Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers (NCT02222844) | Clinical Trial Compass
RecruitingNot Applicable
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
United Kingdom244 participantsStarted 2014-08
Plain-language summary
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.
Who can participate
Age range16 Years
SexALL
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Inclusion criteria
✓. Have a suspected or proven sigmoid colon adenocarcinoma
✓. Is eligible for curative treatment
✓. Has no irresectable metastatic disease
✓. MRI can be reviewed by an MDT prior to surgery
✓. Has no decision regarding radical treatment
✓. Have provided written informed consent to participate in the study
✓. Be aged 16 years or over
Exclusion criteria
✕. Have metastatic disease (including resectable liver metastases)
✕. Have a synchronous second malignancy
✕. Are contraindicated for MRI
✕. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR\<30)
What they're measuring
1
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Timeframe: 3 years after last recruit
2
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.