Colorectal cancer Cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult patients (18 or over) with histologically proven or suspected colorectal cancer referred for staging. 2. Suspicion of colorectal cancer defined as: Presence of a mass highly suspicious for colorectal cancer on endoscopy, barium enema, CT colonography or other imaging which triggers staging investigations. 3. 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 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. Polyp cancer (because metastatic disease in these patients is vanishingly rare)
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 colorectal 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