About this trial
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. The investigators will provide consultant radiologists with the know-how to report MRI scans using this new method and compare this with the existing method. This study will test this by comparing how accurately the old versus new method predict the outcomes of patients. The existing method relies on radiologists determining if tumour has spread through the bowel wall or not and whether there are suspected malignant lymph nodes. The new method looks for tumour spread into the veins and whether or not there are tumour deposits. Our previous research has shown that the new method is much more accurate at predicting prognosis, but this finding needs to be verified by a larger multicentre study.
The investigators are also studying the patient journey, so the investigators can better understand patients' experiences and the impact that treatments have on their quality of life. The investigators wish to understand if improvements in the accuracy of prognosis from scans could change treatment decisions in future. The investigators will also compare the radiology scan prediction of prognostic factors by looking carefully at the tumour specimens.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Have a rectal cancer proven on biopsy or subsequent surgery
Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review
Aged 16 years or over
Disqualifiers
Have irresectable metastatic disease at time of initial staging
Undergoing palliative treatment for Rectal Cancer
Have a biopsy-proven rectal malignancy which is not adenocarcinoma
Are contraindicated for MRI staging
Trial design
Crossover
Treatments tested in this trial
mrTDV
Other interventionThe training of radiologists to implement specialised MRI reporting using the TDV staging system
Treatment groups
Trial outcomes
Primary outcomes
Validate that mrTDV staging can predict prognosis more accurately than mrTNM.
Survival differences for mrTNM and mrTDV before and after intervention will be compared
Secondary outcomes
Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer.
Compare percentage agreement between radiologists when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Compare percentage agreement when staging of tumours using mrTDV method of staging rectal cancer and TNM method of staging rectal cancer with respective histopathology staging for prognosis.
Compare agreement in prognostic accuracy between radiology and histopathology using when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions
Comparison of what and how many treatments are offered as MDT policy to patients before and after mrTDV intervention
Report changes in numbers of treatments offered following MRI-TDV staging intervention
Comparison of treatments given before and after mrTDV intervention
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: