Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03272997 |
| Other study ID # |
PET-CT in UPE |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 1, 2017 |
| Est. completion date |
January 30, 2019 |
Study information
| Verified date |
December 2020 |
| Source |
Naestved Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The investigators aim is to asses the diagnostic power of 18F-FDG PET-CT in discriminating
malignant from nonmalignant causes in patients with a recurrent unilateral pleural effusion
of unknown origin.
Description:
The investigators follow the STARD 2015 guideline for reporting diagnostic accuracy studies.
The investigators will review the hospital's administrative database of patients who
underwent a thoracocentesis from January 2013 to January 2015. Patients at Department of
Respiratory Medicine, Zealand University Hospital, Roskilde and Department of Respiratory
Medicine, Naestved Hospital, Region Zealand, Denmark (two large respiratory centres with
specialised functions) is eligible for inclusion. Patients are included irrespective of
cytology and chemical analysis.
The investigators will review the patients' medical records and images retrospectively. To
reduce the number of false negatives, the investigators complete a 1-year follow-up.
Patients older than 16 years are included, irrespective of smoking history and comorbidities,
if both thoracocenteses, chest x-ray, a CT-scanning and a PET-CT scanning is performed.
Exclusion criteria are previously diagnosed lung cancer, thoracic malignancy or incomplete
data.
Classification of results The investigators chose the combination of investigations
recommended by the internationally acknowledged BTS guideline, which is endorsed by the
Danish Society of Respiratory Medicine. Thoracocentesis, chest x-ray, CT findings and PET-CT
findings is categorized as either normal (i.e. not suggestive of any aetiology of the
unilateral pleural effusion), suggestive of other lung pathology or suggestive of malignancy
(i.e. representing a possible aetiology of the unilateral pleural effusion).
The thoracocentesis is classified as malignant if cytological examination revealed malignant
cells. The chest x-ray is classified as malignant if suspicion of malignant disease is not
rejected. The CT findings are classified as malignant according to Leung et. al. for pleural
abnormalities (circumferential pleural thickening, nodular pleural thickening, parietal
pleural thickening > 1 cm and mediastinal pleural involvement) and The Fleischner Society for
parenchymal abnormalities (nodules > 8 mm). The PET-CT findings are classified as malignant
if any findings suspicious for malignancy.
CT and PET-CT images, as well as the scan reports by the radiologist and the nuclear medicine
physician, is reviewed by two experienced pulmonologists. They are blinded to all patient
information, including final diagnosis.
The final diagnosis, the reference standard, is extracted from the patients' medical records.
When no diagnosis is found, two investigators agree on a consensus diagnosis based on all
investigation results. If no reasonable diagnosis can be established based on the findings,
the patient case is categorized as having no final diagnosis. These cases are treated as a
worst-case scenario, i.e. patients with a malignant disease are treated as false negative,
and patients without malignant disease are treated as false positive.
Statistics Data are presented as frequencies and/or mean ± standard deviation (SD). Test
characteristics were compared using McNemar's test with Bonferroni correction (two-sided
level of significance < o.o5). Diagnostic power of thoracocentesis, chest x-ray, CT-scanning,
PET-CT scanning and the combination are calculated. Diagnostic power is defined as true
positive, true negative, false positive, false negative, sensitivity, specificity, likelihood
ratio+, likelihood ratio-, positive predictive value (PPV), negative predictive value (NPV)
and diagnostic accuracy (TP+TN)/(TP+FP+TN+FN).
The combined sensitivity will be calculated using the formula:
Sensitivitytest A + Sensitivitytest B + Sensitivitytest … - (Sensitivitytest A x
Sensitivitytest B x Sensitivitytest …)
The combined specificity will be calculated using the formula:
Specificitytest A x Specificitytest B x Specificitytest… Data were analyzed using STATA
(StataCorp LLC, Version 15.0, College Station, Texas, USA).
