Preoperative MRI scan
OtherStandard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
NCT Number: NCT02222844
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.
Interested in participating?
Request Info16 year and older
All sexes
Interventional
Not applicable
Hinchingbrooke Hospital, Huntingdon, Cambridgeshire, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Time frame: 3 years after last recruit
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
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
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
Time frame: 1 and 3 years after last recruit
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
Time frame: 5 years
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
Time frame: 3 years after last recruit
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
Time frame: 3 years after last recruit
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
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
Time frame: 1 and 3 years after last recruit
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
Time frame: 3 years after last recruit
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
Contact information is provided by the study sponsor or research team.
Caroline Martin
CONTACT
Syvella Ellis
CONTACT
Imperial College London
Other
Acronym: IMPRESS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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