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Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Sponsor: Imperial College London

NCT ID: NCT02222844

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Preoperative MRI scan (other)
How long the study runs
Study runs about 208 months (dates as stated)
About the drug or intervention
Preoperative MRI scan — other: Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
Patient visit burden
Not specified by the sponsor

In plain English

This study, run by Imperial College London, looks at whether MRI (magnetic resonance imaging, a scan that uses magnets instead of X-rays) scans can help improve treatment for people with cancer of the sigmoid colon (the lower part of the large bowel). The aim is for the scan to be reviewed by a team of doctors before surgery so decisions about treatment can be better planned. Further detail on the study's methods is not stated — ask the trial team.

Who can take part

  • You have a suspected or confirmed cancer of the sigmoid colon (an adenocarcinoma)
  • You are able to have treatment that aims to cure the cancer
  • Your cancer has not spread in a way that cannot be removed by surgery
  • Your MRI scan can be reviewed by a team of specialists (an MDT, or multidisciplinary team) before surgery
  • No decision has yet been made about your major (radical) treatment
  • You have given written informed consent to take part
  • You are aged 16 or over

Who may not be able to

  • Your cancer has spread to other parts of the body (including spread to the liver that could be removed)
  • You have a second cancer at the same time
  • You cannot have an MRI scan (for example, for medical reasons)
  • You cannot have, or are allergic to, Buscopan (a medicine used during the scan) — for example because of glaucoma, a blocked bowel, or very poor kidney function
  • You have serious other health problems or a medical history that would prevent chemotherapy or radiotherapy if needed

What taking part involves

  • • Having an MRI scan that is reviewed by a specialist team before surgery
  • • Not stated — ask the trial team about any other tests or procedures involved

Time commitment: Not stated — ask the trial team about how many visits are needed, how long the study lasts, and exactly what taking part involves.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
16 Years and over
Who
All
Number of participants
244
Started
2014-08
Last checked
2024-10

Plain English Summary

What is this study?

  • • Testing a new treatment for cancer
  • • NA - 244 participants
  • • 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

Who can take part?

  • • Ages 16 Years and over
  • • Diagnosed with cancer

Where?

  • • Huntingdon - Hinchingbrooke Hospital
  • • Crewe - Leighton Hospital
  • • Stockton-on-Tees - University Hospital of North Tees
  • • Thornton Heath - Croydon University Hospital
  • • +12 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

More detail

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.

CancerColorectal NeoplasmsColon, SigmoidMagnetic Resonance ImagingGeneral Surgery

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 16 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Have a suspected or proven sigmoid colon adenocarcinoma
  • ✓Is eligible for curative treatment
  • ✓Has no irresectable that has spread disease
  • ✓MRI can be reviewed by an MDT prior to surgery
  • ✓Has no decision regarding radical treatment

Who cannot take part

  • ✗Have that has spread disease (including resectable liver metastases)
  • ✗Have a synchronous second cancer
  • ✗Are not safe to use for MRI
  • ✗Are not safe to use 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
See the full criteria
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

Where Is This Study? (16 UK sites)

Hinchingbrooke Hospital

Huntingdon PE29 6NT, United Kingdom

Recruiting
Site contact (verified)
David MitchellPrincipal Investigator

Leighton Hospital

Crewe CW1 4QJ, United Kingdom

Recruiting
Site contact (verified)
Michael BraunPrincipal Investigator

University Hospital of North Tees

Stockton-on-Tees TS19 8PE, United Kingdom

Recruiting
Site contact (verified)
Anil AgarwalPrincipal Investigator

Croydon University Hospital

Thornton Heath CR7 7YE, United Kingdom

Recruiting
Site contact (verified)
Muti AbulafiPrincipal Investigator

Chesterfield Royal

Chesterfield SS4 5BL, United Kingdom

Recruiting
Site contact (verified)
Harjeet Singh NarulaPrincipal Investigator
Lesley Stevensonlesley.stevenson@nhs.net

Queen Alexandra Hospital

Portsmouth PO6 3LY, United Kingdom

Recruiting
Site contact (verified)
Anthony HigginsonPrincipal Investigator

St Mark's Hospital

Middlesex HA1 3UJ, United Kingdom

Recruiting
Site contact (verified)
Anthony AntoniouPrincipal Investigator
Anthony Antonioua.antoniou1@nhs.net

Maidstone Hospital

Maidstone ME16 9QQ, United Kingdom

Recruiting
Site contact (verified)
Sukanya GhoshPrincipal Investigator

Queen Elizabeth the Queen Mother Hospital

Margate CT9 4AN, United Kingdom

Recruiting
Site contact (verified)
Jess EvansPrincipal Investigator

North Manchester General Hospital

Crumpsall M8 5RB, United Kingdom

Recruiting
Site contact (verified)
Salim KurrimbossusPrincipal Investigator

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe M23 9LT, United Kingdom

Recruiting
Site contact (verified)
Sarah DuffPrincipal Investigator

Harrogate District Hospital

Harrogate HG2 7SX, United Kingdom

Recruiting
Site contact (verified)
David LeinhardtPrincipal Investigator

Musgrove Park Hospital

Taunton TA1 5DA, United Kingdom

Recruiting
Site contact (verified)
Erica BeaumontPrincipal Investigator

Yeovil District Hospital

Yeovil BA21 4AT, United Kingdom

ACTIVE_NOT_RECRUITING
Hospital R&D contact (matched)

Karen Tanner

Research@somersetft.nhs.uk01935 384559

Royal Marsden Hospital

Sutton SM2 5PT, United Kingdom

Recruiting
Site contact (verified)
Irene Chong, MDPrincipal Investigator

Salisbury District Hospital

Salisbury SP2 8BJ, United Kingdom

Recruiting
Site contact (verified)
Graham BranaganPrincipal Investigator

How to Get in Touch

Caroline Martin

Sponsor contact

CONTACT

+44 (0) 7749 655 817 c.martin1@imperial.ac.uk

Syvella Ellis

Sponsor contact

CONTACT

+44 (0) 7732 315 234 giclinicaltrials@imperial.ac.uk
Data sourced from ClinicalTrials.gov · Last verified: 2024-10