Non small cell lung cancer Cancer Malignant neoplasm of bronchus and lung
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 or over) with histologically proven or clinically diagnosed primary non small cell lung cancer with potentially radically treatable disease 2. Clinically diagnosed non small cell lung cancer defined as radiological diagnosis of lung cancer on chest CT with sufficient confidence to trigger staging investigations 3. Potentially radically treatable disease defined as stage IIIb or less on diagnostic CT (ie T14, N02, M0) 4. Performance status 02 (fit to undergo surgery if indicated) 5. Patient must have given written informed consent and be willing to comply with the protocol intervention and follow up.
Exclusion criteria
Exclusion criteria: 1. Any psychiatric or other disorder likely to impact on informed consent 2. Evidence of severe or uncontrolled systemic disease which make it undesirable the for the patient to participate in the trial 3. Pregnancy 4. Contraindications to MRI (e.g. cardiac pacemaker, severe claustrophobia, inability to lie flat) 5. Unequivocal metastatic or N3 disease on diagnostic CT chest and abdomen (including M1a disease; malignant pleural effusion) 6. Further staging work up not indicated in the opinion of the MDT due to poor performance status or patient choice. 7. Histologies other than non small cell lung cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Per patient sensitivity for metastasis detection by whole body MRI (WB-MRI) compared to standard staging pathways in newly diagnosed non small cell lung cancer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The time and test number taken to reach, and the nature of, the first major treatment decision based on WB-MRI in comparison to standard staging pathways. 2. Diagnostic accuracy of WB-MRI and conventional staging pathways for local tumour staging and detection of metastasis in comparison to an expert derived consensus reference standard. 3. Lifetime incremental cost and cost-effectiveness of staging using WB-MRI compared to standard diagnostic pathways. 4. Patient experience of staging using WB-MRI in comparison to standard diagnostic pathways and priorities placed by patients on differing attributes related to competing staging pathways. 5. Inter-observer variability in WB-MRI analysis and affect of diagnostic confidence on staging accuracy. 6. Diagnostic accuracy of limited T1 and diffusion weighted sequences compared to full multi-sequence WB-MRI protocols. | — |
Countries
United Kingdom