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NCT Number: NCT02222844

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

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.

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hinchingbrooke Hospital, Huntingdon, Cambridgeshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Preoperative MRI scan

Other

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

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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)

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Syvella Ellis

CONTACT

[email protected]

+44 (0) 7732 315 234

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Pelican Cancer Foundation

Registry information

Acronym: IMPRESS

Important dates

Study start
2014
Primary completion
2026
Study completion
2031
First posted
Aug 21, 2014
Registry last updated
Oct 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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