS: Initial approval of 11 newly approved antibiotics with anti-MDR activity was supported by 20 trials, all with noninferiority design. All initially approved indications were for common infections, mostly acute bacterial skin and skin-structure infections, regardless of causative microorganism. The proportion of MDR bacteria in most trials was low (<10% for gram-negative infections, <1% for gram-positive pneumonia). Most trials (90%) excluded immunocompromised and critically ill patients. Of 16 additional postmarketing randomized controlled trials identified through ClinicalTrials.gov, only 2 exclusively included infections caused by MDR bacteria, comprising 116 patients. No drug was granted accelerated approval, which would mandate postmarketing efficacy studies. CONCLUSIONS: The approval of new drugs with potential clinical activity against MDR bacteria is supported by trials evaluating infections caused by non-MDR organisms, using noninferiority design and excluding the patients most likely to require these agents. Subsequent postmarketing efficacy data against these organisms are scarce. Healthcare professionals and regulators should demand more robust data to support clinical decision making.

Concordance between the results of randomized and non-randomized interventional clinical trials assessing the efficacy of drugs for COVID-19: a cross-sectional study.

OBJECTIVES: To assess whether results of observational studies of potential anti-COVID-19 drugs were reproduced in subsequent randomized controlled trials (RCTs). METHODS: This was a retrospective cross-sectional study, including studies published online between 1 January and 27 October 2020 that evaluated potential COVID-19 treatments and reported all-cause mortality. RESULTS: Of 133 comparisons included in 117 studies, most were non-randomized (104/133, 78%). Hydroxychloroquine was the most common drug type, combined with azithromycin (n = 27, 20%) or alone (n = 22, 16%), followed by IL-6 inhibitors (n = 36, 27%) and corticosteroids (n = 26, 20%). Seventy-one percent (74/104) of non-randomized studies reported adjusted survival results and only 8% (8/104) adjusted for immortal time bias. Only two RCTs (2/29, 7%) reported significant survival benefit, both reporting treatment with corticosteroids, while 32/104 (31%) non-randomized studies showed statistically significant survival benefit associated with the intervention arm. The results of the majority (28/32, 88%) of non-randomized studies reporting survival benefit were not replicated by large-scale RCTs. CONCLUSIONS: The results of most non-randomized studies reporting survival benefit of potential anti-COVID-19 drugs were not replicated by large RCTs. Regulators and healthcare professionals should exercise caution and resist the pressure to approve and prescribe drugs of unproven efficacy and potential toxicity to optimize patient care and maintain public trust in medical science.

Bloodstream infections in the elderly: what is the real goal?

Bloodstream infections (BSI) represent a serious bacterial infection with substantial morbidity and mortality. Population-based studies demonstrate an increased incidence, especially among elderly patients. Controversy exists regarding whether presentation of BSI are different in older patients compared to younger patients; our narrative review of the literature suggests that BSI in elderly patients would probably include one or more of the traditional symptoms/signs of fever, severe sepsis or septic shock, acute kidney injury, and/or leukocytosis. Sources of BSI in older adults are most commonly the urinary tract (more so than in younger adults) and the respiratory tract. Gram-negative bacteria are the most common isolates in the old (~ 40-60% of BSI); isolates from the elderly patient population show higher antibiotic resistance rates, with long-term care facilities serving as reservoirs for multidrug-resistant bacteria. BSI entail significantly higher rates of mortality in older age, both short and long term. Some of the risk factors for mortality are modifiable, such as the appropriateness of empirical antibiotic therapy and nosocomial acquisition of infection. Health-related quality of life issues regarding the elderly patient with BSI are not well addressed in the literature. Utilization of comprehensive geriatric assessment and comprehensive geriatric discharge planning need to be investigated further in this setting and might serve as key for improved results in this population. In this review, we address all these aspects of BSI in old patients with emphasis on future goals for management and research.

Postmarketing Safety of Vaccines Approved by the U.S. Food and Drug Administration : A Cohort Study.

BACKGROUND: Vaccines are one of the greatest achievements in public health. Prevalence and clinical significance of emerging postapproval, vaccine-related safety issues have not been systematically studied. OBJECTIVE: To explore postmarketing safety modifications in U.S. Food and Drug Administration (FDA)-approved vaccine labels. DESIGN: Retrospective cohort study. SETTING: United States. PARTICIPANTS: Initial and subsequent labels of all vaccines that were FDA-approved between 1 January 1996 and 31 December 2015. MEASUREMENTS: The primary aim was a descriptive analysis of the prevalence and characteristics of postapproval, safety-related label changes. The secondary aim was to describe the distribution of data sources triggering these modifications. RESULTS: The study cohort comprised 57 FDA-approved vaccines. Initial approval for 53 (93%) of the vaccines was supported by randomized controlled trials, with a median cohort size of 4161 participants (interquartile range, 2204 to 8634 participants). There were 58 postapproval, safety-related label modifications associated with 25 vaccines (49 warnings and precautions, 8 contraindications, and 1 safety-related withdrawal). The initial approval trial characteristics were similar in vaccines with and without postmarketing, safety-related label modifications. The most common safety issue triggering label modifications was expansion of population restrictions (n = 21 [36%]), followed by allergies (n = 13 [22%]). The most common source of safety data was postmarketing surveillance (n = 28 of 58 [48%]). LIMITATION: The data source of the initial signal triggering safety-related label changes may not necessarily represent all safety data received and processed by the FDA. CONCLUSION: Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance. PRIMARY FUNDING SOURCE: None.

Convolutional Neural Networks in Predicting Nodal and Distant Metastatic Potential of Newly Diagnosed Non-Small Cell Lung Cancer on FDG PET Images.

OBJECTIVE. The purpose of this study was to assess, by analyzing features of the primary tumor with 18F-FDG PET, the utility of deep machine learning with a convolutional neural network (CNN) in predicting the potential of newly diagnosed non-small cell lung cancer (NSCLC) to metastasize to lymph nodes or distant sites. MATERIALS AND METHODS. Consecutively registered patients with newly diagnosed, untreated NSCLC were retrospectively included in a single-center study. PET images were segmented with local image features extraction software, and data were used for CNN training and validation after data augmentation strategies were used. The standard of reference for designation of N category was invasive lymph node sampling or 6-month follow-up imaging. Distant metastases developing during the study follow-up period were assessed by imaging (CT or PET/CT), in tissue obtained from new suspected sites of disease, and according to the treating oncologist's designation. RESULTS. A total of 264 patients with NSCLC participated in follow-up for a median of 25.2 months (range, 6-43 months). N category designations were available for 223 of 264 (84.5%) patients, and M category for all 264. The sensitivity, specificity, and accuracy of CNN for predicting node positivity were 0.74 ± 0.32, 0.84 ± 0.16, and 0.80 ± 0.17. The corresponding values for predicting distant metastases were 0.45 ± 0.08, 0.79 ± 0.06, and 0.63 ± 0.05. CONCLUSION. This study showed that using a CNN to analyze segmented PET images of patients with previously untreated NSCLC can yield moderately high accuracy for designation of N category, although this may be insufficient to preclude invasive lymph node sampling. The sensitivity of the CNN in predicting distant metastases is fairly poor, although specificity is moderately high.

Comparison of deep learning models for natural language processing-based classification of non-English head CT reports.

PURPOSE: Natural language processing (NLP) can be used for automatic flagging of radiology reports. We assessed deep learning models for classifying non-English head CT reports. METHODS: We retrospectively collected head CT reports (2011-2018). Reports were signed in Hebrew. Emergency department (ED) reports of adult patients from January to February for each year (2013-2018) were manually labeled. All other reports were used to pre-train an embedding layer. We explored two use cases: (1) general labeling use case, in which reports were labeled as normal vs. pathological; (2) specific labeling use case, in which reports were labeled as with and without intra-cranial hemorrhage. We tested long short-term memory (LSTM) and LSTM-attention (LSTM-ATN) networks for classifying reports. We also evaluated the improvement of adding Word2Vec word embedding. Deep learning models were compared with a bag-of-words (BOW) model. RESULTS: We retrieved 176,988 head CT reports for pre-training. We manually labeled 7784 reports as normal (46.3%) or pathological (53.7%), and 7.1% with intra-cranial hemorrhage. For the general labeling, LSTM-ATN-Word2Vec showed the best results (AUC = 0.967 ± 0.006, accuracy 90.8% ± 0.01). For the specific labeling, all methods showed similar accuracies between 95.0 and 95.9%. Both LSTM-ATN-Word2Vec and BOW had the highest AUC (0.970). CONCLUSION: For a general use case, word embedding using a large cohort of non-English head CT reports and ATN improves NLP performance. For a more specific task, BOW and deep learning showed similar results. Models should be explored and tailored to the NLP task.

A systematic review assessing the under-representation of elderly adults in COVID-19 trials.

BACKGROUND: Coronavirus disease (COVID-19) has caused a pandemic threatening millions of people worldwide. Yet studies specifically assessing the geriatric population are scarce. We aimed to examine the participation of elderly patients in therapeutic or prophylactic trials on COVID-19. METHODS: In this review, randomized controlled trials (RCTs; n = 12) comparing therapeutic or prophylactic interventions registered on preprint repositories and/or published since December 2019 were analyzed. We searched in PubMed, leading journals websites, and preprint repositories for RCTs and large observational studies. We aimed to describe the age of included patients, the presence of an upper age limit and of adjusted analyses on age, any exclusion criteria that could limit participation of elderly adults such as comorbidities, cognitive impairment, limitation of life expectancy; and the assessment of long-term outcomes such as the need of rehabilitation or institutionalization. Mean participant ages were reported and compared with observational studies. RESULTS: Twelve RCTs assessing drug therapy for COVID-19 were included. Mean age of patients included in RCTs was 56.3 years. An upper age limit was applied in three published trials (25%) and in 200/650 (31%) trials registered at clinicaltrials.gov . One trial reported a subgroup analysis in patients ≥65. Patients were excluded for liver-function abnormalities in eight trials, renal disease in six, cardiac disease or risk of torsade de pointes in five, and four for cognitive or mental criteria, which are frequent comorbidities in the oldest patients. Only three trials allowed a family member to provide consent. Patients enrolled in RCTs were on average 20 years younger than those included in large (n ≥ 1000) observational studies. Seven studies had as their primary outcome a clinical endpoint, but none reported cognitive, functional or quality of life outcomes or need for rehabilitation or long-term care facility placement. CONCLUSIONS: Elderly patients are clearly underrepresented in RCTs, although they comprise the population hardest hit by the COVID-19 pandemic. Long-term outcomes such as the need of rehabilitation or institutionalization were not reported. Future investigations should target specifically this vulnerable population.

Effect of PET/CT on the Management and Outcomes of Participants with Hodgkin and Aggressive Non-Hodgkin Lymphoma: A Multicenter Registry.

Purpose To determine the relationship of PET/CT staging to the management and outcomes of participants with apparent limited-stage (LS) Hodgkin lymphoma (HL) or aggressive non-HL (ANHL) treated with curative intent. Materials and Methods This prospective multicenter registry included 850 participants (467 men and 383 women; median age, 54.1 years) from nine centers who had LS HL or ANHL on the basis of clinical data and CT, or with equivocal CT for advanced stage, who were considered for curative-intent first-line therapy. Participants were recruited between May 1, 2013, and December 31, 2015. Pre-PET/CT treatment plan was compared with treatment provided. Survival and second-line therapy initiation were compared with an historical control pool staged by using CT alone. Administrative data sources were used to control for baseline characteristics. Outcomes were assessed by using adjusted Cox proportional hazards regression and propensity score matching. Results PET/CT helped to upstage 150 of 850 participants (17.6%). There was a change in planned therapy in 224 of 580 (38.6%) of participants after PET/CT. There was a lower 1-year mortality for participants with ANHL in the PET/CT versus CT cohort (hazard ratio, 0.63; 95% confidence interval: 0.40, 1.0; P < .05) and for those with LS at PET/CT compared with those with LS at CT (hazard ratio, 0.40; 95% confidence interval: 0.21, 0.74; P = .004). For participants with HL, no 1-year outcome difference was found (P = .16). Conclusion PET/CT helped to upstage approximately 18% of participants and planned management was frequently altered. Participants with aggressive non-Hodgkin lymphoma whose first-line therapy was guided by PET/CT had significantly better survival compared with participants whose treatment was guided by CT. © RSNA, 2018 Online supplemental material is available for this article. See also the editorial by Scott in this issue.

Comparison of MRI Sequences in Whole-Body PET/MRI for Staging of Patients With High-Risk Prostate Cancer.

OBJECTIVE: The purpose of this study is to investigate the diagnostic value of various MRI sequences used for whole-body (WB) 18F-fluorocholine (FCH) PET/MRI staging of patients with high-risk prostate cancer (PCa). SUBJECTS AND METHODS: This analysis is based on data from a prospective study that included 58 patients with untreated high-risk PCa who underwent integrated WB FCH PET/MRI (n = 10) or FCH PET/CT and WB MRI (n = 48). Metastatic sites were recorded. The standard of reference was histopathologic findings or clinical and imaging follow-up, or both. For each MRI sequence (Dixon T1-weighted, turbo inversion recovery magnitude, WB DWI, and gadolinium-enhanced T1-weighted volumetric interpolated breath-hold examination [VIBE]), acquisition time was recorded, and conspicuity of metastatic lesions was qualitatively assessed by two radiologists using a 4-point ordinal scale (0-3). RESULTS: Total WB acquisition times were 1 minute 25 seconds for Dixon T1-weighted, 15 minutes 7 seconds for turbo inversion recovery magnitude, 16 minutes 33 seconds for WB DWI, and 1 minute 28 seconds for gadolinium-enhanced T1-weighted VIBE. The lesion detection rates were 88.3% (68/77) for Dixon T1-weighted, 94.8% (73/77) for turbo inversion recovery magnitude, 95.2% (40/42) for WB DWI, and 97.4% (75/77) for gadolinium-enhanced T1-weighted VIBE sequences. Moderate or high conspicuity scores were assigned to 62.3% (48/77) of lesions for Dixon T1-weighted, 88.3% (68/77) of lesions for turbo inversion recovery magnitude, 90.5% (38/42) of lesions for WB DWI, and 92.2% (71/77) of lesions for gadolinium-enhanced T1-weighted VIBE sequences. Conspicuity of metastases on gadolinium-enhanced T1-weighted VIBE and WB DWI sequences was higher than that on Dixon T1-weighted sequences (p < 0.0001 and p = 0.0011, respectively). CONCLUSION: Metastases from prostate cancer are best detected at DWI or gadolinium-enhanced T1-weighted VIBE sequences. The most time-efficient sequence with the highest lesion detection rate and conspicuity is gadolinium-enhanced T1-weighted VIBE.

Immunosuppression reduction in liver and kidney transplant recipients with suspected bacterial infection: A multinational survey.

BACKGROUND: There is no consensus on the optimal management of immunosuppression during bacterial infections among solid organ transplant recipients. METHODS: A multicenter, cross-sectional survey, of high-volume kidney and liver transplant centers across US and Europe. Structured questionnaires including six multiple-choice questions concerning the management of immunosuppression during infection were distributed among 381 centers. RESULTS: A total of 124 (33%) centers fully completed the questionnaire: 67 liver, 57 kidney centers. Participating centers reported heterogenous approaches to immunosuppression management for all types of immunosuppressive drugs. Notably, kidney centers reported similar frequencies of either discontinuation (19%), continuation (19%), or dose reduction (17.5%) of antimetabolites; discontinuation only for life-threatening infection (17.5%) or case by case decisions (27%). Calcineurin inhibitors (CNI) management was heterogenous mostly among liver centers, with 8% discontinuing the CNI, 18% continuing, and 22% reducing dose. Heterogenous approaches to management of steroids and inhibitors of the mammalian target of rapamycin were also demonstrated. CONCLUSIONS: Immunosuppression management during bacterial infection is heterogenous in US and European centers. Immunosupression reduction (ISR) during infection is a common practice, though supported by limited evidence. Demonstrating high heterogeneity in the approach to ISR, together with the equivocal results of clinical studies, support consideration of an interventional clinical trial.

18F-Fluorocholine PET Whole-Body MRI in the Staging of High-Risk Prostate Cancer.

OBJECTIVE: The purpose of this study was to determine whether integrated 18F-fluorocholine (FCH) PET whole-body MRI (PET/WBMRI) depicts lymph node and distant metastases in patients with high-risk prostate cancer more frequently than does conventional staging. SUBJECTS AND METHODS: A prospective study included 58 patients with untreated high-risk prostate cancer. After conventional staging (CT and bone scintigraphy), patients underwent FCH PET/WBMRI (n = 10) or FCH PET/CT and WBMRI (n = 48). Metastatic sites and disease stage were recorded for each modality (conventional imaging, PET, WBMRI, and PET/WBMRI) and compared with a standard of reference (histopathologic examination, imaging, and clinical follow-up) and early clinical outcomes. RESULTS: In the detection of metastases, PET had significantly higher sensitivity (72/77 [93.5%]) than conventional imaging (49/77 [63.6%]; p < 0.001) and WBMRI (56/77 [72.7%]; p = 0.002). There was a trend toward improved detection with PET/WBMRI (77/77 [100%]) compared with PET alone (p = 0.059). For correct NM staging, PET and PET/WBMRI performed better than conventional imaging (p = 0.002) and WBMRI (p = 0.008). Twelve of 56 patients (21.4%) had early biochemical failure after radical treatment (median, 7 months; range, 1-20 months). This rate was higher for patients with M1a or M1b disease at PET/WBMRI than for others, but this finding did not reach statistical significance (4/8 [50%] vs 8/48 [16.7%]; p = 0.055). CONCLUSION: In patients with high-risk prostate cancer, FCH PET and FCH PET/WBMRI depict significantly more metastatic lesions than do conventional imaging and WBMRI. Stage determined with PET/WBMRI may correlate with early outcomes.

[18 F]-FDG PET/CT in the staging and management of indolent lymphoma: A prospective multicenter PET registry study.

BACKGROUND: To measure the clinical impact of pretreatment fludeoxyglucose positron emission tomography/computed tomography (PET/CT) on the staging and management of apparent limited stage indolent lymphoma being considered for curative radiation therapy. METHODS: We conducted a prospective multicenter registry study that included 197 patients accrued between May 1, 2012, and December 31, 2015. Pre-PET/CT stage, determined by clinical and CT data, was documented. If pre-PET/CT stage was indeterminate, a stage was assigned to the patient by the referring oncologist according to best clinical judgment and treatment intent. After PET/CT, revised stage and planned management were recorded and compared with data on actual treatment received available through provincial databases (n = 155). RESULTS: PET/CT resulted in the upstaging of 47 (23.9%) patients with presumed limited stage disease (stage I-II) to advanced stage disease (stage III-IV) (P < .0001). Ten (5.1%) patients were downstaged by PET/CT, 4 of whom migrated from advanced to limited stage disease. Twenty-eight (14.2%) patients with a specific pre-PET/CT stage had equivocal PET/CT findings that required further evaluation to confirm disease extent. After PET/CT, 95 (61.3%) patients were planned to receive active treatment. Of the 59 patients planned for radiotherapy alone post-PET/CT, 34 (57.6%) received this treatment (P = .002), and nearly 80% of them (n = 27) had confirmed limited stage disease. CONCLUSION: PET/CT has a significant impact on staging and management in patients with apparent limited stage indolent lymphoma who are being considered for curative radiotherapy. PET/CT should be routinely incorporated into the workup of these patients. Cancer 2017;123:2860-66. © 2017 American Cancer Society.