Title: Comprehensive staging of newly diagnosed lung and colorectal cancer: Prospective multicentre comparison of whole body Magnetic Resonance Imaging with standard diagnostic imaging pathways
Funder: Department of Health and Social Care

Abstract: BACKGROUND: Whole body MRI (WB-MRI) is advocated as alternative to the current multi-modality staging pathways in lung and colorectal cancer. PLAN OF INVESTIGATION: Lung and colorectal cancers will be studied in parallel but separate studies. WB-MRI will be undertaken in 5 central hubs and patients will be recruited from up to 15 hospital sites encompassing a range of teaching and district general hospital environments. Eligibility criteria: 1. Patients newly diagnosed with potentially radically treatable non small cell lung cancer. 2) Patients newly diagnosed with colorectal cancer (excluding early stage polyp cancers). Recruited patients will undergo WB-MRI in addition to standard tests and the result withheld until they have completed the standard diagnostic pathway to definitive staging and first major treatment decision (referral for surgery, chemo-and/or radio-therapy, or palliative care). The multi disciplinary team meeting will define the nature of the first treatment decision based on (i) standard investigations, and (ii) the WB-MRI result alone. The final treatment plan will be based on all available information. Patient outcomes and resource use will be followed for 12 months. A multi disciplinary consensus panel will meet annually to derive the standard reference for disease stage at diagnoses. Patient interviews, questionnaires and a discrete choice experiment will assess which aspects of the staging process are of greatest importance to patients and derive the comparative acceptability of WB-MRI to standard staging pathways SAMPLE SIZE: Lung: 250. Colorectal: 322 patients. HEALTH ECONOMIC ANALYSIS: Care pathways for both cancers lung will be divided into two stages, the initial treatment decision pathway and the subsequent disease treatment pathway. The incremental cost of WB-MRI versus standard investigations in the treatment decision pathway will be calculated from test use data. STATISTICAL ANALYSIS, OUTCOME MEASURES: All study outcomes will be calculated separately for each cancer.

Lay abstract: MRI (magnetic resonance imaging) is an imaging test used widely in the NHS, which produces images without using X-Rays. It is now possible to image the whole body in under an hour (WB-MRI). To plan the best treatment for patients diagnosed with cancer, it is important to stage the cancer i.e. establish whether it has spread to different parts of the body. Currently patients undergo several different imaging tests (e.g. CT and PET scans) which add to time and cost, and expose them to X-Rays. This study will assess whether WB-MRI is accurate enough to reduce the number of these tests, or indeed replace them so patients can be staged more quickly, possibly at lesser cost. Patients with newly diagnosed lung or colorectal cancer will undergo WB-MRI in addition to standard staging investigations. The WB-MRI results will be withheld until patients have completed their standard staging pathways and first major treatment decision documented before being released to doctors who will note what treatment would have been made if just WB-MRI had been available, and make their final treatment plan based on everything. Patients will be followed for 12 months during which time their use of health care resources will be collated. An expert consensus panel will derive the reference standard for the cancer stage at diagnosis. Via interviews and questionnaires the study will assess which parts of the imaging tests patients do and don’t like and which aspects of the whole staging cancer staging process they consider most important. The main outcome is the comparative ability of WB-MRI and standard staging to detect patients with metastasis (disease spread) at diagnosis. In total 250 and 322 lung and colon cancer patients will be recruited respectively. Other outcomes include comparative time to staging, test number, economic evaluation and assessment of patient experience

Research activity codes: 4.2 EVALUATION OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS