Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

NCT ID: NCT02222844

Last Updated: 2024-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

244 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-08-31

Study Completion Date

2031-12-31

Brief Summary

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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

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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.

Conditions

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Cancer Colorectal Neoplasms Colon, Sigmoid Magnetic Resonance Imaging General Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Preoperative CT scan

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Preoperative MRI scan

Standard treatment plus an additional MRI scan before surgery

Group Type EXPERIMENTAL

Preoperative MRI scan

Intervention Type OTHER

Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

Observational

Observational only

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Preoperative MRI scan

Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pelican Cancer Foundation

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gina Brown

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

Locations

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Hinchingbrooke Hospital

Huntingdon, Cambridgeshire, United Kingdom

Site Status RECRUITING

Leighton Hospital

Crewe, Cheshire, United Kingdom

Site Status RECRUITING

University Hospital of North Tees

Stockton-on-Tees, County Durham, United Kingdom

Site Status RECRUITING

Croydon University Hospital

Thornton Heath, Croydon, United Kingdom

Site Status RECRUITING

Chesterfield Royal

Chesterfield, Derbyshire, United Kingdom

Site Status RECRUITING

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom

Site Status RECRUITING

St Mark's Hospital

Middlesex, Harrow, United Kingdom

Site Status RECRUITING

Maidstone Hospital

Maidstone, Kent, United Kingdom

Site Status RECRUITING

Queen Elizabeth the Queen Mother Hospital

Margate, Kent, United Kingdom

Site Status RECRUITING

North Manchester General Hospital

Crumpsall, Manchester, United Kingdom

Site Status RECRUITING

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe, Manchester, United Kingdom

Site Status RECRUITING

Harrogate District Hospital

Harrogate, North Yorkshire, United Kingdom

Site Status RECRUITING

Musgrove Park Hospital

Taunton, Somerset, United Kingdom

Site Status RECRUITING

Yeovil District Hospital

Yeovil, Somerset, United Kingdom

Site Status ACTIVE_NOT_RECRUITING

Royal Marsden Hospital

Sutton, Surrey, United Kingdom

Site Status RECRUITING

Salisbury District Hospital

Salisbury, Whiltshire, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Caroline Martin

Role: CONTACT

+44 (0) 7749 655 817

Syvella Ellis

Role: CONTACT

+44 (0) 7732 315 234

Facility Contacts

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David Mitchell

Role: primary

Susan Donnelly

Role: backup

Chris Hough

Role: primary

Vanessa Adamson

Role: backup

Helen Wilson

Role: primary

Muti Abulafi

Role: primary

Ibiyemi Sadare

Role: backup

Lesley Stevenson

Role: primary

Anthony Higginson

Role: primary

Nicola Gibbons

Role: backup

Anthony Antoniou

Role: primary

Pooja Datt

Role: backup

Paulette Basham

Role: primary

Sharon Turney

Role: primary

Salim Kurrimboccus

Role: primary

Joanne Allsop

Role: backup

Sarah Duff

Role: primary

Lindsay Piper

Role: backup

David Leinhardt

Role: primary

Lisa Jones

Role: backup

Jan Ashcroft

Role: primary

Cordelia Grant

Role: primary

Graham Branagan

Role: primary

Ruth Casey

Role: backup

Other Identifiers

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DOCUMAS: 23HH8201

Identifier Type: -

Identifier Source: org_study_id

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