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

Imperial College London

Status: Enrolling

Conditions: Colon, Sigmoid; General Surgery; Colorectal Neoplasms; Cancer; Magnetic Resonance Imaging

Treatments: Other: Preoperative MRI scan

Study type: Interventional

Funder types: Other

Identifiers

NCT02222844

DOCUMAS: 23HH8201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 244 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

244 participants in 3 patient groups

Preoperative CT scan

No Intervention group

Description:

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

Preoperative MRI scan

Experimental group

Description:

Standard treatment plus an additional MRI scan before surgery

Treatment:

Other: Preoperative MRI scan

Observational

No Intervention group

Description:

Observational only