Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers (IMPRESS)

August 29, 2023 updated by: Imperial College London
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

244

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
    • Cambridgeshire
      • Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT
    • Cheshire
    • County Durham
      • Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE
        • Recruiting
        • University Hospital of North Tees
        • Contact:
        • Principal Investigator:
          • Anil Agarwal
    • Croydon
      • Thornton Heath, Croydon, United Kingdom, CR7 7YE
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, SS4 5BL
        • Recruiting
        • Chesterfield Royal
        • Contact:
        • Principal Investigator:
          • Harjeet Singh Narula
    • Hampshire
    • Harrow
      • Middlesex, Harrow, United Kingdom, HA1 3UJ
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Recruiting
        • Maidstone Hospital
        • Contact:
        • Principal Investigator:
          • Sukanya Ghosh
      • Margate, Kent, United Kingdom, CT9 4AN
        • Recruiting
        • Queen Elizabeth the Queen Mother Hospital
        • Contact:
        • Principal Investigator:
          • Jess Evans
    • Manchester
      • Crumpsall, Manchester, United Kingdom, M8 5RB
      • Wythenshawe, Manchester, United Kingdom, M23 9LT
    • North Yorkshire
      • Harrogate, North Yorkshire, United Kingdom, HG2 7SX
        • Recruiting
        • Harrogate District Hospital
        • Contact:
          • David Leinhardt
        • Contact:
        • Principal Investigator:
          • David Leinhardt
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital
        • Contact:
        • Principal Investigator:
          • Erica Beaumont
      • Yeovil, Somerset, United Kingdom, BA21 4AT
        • Active, not recruiting
        • Yeovil District Hospital
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
        • Principal Investigator:
          • Irene Chong, MD
    • Whiltshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Have a suspected or proven sigmoid colon adenocarcinoma
  2. Is eligible for curative treatment
  3. Has no irresectable metastatic disease
  4. MRI can be reviewed by an MDT prior to surgery
  5. Has no decision regarding radical treatment
  6. Have provided written informed consent to participate in the study
  7. Be aged 16 years or over

Exclusion Criteria:

  1. Have metastatic disease (including resectable liver metastases)
  2. Have a synchronous second malignancy
  3. Are contraindicated for MRI
  4. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
  5. Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Preoperative CT scan
CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)
Experimental: Preoperative MRI scan
Standard treatment plus an additional MRI scan before surgery
Other: Preoperative MRI scan
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
No Intervention: Observational
Observational only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
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
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
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
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
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
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
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
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
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
Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes
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
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
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
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
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
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
3 years after last recruit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London

Collaborators

Pelican Cancer Foundation

Investigators

  • Principal Investigator: Gina Brown, Imperial College London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2014

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 20, 2014

First Submitted That Met QC Criteria

August 20, 2014

First Posted (Estimated)

August 21, 2014

Study Record Updates

Last Update Posted (Actual)

September 1, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DOCUMAS: 23HH8201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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