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Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Recruiting
16 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging

NCT02222844

Imperial College London

26 January 2024

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