An interventional study of Preoperative MRI scan in Cancer, Colorectal Neoplasms and Colon, Sigmoid, sponsored by Imperial College London. Recruiting at 16 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.
A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
Exclusion Criteria:
CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)
Standard treatment plus an additional MRI scan before surgery
Other: Preoperative MRI scan
Observational only
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings
Time frame: 3 years after last recruit
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI
Time frame: 3 years after last recruit
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
Time frame: 3 years after last recruit
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
Time frame: 1 and 3 years after last recruit
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
Time frame: 5 years
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
Time frame: 3 years after last recruit
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes
Time frame: 3 years after last recruit
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
Time frame: 3 years after last recruit
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
Time frame: 1 and 3 years after last recruit
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
Time frame: 3 years after last recruit
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Imperial College London