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

Primary Purpose

Cancer, Colorectal Neoplasms, Colon, Sigmoid

Status
Recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Preoperative MRI scan
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Cancer focused on measuring Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All patients with pelvic sigmoid colon (demonstrated on colonoscopy and biopsy) who are eligible for curative treatment (for the purposes of the IMPRESS study, the sigmoid tumour must be over 15cm from the anal verge)

Exclusion Criteria:

Less than 18 years old

  • Unable to consent
  • Consent witheld or withdrawn
  • Unable to have an MRI (e.g. pacemaker, metal implant in major viscera, severe claustrophobia)
  • Allergy or contraindication to Buscopan, small bowel contrast agent or gadolinium (e.g. glaucoma, small or large bowel obstruction, GFR <30)
  • A previous history of colorectal cancer
  • Presence of irresectable distant metastases
  • Severe co-morbidities that prevent the application of eventual chemo/radiotherapy

Sites / Locations

  • Hinchingbrooke HospitalRecruiting
  • Leighton HospitalRecruiting
  • University Hospital of North TeesRecruiting
  • Croydon University HospitalRecruiting
  • Chesterfield RoyalRecruiting
  • Queen Alexandra HospitalRecruiting
  • St Mark's HospitalRecruiting
  • Maidstone HospitalRecruiting
  • Queen Elizabeth the Queen Mother HospitalRecruiting
  • North Manchester General HospitalRecruiting
  • University Hospital of South Manchester & Manchester Royal InfirmaryRecruiting
  • Harrogate District HospitalRecruiting
  • Musgrove Park HospitalRecruiting
  • Yeovil District Hospital
  • Royal Marsden HospitalRecruiting
  • Salisbury District HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

No Intervention

Arm Label

Preoperative CT scan

Preoperative MRI scan

Observational

Arm Description

CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)

Standard treatment plus an additional MRI scan before surgery

Observational only

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI

Full Information

First Posted
August 20, 2014
Last Updated
August 29, 2023
Sponsor
Imperial College London
Collaborators
Pelican Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02222844
Brief Title
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
Acronym
IMPRESS
Official Title
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 2014 (undefined)
Primary Completion Date
December 2027 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London
Collaborators
Pelican Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery
Keywords
Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
244 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Preoperative CT scan
Arm Type
No Intervention
Arm Description
CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)
Arm Title
Preoperative MRI scan
Arm Type
Experimental
Arm Description
Standard treatment plus an additional MRI scan before surgery
Arm Title
Observational
Arm Type
No Intervention
Arm Description
Observational only
Intervention Type
Other
Intervention Name(s)
Preoperative MRI scan
Intervention Description
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Primary Outcome Measure Information:
Title
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Description
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
Title
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
Description
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
Secondary Outcome Measure Information:
Title
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Description
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
Time Frame
3 years after last recruit
Title
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Description
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
Time Frame
1 and 3 years after last recruit
Title
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Description
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
Time Frame
5 years
Title
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
Description
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
Time Frame
3 years after last recruit
Title
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Description
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
Title
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Description
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
Time Frame
3 years after last recruit
Title
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Description
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
Time Frame
1 and 3 years after last recruit
Title
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Description
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
Time Frame
3 years after last recruit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Martin
Phone
+44 (0) 7749 655 817
Email
c.martin1@imperial.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Syvella Ellis
Phone
+44 (0) 7732 315 234
Email
giclinicaltrials@imperial.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Brown
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hinchingbrooke Hospital
City
Huntingdon
State/Province
Cambridgeshire
ZIP/Postal Code
PE29 6NT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Mitchell
Email
davidmitchell4@nhs.net
First Name & Middle Initial & Last Name & Degree
Susan Donnelly
Email
susan.donnelly1@nhs.net
First Name & Middle Initial & Last Name & Degree
David Mitchell
Facility Name
Leighton Hospital
City
Crewe
State/Province
Cheshire
ZIP/Postal Code
CW1 4QJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chris Hough
Email
Chris.Hough@mcht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Vanessa Adamson
Email
Vanessa.Adamson@mcht.nhs.uk
First Name & Middle Initial & Last Name & Degree
Michael Braun
Facility Name
University Hospital of North Tees
City
Stockton-on-Tees
State/Province
County Durham
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Helen Wilson
Email
Helen.Wilson2@nth.nhs.uk
First Name & Middle Initial & Last Name & Degree
Anil Agarwal
Facility Name
Croydon University Hospital
City
Thornton Heath
State/Province
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Muti Abulafi
Email
muti.abulafi@nhs.net
First Name & Middle Initial & Last Name & Degree
Ibiyemi Sadare
Email
ibiyemi.sadare@nhs.net
First Name & Middle Initial & Last Name & Degree
Muti Abulafi
Facility Name
Chesterfield Royal
City
Chesterfield
State/Province
Derbyshire
ZIP/Postal Code
SS4 5BL
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lesley Stevenson
Email
lesley.stevenson@nhs.net
First Name & Middle Initial & Last Name & Degree
Harjeet Singh Narula
Facility Name
Queen Alexandra Hospital
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Higginson
Email
antony.higginson@porthosp.nhs.uk
First Name & Middle Initial & Last Name & Degree
Nicola Gibbons
Email
nicola.gibbons@porthosp.nhs.uk
First Name & Middle Initial & Last Name & Degree
Anthony Higginson
Facility Name
St Mark's Hospital
City
Middlesex
State/Province
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anthony Antoniou
Email
a.antoniou1@nhs.net
First Name & Middle Initial & Last Name & Degree
Pooja Datt
Email
pooja.datt@nhs.net
First Name & Middle Initial & Last Name & Degree
Anthony Antoniou
Facility Name
Maidstone Hospital
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paulette Basham
Email
paulette.basham@nhs.net
First Name & Middle Initial & Last Name & Degree
Sukanya Ghosh
Facility Name
Queen Elizabeth the Queen Mother Hospital
City
Margate
State/Province
Kent
ZIP/Postal Code
CT9 4AN
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Turney
Email
sharon.turney@nhs.net
First Name & Middle Initial & Last Name & Degree
Jess Evans
Facility Name
North Manchester General Hospital
City
Crumpsall
State/Province
Manchester
ZIP/Postal Code
M8 5RB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Salim Kurrimboccus
Email
Salim.Kurrimboccus@pat.nhs.uk
First Name & Middle Initial & Last Name & Degree
Joanne Allsop
Email
Joanne.Allsop@pat.nhs.uk
First Name & Middle Initial & Last Name & Degree
Salim Kurrimbossus
Facility Name
University Hospital of South Manchester & Manchester Royal Infirmary
City
Wythenshawe
State/Province
Manchester
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Duff
Email
Sarah.Duff@UHSM.NHS.UK
First Name & Middle Initial & Last Name & Degree
Lindsay Piper
Email
Lindsay.Piper@UHSM.NHS.UK
First Name & Middle Initial & Last Name & Degree
Sarah Duff
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
North Yorkshire
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Leinhardt
First Name & Middle Initial & Last Name & Degree
Lisa Jones
Email
Lisa.Jones@hdft.nhs.uk
First Name & Middle Initial & Last Name & Degree
David Leinhardt
Facility Name
Musgrove Park Hospital
City
Taunton
State/Province
Somerset
ZIP/Postal Code
TA1 5DA
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jan Ashcroft
Email
Jan.ashcroft@tst.nhs.uk
First Name & Middle Initial & Last Name & Degree
Erica Beaumont
Facility Name
Yeovil District Hospital
City
Yeovil
State/Province
Somerset
ZIP/Postal Code
BA21 4AT
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Royal Marsden Hospital
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cordelia Grant
Email
cordelia.grant@rmh.nhs.uk
First Name & Middle Initial & Last Name & Degree
Irene Chong, MD
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
Whiltshire
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Graham Branagan
Email
Graham.Branagan@salisbury.nhs.uk
First Name & Middle Initial & Last Name & Degree
Ruth Casey
Email
Ruth.Casey@salisbury.nhs.uk
First Name & Middle Initial & Last Name & Degree
Graham Branagan

12. IPD Sharing Statement

Learn more about this trial

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

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