Chen 2010.
Study characteristics | |||
Patient sampling | Prospective consecutive patient series | ||
Patient characteristics and setting | 56 participants, mean age = 51 (range = 35 to 76) years, 35 males/21 females, China Histology of primary tumour Not reported. comorbidities: not reported Inclusion criteria Quote: "From January to March in 2008, 56 consecutive participants with NSCLC underwent WB‐DWI and integrated FDG PET/CT for primary tumor, lymph node metastasis and distant metastasis." No further information reported Exclusion criteria Not reported Previous/all reported tests See Inclusion criteria. No further information reported Clinical setting Department of Radiology |
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Index tests | All participants fasted for at least 4 to 6 hours, and normal blood glucose levels were verified on blood samples collected before intravenous administration of FDG at a rate of 3.3 MBq/kg. PET‐CT images were obtained from the skull to the mid thigh 60 min after completion of injection. PET‐CT imaging was conducted by using the Biograph mMR system, which consisted of a PET scanner (Siemens Medical Solutions, Hoffman Estates, IL, USA) and a 2‐section CT scanner (Siemens Medical Solutions, Erlangen, Germany). PET data were collected with a full‐ring PET tomography. The PET component of the Biograph mMR had an in‐plane spatial resolution of 4.6 mm and a transverse field of view of 15.5 cm for 1 table position. After unenhanced CT was performed, emission PET was performed in the identical transverse field of view. The system generated separate CT and PET data sets that could be fused by using a syngo‐based fusion tool (Siemens Medical Solutions, Erlangen, Germany). The whole PET/CT study took approximately 45 min. All FDG‐PET‐CT studies were independently reviewed by 2 nuclear medicine physicians, who were also blinded to all information about the results of whole‐body MR and conventional radiologic examinations Covariates Type of PET‐CT scanner: Biograph system (Siemens). FDG dose: 3.3 MBq/kg Injection‐to‐scan time: 60 min Attenuation correction: probably, but not explicitly reported Cut‐off values for test positivity (malignancy): (quote (author communication)) "The criteria for test positivity on PET‐CT is visually more metabolically active than mediastinal blood pool" |
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Target condition and reference standard(s) | All primary tumours were diagnosed on the basis of pathologic results from endoscopic CT‐guided or surgical biopsies. The metastastic sites were determined on the basis of the results of CT, integrated FDG PET‐CT, and MR examinations. The diagnosis of a lesion as metastasis was determined either by pathology or follow‐up. (The lesion became larger during the follow‐up periods or decreased in size after treatment.) The follow‐up was maintained for more than 6 months in every participant, and the diameters of suspect (?) lymph nodes (>10 mm) were consecutively observed; if no change in size was observed during the period, then a diagnosis as nonmetastatic lymph nodes was made. | ||
Flow and timing | It is unclear how many participants received pathological confirmation of their N status and how many received follow‐up as the reference standard | ||
Comparative | |||
Notes | Funding: no details reported Adverse events: not reported |
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Methodological quality | |||
Item | Authors' judgement | Risk of bias | Applicability concerns |
DOMAIN 1: Patient Selection | |||
Was a consecutive or random sample of patients enrolled? | Yes | ||
Was a case‐control design avoided? | Yes | ||
Did the study avoid inappropriate exclusions? | Unclear | ||
Unclear | Low | ||
DOMAIN 2: Index Test All tests | |||
Were the index test results interpreted without knowledge of the results of the reference standard? | Yes | ||
Was there a pre‐specified cut‐off value? | No | ||
Was a positive result defined? | No | ||
Unclear | Low | ||
DOMAIN 3: Reference Standard | |||
Is the reference standards likely to correctly classify the target condition? | Yes | ||
Were the reference standard results interpreted without knowledge of the results of the index tests? | No | ||
Unclear | Low | ||
DOMAIN 4: Flow and Timing | |||
Was there an appropriate interval between index test and reference standard? | Unclear | ||
Did all patients receive the same reference standard? | Unclear | ||
Were all patients included in the analysis? | No | ||
Unclear |