Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Preoperative MRI scan.
- Who it may be relevant to
- Registry conditions: Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging. Basic parameters: from 16 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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.
Interventions
- Other Preoperative MRI scan
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Primary outcome measures
- Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI. [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. [Time frame: 3 years after last recruit]
Secondary outcome measures (8)
- To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk. [Time frame: 3 years after last recruit]
- To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk. [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. [Time frame: 5 years]
- To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk [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. [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. [Time frame: 3 years after last recruit]
- To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk. [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. [Time frame: 3 years after last recruit]
Eligibility criteria
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)
- Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United Kingdom · 16 centers
- Hinchingbrooke Hospital — Huntingdon
- Leighton Hospital — Crewe
- University Hospital of North Tees — Stockton-on-Tees
- Croydon University Hospital — Thornton Heath
- Chesterfield Royal — Chesterfield
- Queen Alexandra Hospital — Portsmouth
- St Mark's Hospital — Middlesex
- Maidstone Hospital — Maidstone
- … and 8 more centers
Identifiers
NCT: NCT02222844 · DOCUMAS: 23HH8201