An interventional study of Contrast-enhanced CT and PET-CT in Lung Neoplasms, sponsored by Simon Reuter. Terminated at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-17.
Sponsored by Simon Reuter · Not applicable, Interventional, and Diagnostic
Recurrent unilateral, non-infectious pleural exudate is suspicious for primary or secondary pleural malignancy. Both conditions are associated with 5-year survival of 10%. Work-up is difficult, as the pleural surface is large and \<33% of pleural malignancies shed malignant cells to the pleural fluid. Even so, additional tissue biopsies are needed for establishing mutation status for targeted therapies.
Optimal imaging to guide tissue sampling is pivotal. PET-CT has higher sensitivity than conventional CT for detecting malignant lesions >10mm. However, no randomised trial has investigated differences in diagnostic accuracy, time-to-diagnosis, or economics. Falsely PET-positive lesions in e.g. colon however, lead to more derived tests than do CT alone.
Gold standard for pleural tissue sampling is the surgical (VATS) thoracoscopy, allowing direct visual guiding of tissue sampling from all pleural surfaces. Yet, globally the medical (pleuroscopy) thoracoscopy is more widely used: cheaper, outpatient procedure, but allows only sampling from the parietal pleura. To date, no randomised studies have compared medical and surgical thoracoscopy concerning diagnostic hit rates, adverse events, or economics.
The investigators will perform two randomized studies to investigate whether
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 5,295 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →This is the only study on the registry with Simon Reuter as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Contrast-enhanced CT scan of the thorax and abdomen.
Device: Contrast-enhanced CT
Positron-emission-CT scanning (low dose without contrast) of the thorax and abdomen.
Device: PET-CT
50% of patients with unilateral pleural effusion will have performed a CE-CT
50% of patients with unilateral pleural effusion will have performed a PET-CT
Number of diagnostic thoracoscopies (either MT or VATS)
Time frame: 2 years
Number of derived investigations (i.e. gastroscopy, coloscopy)
Time frame: 2 years
Number of patients diagnosed with cancer (cancer = an unequivocal diagnosis of neoplastic disease; no cancer = clinically benign cause, and improved imaging at 6 month control)
Time frame: 2 years
Patient satisfaction and patient perceived discomfort
Using QLQC 30
Time frame: 2 years
Total costs calculated as costs patient-related, procedure-related, and overall
Time frame: 2 years
Total procedures before cancer-diagnosis (cancer = yes/no)
Time frame: 2 years
Patient satisfaction and patient perceived discomfort
EuroQol Q-5D a standardised instrument for use as a measure of health outcome
Time frame: 2 years
This study is terminated, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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