Lawrence H Schwartz

Johns Hopkins Medicine, Baltimore, Maryland, United States

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Publications (352)

  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: Mediastinal nodal (N)-staging done by integrated 2-deoxy-2-[(18)F]fluoro-D-glucose ([(18)F]FDG) positron emission tomography/x-ray computed tomography (PET/CT) in lung cancer patients is not always accurate. In order to reduce the need for invasive staging procedures, additional surrogate parameters for the detection of malignant lymph node infiltration would be helpful. The purpose of this study was to evaluate if radiomic semi-automated density profiling in mediastinal lymph nodes can improve preclinical N-staging, irrespective of the specific lung cancer entity. Procedures: This retrospective study was approved by the institutional review board. Two hundred forty-eight histologically proven lymph nodes in 122 lung cancer patients were investigated. In malignantly infiltrated lymph nodes, the specific lung cancer entity was histologically classified; benign lymph nodes were histologically classified as benign. Non-contrast enhanced [(18)F]FDG-PET/CT was performed before surgery/biopsy. Lymph node analyses were performed on the basis of FDG uptake and volumetric CT histogram analysis for metric lymph node sampling. Results: Of the 248 lymph nodes, 118 were benign, 130 malignant. Malignant lymph nodes had a significantly higher median CT density (32.4 Hounsfield units (HU) (min 5.4/max 77.5 HU)) compared to benign lymph nodes (9.3 HU (min -49.5/max 60.4 HU, p < 0.05), irrespective of the histological subtype. The discrimination between different malignant tumour subtypes by means of volumetric density analysis failed. Irrespective of the malignant subtype, a possible cutoff value of 20 HU may help differentiate between benign and malignant lymph nodes. Conclusion: Density measurements in unclear mediastinal and hilar lymph nodes with equivocal FDG uptake in PET might serve as a possible surrogate parameter for N-staging in lung cancer patients, irrespective of the specific lung cancer subtype. This could also help to find possible high yield targets in cases where invasive lymph node staging is necessary.
    Article · Aug 2016 · Molecular Imaging & Biology
  • Lawrence H. Schwartz · Lesley Seymour · Saskia Litière · [...] · Elisabeth de Vries
    [Show abstract] [Hide abstract] ABSTRACT: Radiologic imaging of disease sites plays a pivotal role in the management of patients with cancer. Response Evaluation Criteria in Solid Tumours (RECIST), introduced in 2000, and modified in 2009, has become the de facto standard for assessment of response in solid tumours in patients on clinical trials. The RECIST Working Group considers the ability of the global oncology community to implement and adopt updates to RECIST in a timely manner to be critical. Updates to RECIST must be tested, validated and implemented in a standardised, methodical manner in response to therapeutic and imaging technology advances as well as experience gained by users. This was the case with the development of RECIST 1.1, where an expanded data warehouse was developed to test and validate modifications. Similar initiatives are ongoing, testing RECIST in the evaluation of response to non-cytotoxic agents, immunotherapies, as well as in specific diseases. The RECIST Working Group has previously outlined the level of evidence considered necessary to formally and fully validate new imaging markers as an appropriate end-point for clinical trials. Achieving the optimal level of evidence desired is a difficult feat for phase III trials; this involves a meta-analysis of multiple prospective, randomised multicentre clinical trials. The rationale for modifications should also be considered; the modifications may be proposed to improve surrogacy, to provide a more mechanistic imaging technique, or be designed to improve reproducibility of the imaging biomarker. Here, we present the commonly described modifications of RECIST, each of which is associated with different levels of evidence and validation.
    Article · May 2016 · European journal of cancer (Oxford, England: 1990)
  • Lawrence H. Schwartz · Saskia Litière · Elisabeth de Vries · [...] · Lesley Seymour
    [Show abstract] [Hide abstract] ABSTRACT: The Response Evaluation Criteria in Solid Tumours (RECIST) were developed and published in 2000, based on the original World Health Organisation guidelines first published in 1981. In 2009, revisions were made (RECIST 1.1) incorporating major changes, including a reduction in the number of lesions to be assessed, a new measurement method to classify lymph nodes as pathologic or normal, the clarification of the requirement to confirm a complete response or partial response and new methodologies for more appropriate measurement of disease progression. The purpose of this paper was to summarise the questions posed and the clarifications provided as an update to the 2009 publication.
    Article · May 2016 · European journal of cancer (Oxford, England: 1990)
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    Binsheng Zhao · Yongqiang Tan · Wei-Yann Tsai · [...] · Lawrence H. Schwartz
    Full-text Dataset · Mar 2016
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    Binsheng Zhao · Yongqiang Tan · Wei-Yann Tsai · [...] · Lawrence H. Schwartz
    [Show abstract] [Hide abstract] ABSTRACT: Radiomics (radiogenomics) characterizes tumor phenotypes based on quantitative image features derived from routine radiologic imaging to improve cancer diagnosis, prognosis, prediction and response to therapy. Although radiomic features must be reproducible to qualify as biomarkers for clinical care, little is known about how routine imaging acquisition techniques/parameters affect reproducibility. To begin to fill this knowledge gap, we assessed the reproducibility of a comprehensive, commonly-used set of radiomic features using a unique, same-day repeat computed tomography data set from lung cancer patients. Each scan was reconstructed at 6 imaging settings, varying slice thicknesses (1.25 mm, 2.5 mm and 5 mm) and reconstruction algorithms (sharp, smooth). Reproducibility was assessed using the repeat scans reconstructed at identical imaging setting (6 settings in total). In separate analyses, we explored differences in radiomic features due to different imaging parameters by assessing the agreement of these radiomic features extracted from the repeat scans reconstructed at the same slice thickness but different algorithms (3 settings in total). Our data suggest that radiomic features are reproducible over a wide range of imaging settings. However, smooth and sharp reconstruction algorithms should not be used interchangeably. These findings will raise awareness of the importance of properly setting imaging acquisition parameters in radiomics/radiogenomics research.
    Full-text Article · Mar 2016 · Scientific Reports
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    [Show abstract] [Hide abstract] ABSTRACT: Hypothesis: Many patients with lung cancers cannot receive platinum-containing regimens due to co-morbid medical conditions. We designed the PPB regimen of paclitaxel, pemetrexed, and bevacizumab to maintain or improve outcomes while averting the unique toxicities of platinum-based chemotherapies. Methods: We enrolled patients with untreated, advanced lung adenocarcinomas with measurable disease, and no contraindications for bevacizumab. Participants received paclitaxel 90 mg/m(2), pemetrexed 500 mg/m(2), and bevacizumab 10 mg/kg every 14 days for six months and continued pemetrexed and bevacizumab every 14 days until progression or unacceptable toxicity. Results: Forty-four patients were treated: 50% women, median age 61 years, and 89% with Karnofsky performance status ≥80%. We genotyped 38 patients: KRAS 16; ALK 3; BRAF V600E 2; HER2/PIK3CA 1; EGFR exon 20 insertion 1; no driver 15. 23 patients achieved a partial response (52%, 95% CI 37 to 68%), including 7/16 with KRAS-mutant tumors. Overall survival at two years was 43% with a median of 17 months (95% CI, 10 to 29). Grade 3/4 treatment-related toxicities included elevated ALT (16%); fatigue (16%); leukopenia (9%); anemia (7%); elevated AST (7%); edema (5%) and pleural effusions (5%). Two patients died of respiratory failure without disease progression. Conclusions: The PPB regimen of paclitaxel, pemetrexed, and bevacizumab produced a high response rate in patients with lung adenocarcinomas, regardless of mutational status. Survival and toxicities were comparable to phase II reports testing platinum-containing doublets with bevacizumab. These results justify use of the PPB regimen in fit patients where 3 drug regimens including bevacizumab are appropriate.
    Full-text Article · Mar 2016 · Journal of thoracic oncology: official publication of the International Association for the Study of Lung Cancer
  • Geoffrey R Oxnard · Katharine H Wilcox · Mithat Gonen · [...] · Lawrence H Schwartz
    [Show abstract] [Hide abstract] ABSTRACT: Importance: Objective response rate (ORR) is an increasingly important end point for accelerated development of highly active anticancer therapies, yet its relationship to regulatory approval is not well characterized. Objective: To identify circumstances in which a high ORR is associated with regulatory approval, and therefore might be an appropriate end point for definitive single-arm studies of anticancer therapies. Data source: A database of all oncology clinical trials registered at between October 1, 2007, and September 30, 2010. Study selection: Trials of palliative systemic therapies for 4 measurable solid tumor types, limited to those with trial arms of at least 20 patients reporting ORR per Response Evaluation Criteria in Solid Tumors (RECIST). Data extraction and synthesis: A systematic search was used to identify the reported ORR for each eligible treatment arm that had been presented publicly. Main outcomes and measures: For each treatment regimen, defined as a single-agent or unique combination of agents for 1 cancer type, the mean ORR and the maximum ORR statistically exceeded were calculated, and their association with regulatory approval was studied. A regimen was considered approved for a specific cancer type if it had received regulatory approval in any country for treatment of advanced cancer of that type. Results: From 1800 trials, 874 eligible trial arms in 578 eligible trials were identified; 542 arms had ORR data available for 294 regimens. Maximum ORR and mean ORR were significantly associated with regulatory approval (τ = 0.27, P < .001; τ = 0.12, P = .01); this relationship was stronger for single-agent therapies (τ = 0.49; τ = 0.41) than for combination regimens (τ = 0.28; τ = 0.17). Evaluation of ORR thresholds between 20% and 60% as potential trial end points demonstrated that ORR statistically exceeding 30% with a single agent had 98% specificity and 89% positive predictive value for identifying regimens achieving regulatory approval. Conclusions and relevance: For single-agent regimens, high ORR was associated with regulatory approval; this relationship was less strong for combination regimens. Our data suggest that high ORR (eg, statistically exceeding an ORR of 30%) is an appropriate end point for single-arm trials aiming to demonstrate breakthrough activity of a single-agent anticancer therapy.
    Article · Feb 2016
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: Evolving treatments, disease phenotypes, and biology, together with a changing drug development environment, have created the need to revise castration-resistant prostate cancer (CRPC) clinical trial recommendations to succeed those from prior Prostate Cancer Clinical Trials Working Groups. Methods: An international expert committee of prostate cancer clinical investigators (the Prostate Cancer Clinical Trials Working Group 3 [PCWG3]) was reconvened and expanded and met in 2012-2015 to formulate updated criteria on the basis of emerging trial data and validation studies of the Prostate Cancer Clinical Trials Working Group 2 recommendations. Results: PCWG3 recommends that baseline patient assessment include tumor histology, detailed records of prior systemic treatments and responses, and a detailed reporting of disease subtypes based on an anatomic pattern of metastatic spread. New recommendations for trial outcome measures include the time to event end point of symptomatic skeletal events, as well as time to first metastasis and time to progression for trials in the nonmetastatic CRPC state. PCWG3 introduces the concept of no longer clinically benefiting to underscore the distinction between first evidence of progression and the clinical need to terminate or change treatment, and the importance of documenting progression in existing lesions as distinct from the development of new lesions. Serial biologic profiling using tumor samples from biopsies, blood-based diagnostics, and/or imaging is also recommended to gain insight into mechanisms of resistance and to identify predictive biomarkers of sensitivity for use in prospective trials. Conclusion: PCWG3 moves drug development closer to unmet needs in clinical practice by focusing on disease manifestations most likely to affect prognosis adversely for therapeutics tested in both nonmetastatic and metastatic CRPC populations. Consultation with regulatory authorities is recommended if a trial is intended to seek support for drug approval.
    Article · Feb 2016 · Journal of Clinical Oncology
  • [Show abstract] [Hide abstract] ABSTRACT: Purpose: Transarterial chemoembolization is accepted therapy for hepatocellular carcinoma (HCC). No randomized trial has demonstrated superiority of chemoembolization compared with embolization, and the role of chemotherapy remains unclear. This randomized trial compares the outcome of embolization using microspheres alone with chemoembolization using doxorubicin-eluting microspheres. Materials and methods: At a single tertiary referral center, patients with HCC were randomly assigned to embolization with microspheres alone (Bead Block [BB]) or loaded with doxorubicin 150 mg (LC Bead [LCB]). Random assignment was stratified by number of embolizations to complete treatment, and assignments were generated by permuted blocks in the institutional database. The primary end point was response according to RECIST 1.0 (Response Evaluation Criteria in Solid Tumors) using multiphase computed tomography 2 to 3 weeks post-treatment and then at quarterly intervals, with the reviewer blinded to treatment allocation. Secondary objectives included safety and tolerability, time to progression, progression-free survival, and overall survival. This trial is currently closed to accrual. Results: Between December 2007 and April 2012, 101 patients were randomly assigned: 51 to BB and 50 to LCB. Demographics were comparable: median age, 67 years; 77% male; and 22% Barcelona Clinic Liver Cancer stage A and 78% stage B or C. Adverse events occurred with similar frequency in both groups: BB, 19 of 51 patients (38%); LCB, 20 of 50 patients (40%; P = .48), with no difference in RECIST response: BB, 5.9% versus LCB, 6.0% (difference, -0.1%; 95% CI, -9% to 9%). Median PFS was 6.2 versus 2.8 months (hazard ratio, 1.36; 95% CI, 0.91 to 2.05; P = .11), and overall survival, 19.6 versus 20.8 months (hazard ratio, 1.11; 95% CI, 0.71 to 1.76; P = .64) for BB and LCB, respectively. Conclusion: There was no apparent difference between the treatment arms. These results challenge the use of doxorubicin-eluting beads for chemoembolization of HCC.
    Article · Feb 2016 · Journal of Clinical Oncology
  • [Show abstract] [Hide abstract] ABSTRACT: Methods: (18)F-FDG PET images at baseline and approximately 9 days after initiation of IGF-1R antibody therapy in 115 patients with refractory or relapsed ESFT were prospectively obtained as part of the Sarcoma Alliance for Research through Collaboration trial (SARC-11). Responses were centrally evaluated by PET response criteria in solid tumors (PERCIST) 1.0 in 93 patients. The 9 day PET responses were correlated to overall survival (OS), progression free survival (PFS), and clinical benefit after 6 weeks of therapy based on clinical observation and CT response by WHO anatomic criteria. Results: The median OS was 8.1 months (95% CI, 6.4 to 10.0 months). Using PERCIST, patients with progressive metabolic disease (PMD) showed shorter OS (median 4.7 months) compared to patients without progression (median 10.0 months, P = 0.001). PMD on day 9 PET was associated with a significantly higher risk of death (hazard ratio=2.8; 95% CI, 1.5 to 5.5). Changes in (18)F-FDG uptake after 9 days of therapy had an area under the curve (AUC) of receiver operating characteristic of 0.71 to predict 1 year OS. The AUC was 0.63 to predict progression at 3 months, and was 0.79 to predict clinical benefit after 6 weeks of therapy. Conclusion: Treatment response by quantitative (18)F-FDG PET assessed by PERCIST 1.0 as early as 9 days into IGF-1R antibody therapy in patients with ESFT can predict the OS, PFS, and clinical response to therapy.
    Article · Jan 2016 · Journal of Nuclear Medicine
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    Thomas E Yankeelov · David A Mankoff · Lawrence H Schwartz · [...] · Daniel L Rubin
    [Show abstract] [Hide abstract] ABSTRACT: As anticancer therapies designed to target specific molecular pathways have been developed, it has become critical to develop methods to assess the response induced by such agents. Although traditional, anatomic CT, and MRI examinations are useful in many settings, increasing evidence suggests that these methods cannot answer the fundamental biologic and physiologic questions essential for assessment and, eventually, prediction of treatment response in the clinical trial setting, especially in the critical period soon after treatment is initiated. To optimally apply advances in quantitative imaging methods to trials of targeted cancer therapy, new infrastructure improvements are needed that incorporate these emerging techniques into the settings where they are most likely to have impact. In this review, we first elucidate the needs for therapeutic response assessment in the era of molecularly targeted therapy and describe how quantitative imaging can most effectively provide scientifically and clinically relevant data. We then describe the tools and methods required to apply quantitative imaging and provide concrete examples of work making these advances practically available for routine application in clinical trials. We conclude by proposing strategies to surmount barriers to wider incorporation of these quantitative imaging methods into clinical trials and, eventually, clinical practice. Our goal is to encourage and guide the oncology community to deploy standardized quantitative imaging techniques in clinical trials to further personalize care for cancer patients and to provide a more efficient path for the development of improved targeted therapies. Clin Cancer Res; 22(2); 284-90. ©2016 AACR.
    Full-text Article · Jan 2016 · Clinical Cancer Research
  • Article · Jan 2016 · Radiology
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    [Show abstract] [Hide abstract] ABSTRACT: J591 is a monoclonal antibody that targets the external domain of the prostate-specific membrane antigen (PSMA). Besides prostate cancer cells, it also targets the neovasculature of non-prostate solid tumors. We provide an analysis of the antibody mass-dose dependency of lesion uptake and normal tissue retention, together with an assessment of lesion detectability using (111)In-J591 imaging, compared with conventional imaging in patients with a variety of solid tumors. Twenty patients in six cohorts received fixed amounts (5, 10, 20, 40, 60, and 100 mg) of J591 in a phase I trial. A maximum of four administrations per patient was given, with each administration separated by 3 weeks. All antibody administrations included 370 MBq (10 mCi) of (111)In labeled to 2 mg of J591 via the chelating agent DOTA. Three whole body (WB) gamma camera scans with at least one SPECT scan, along with multiple WB count-rate measurements and blood samples, were obtained for all patients. The effect of escalating antibody mass on lesion uptake and normal tissue retention was evaluated using lesion, liver, serum, and WB residence times and ratios thereof for each treatment cycle. Lesion detectability using (111)In-J591 imaging was compared to the standard imaging on a lesion-by-lesion basis. A total of 170 lesions in 20 patients were detected by standard or (111)In-J591 imaging. (111)In-J591 targeted both skeletal and soft tissue diseases in all tumor types. (111)In-J591 imaging identified 74% (20/27) of skeletal lesions, 53% (18/34) of nodes, and 64% (70/109) of other soft tissue/organ lesions. There was increasing (111)In-J591 uptake in lesions with increasing antibody mass-dose, coupled with decreasing retention in the liver for increments up to 20 mg, and no significant change at higher antibody mass. Radiolabeled J591 antibody has potential as a targeting agent for solid tumor vasculature and lesion detection. Bone and soft tissue lesions arising from tumors of diverse origin were targeted by the anti-PSMA antibody J591. For the detection of lesions in these tumors by J591 antibody scans, an antibody mass of 20 mg is adequate. The optimal time of imaging is 5 to 7 days post-injection.
    Full-text Article · Dec 2015 · EJNMMI Research
  • Jiayong Yan · Lawrence H. Schwartz · Binsheng Zhao
    [Show abstract] [Hide abstract] ABSTRACT: Purpose: Accurate segmentation and quantification of liver metastases on CT images are critical to surgery/radiation treatment planning and therapy response assessment. To date, there are no reliable methods to perform such segmentation automatically. In this work, the authors present a method for semiautomatic delineation of liver metastases on contrast-enhanced volumetric CT images.
    Article · Nov 2015 · Medical Physics
  • Emily C Zabor · Glenn Heller · Lawrence H Schwartz · Paul B Chapman
    [Show abstract] [Hide abstract] ABSTRACT: Purpose: Surrogate endpoints are needed that correlate with overall survival (OS). We analyzed individual patient tumor data from a phase III trial of vemurafenib vs. dacarbazine (BRIM3) to identify criteria for tumor measures that correlated with OS. Correlates were validated using a separate data set from a phase II trial of vemurafenib (BRIM2). Experimental design: De-identified tumor measurements and OS data from BRIM3 and from BRIM2 were analyzed. Target tumor measurement data and non-target tumor data were available from pretreatment, weeks 6,12, and every 9 weeks thereafter. In the BRIM3 data set, associations of OS with both early tumor response (first 12 weeks) and time to progression (TTP) were assessed. Different definitions of response and progression were explored. Findings were validated using the BRIM2 data set. Results: Thresholds of early response were explored ranging from any degree of tumor shrinkage to 100% tumor shrinkage. Correlation was weak at all thresholds tested. TTP, however, was more strongly correlated with OS. The strongest correlation was seen when progression was defined as ≥50% increase in the sum of tumor diameters or appearance of new tumors. This was confirmed by similar analyses in the BRIM2 cohort. Conclusions: TTP defined as ≥50% increase in the sum of tumor diameters or appearance of new tumors was more strongly associated with OS than early tumor shrinkage in melanoma patients treated with RAF inhibitor. In future trials, consideration should be given to replacing response rate with TTP or PFS as preferable clinical endpoints in early phase studies.
    Article · Oct 2015 · Clinical Cancer Research
  • Lin Lu · Yongqiang Tan · Lawrence H. Schwartz · Binsheng Zhao
    [Show abstract] [Hide abstract] ABSTRACT: The diversity of lung nodules poses difficulty for the current computer-aided diagnostic (CAD) schemes for lung nodule detection on computed tomography (CT) scan images, especially in large-scale CT screening studies. We proposed a novel CAD scheme based on a hybrid method to address the challenges of detection in diverse lung nodules. The hybrid method proposed in this paper integrates several existing and widely used algorithms in the field of nodule detection, including morphological operation, dot-enhancement based on Hessian matrix, fuzzy connectedness segmentation, local density maximum algorithm, geodesic distance map, and regression tree classification. All of the adopted algorithms were organized into tree structures with multi-nodes. Each node in the tree structure aimed to deal with one type of lung nodule. The method has been evaluated on 294 CT scans from the Lung Image Database Consortium (LIDC) dataset. The CT scans were randomly divided into two independent subsets: a training set (196 scans) and a test set (98 scans). In total, the 294 CT scans contained 631 lung nodules, which were annotated by at least two radiologists participating in the LIDC project. The sensitivity and false positive per scan for the training set were 87% and 2.61%. The sensitivity and false positive per scan for the testing set were 85.2% and 3.13%. The proposed hybrid method yielded high performance on the evaluation dataset and exhibits advantages over existing CAD schemes. We believe that the present method would be useful for a wide variety of CT imaging protocols used in both routine diagnosis and screening studies.
    Article · Sep 2015 · Medical Physics
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    Full-text Article · Aug 2015 · Journal of Clinical Oncology
  • Michel Meignan · Martin Hutchings · Lawrence H Schwartz
    Article · Jul 2015 · The Oncologist
  • Vadim S. Koshkin · Vanessa Bolejack · Lawrence H. Schwartz · [...] · Laurence H. Baker
    Conference Paper · May 2015
  • [Show abstract] [Hide abstract] ABSTRACT: To compare lesion conspicuity in patients with liver metastases arising from gastroenteropancreatic neuroendocrine tumors (GEP-NETs) using MRI, PET and CT. 16 patients with GEP-NETs were evaluated using non-contrast MRI, contrast-enhanced (CE) MRI using Gd-EOB-DTPA and CE-(68)Ga-DOTATOC PET. Quantitative analyses were performed by two blinded readers using ROI-analyses quantifying contrast ratios (CR) between normal liver-tissue and GEP-NET-metastases. Qualitative analyses were performed evaluating primary visibility and spatial detectability of all lesions. 103 of the same liver metastases were detected on all modalities. Qualitatively, lesion conspicuity was superior on CE-MRI imaging compared to non-contrast MR-sequences (T2, DWI, fl2D, fl3D), as well as arterial- and portal-venous phase CT. Concerning detectability of lesions, CE-MRI was superior to all other modalities. The quantitative ROI-analysis demonstrated improved CR for DWI compared to all other non-contrast MR-sequences (p<0.001). CE-MRI presented with higher CR-values compared to CE-(68)Ga-DOTATOC PET/CT (p<0.001). Anatomic imaging using non contrast MRI with fl2D-and fl3D-sequences in combination with the molecular imaging modality (68)Ga-DOTATOC PET is optimal for the assessment of liver lesions in GEP-NET-patients. Even though CE-MRI was superior to non-contrast MRI, non-contrast MRI is sufficient to detect and quantify liver metastases in daily routine, especially in combination with DW-Imaging. Copyright © 2015. Published by Elsevier Ireland Ltd.
    Article · May 2015 · European journal of radiology

Publication Stats

23k Citations


  • 2016
    • Johns Hopkins Medicine
      Baltimore, Maryland, United States
  • 2013-2015
    • Columbia University
      • College of Physicians and Surgeons
      New York, New York, United States
  • 2002-2010
    • Cornell University
      • Department of Medicine
      Итак, New York, United States
  • 2007
    • University of Cologne
      Köln, North Rhine-Westphalia, Germany
  • 2006
    • Memorial Sloan-Kettering Cancer Center
      • Department of Radiology
      New York City, New York, United States
    • Johns Hopkins University
      Baltimore, Maryland, United States