Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
IMPRESS
1 other identifier
interventional
244
1 country
16
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable cancer
Started Aug 2014
Longer than P75 for not_applicable cancer
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
August 20, 2014
CompletedFirst Posted
Study publicly available on registry
August 21, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
October 17, 2024
October 1, 2024
12.3 years
August 20, 2014
October 16, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
3 years after last recruit
Secondary Outcomes (8)
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
3 years after last recruit
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
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.
5 years
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
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.
3 years after last recruit
- +3 more secondary outcomes
Study Arms (3)
Preoperative CT scan
NO INTERVENTIONCT-imaging of chest and abdomen / pelvis before surgery (standard treatment)
Preoperative MRI scan
EXPERIMENTALStandard treatment plus an additional MRI scan before surgery
Observational
NO INTERVENTIONObservational only
Interventions
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
- Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Imperial College Londonlead
- Pelican Cancer Foundationcollaborator
Study Sites (16)
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT, United Kingdom
Leighton Hospital
Crewe, Cheshire, CW1 4QJ, United Kingdom
University Hospital of North Tees
Stockton-on-Tees, County Durham, TS19 8PE, United Kingdom
Croydon University Hospital
Thornton Heath, Croydon, CR7 7YE, United Kingdom
Chesterfield Royal
Chesterfield, Derbyshire, SS4 5BL, United Kingdom
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY, United Kingdom
St Mark's Hospital
Middlesex, Harrow, HA1 3UJ, United Kingdom
Maidstone Hospital
Maidstone, Kent, ME16 9QQ, United Kingdom
Queen Elizabeth the Queen Mother Hospital
Margate, Kent, CT9 4AN, United Kingdom
North Manchester General Hospital
Crumpsall, Manchester, M8 5RB, United Kingdom
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, M23 9LT, United Kingdom
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Yeovil District Hospital
Yeovil, Somerset, BA21 4AT, United Kingdom
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT, United Kingdom
Salisbury District Hospital
Salisbury, Whiltshire, SP2 8BJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gina Brown
Imperial College London
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2014
First Posted
August 21, 2014
Study Start
August 1, 2014
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2031
Last Updated
October 17, 2024
Record last verified: 2024-10