Fischer 2011.
Study characteristics | |||
Patient sampling | Prospective random patient series | ||
Patient characteristics and setting | 98 participants, mean age = 62 (range = 42 to 80) years, 53 males/45 females, Denmark Histology of primary tumour Adenocarcinoma: N = 29; squamous cell: N = 20; large cell: N = 4; NSCLC other: N = 7; comorbidities: not reported Inclusion criteria Participants between 18 and 80 years with newly diagnosed NSCLC that was considered operable after conventional staging procedures Exclusion criteria Type 1 diabetes, another malignant condition, confirmed distant metastases, known claustrophobia, and an estimated forced expiratory volume in 1 second of less than 30% after surgery Previous/all reported tests CT then FDG‐PET/CT followed by invasive diagnostic procedures. Standard staging procedures were governed by local routine based on current guidelines; however, mediastinoscopy was considered mandatory Clinical setting Departments of Pulmonology |
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Index tests | After a 6‐hour fast, 400 MBq of (¹⁸F)‐2‐fluoro‐deoxy‐D‐glucose (FDG) was given intravenously, and after a 1‐hour rest, the participantwas scanned from the head to the upper thigh with the use of an integrated PET–CT system (GE Discovery LS, GE Healthcare). A diagnostic CT scan, obtained with the use of a standard protocol (80 to 100 mA, 120 kV, a tube‐rotation time of 0.5 second per rotation, a pitch of 6, and a slice thickness of 5 mm, with 70 ml of intravenous contrast medium containing 300 mg of iodine per millilitre (Ultravist, Bayer Schering), administered at a rate of 2.5 ml per second), preceded the PET scan (a 5‐minute emission scan per table position and 25 minutes total). The PET scan was reconstructed by filtered back‐projection and ordered‐subset expectation‐maximisation (OS‐EM), with data from the CT scan used for attenuation correction. An experienced radiologist and a nuclear medicine specialist evaluated the FDG‐PET/CT images side by side, and a consensus was reached on the findings Covariates Type of PET‐CT scanner: integrated PET‐CT scanner (Discovery LS; GE Healthcare) FDG dose: 400 MBq Injection‐to‐scan time: 60 min Attenuation correction: yes Cut‐off values for test positivity (malignancy): A lesion with increased uptake of FDG in 3 planes when compared with background on a PET scan was classified as malignant. If the image could not be interpreted with confidence, the SUV, defined as the activity per ml within the region of interest divided by the injected dose in megabecquerels per gram of body weight, was calculated, and lesions with a SUV > 2.5 were deemed malignant |
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Target condition and reference standard(s) | Thoracotomy: N = 60; mediastinoscopy: N = 9; EUS‐FNA: N = 19; EBUS‐TBNA: N = 4; not applicable: N = 6, as N = 4 had M1 disease, N = 1 had inoperable T4, and N = 1 was N0 or N1, but considered inoperable because of coexisting disease | ||
Flow and timing | All participants were accounted for in the results. 14/98 participants did not receive FDG PET‐CT, and 5 participants did not receive the reference standard. Total N reported in the results was therefore = 79 | ||
Comparative | |||
Notes | Funded by the Danish Cancer Society and the Danish Center for Health Technology. The authors stated that the study was subject to no competing interests 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? | Yes | ||
Low | 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? | Yes | ||
Was a positive result defined? | Yes | ||
Low | 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? | Unclear | ||
Low | 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? | Yes | ||
Were all patients included in the analysis? | No | ||
Unclear |