Actively Recruiting

Phase Not Applicable
Age: 16Years +
All Genders
ID02222844

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Led by Imperial College London · Updated on 2024-10-17

244

Participants Needed

16

Research Sites

260 weeks

Total Duration

On this page

Sponsors

I

Imperial College London

Lead Sponsor

P

Pelican Cancer Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether using MRI imaging for staging sigmoid colon adenocarcinoma can change treatment plans by detecting more high-risk tumors compared to standard CT imaging. This randomized phase II multicenter trial aims to improve radical treatment decisions and provide better prognostic information to patients. The study involves patients eligible for curative treatment whose MRI can be reviewed before surgery without a prior treatment decision. Participants are assigned randomly to one of three groups: standard preoperative CT imaging with multidisciplinary team discussion, standard CT plus an additional preoperative MRI scan with team discussion, or observation only. The MRI provides supplementary diagnostic information that may alter treatment strategies based on local protocols. During the study, patients are followed up at 1 and 3 years with quality of life questionnaires. Researchers assess differences in cancer staging between CT and MRI, treatment changes, recurrence rates, disease-free survival, surgery quality, pathology outcomes, morbidity and mortality, and permanent stoma rates. The total follow-up extends up to 5 years after treatment, with outcomes measured at multiple time points to understand the impact of MRI staging on patient care.

CONDITIONS

Brief Title

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

Who Can Participate

Age: 16Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have a suspected or proven sigmoid colon adenocarcinoma
  • Eligible for curative treatment
  • No irresectable metastatic disease
  • MRI can be reviewed by a multidisciplinary team before surgery
  • No decision made regarding radical treatment
  • Provided written informed consent to participate
  • Aged 16 years or older
Not Eligible

You will not qualify if you...

  • Have metastatic disease, including resectable liver metastases
  • Have a synchronous second malignancy
  • Are contraindicated for MRI
  • Are contraindicated for or allergic to Buscopan (e.g., glaucoma, bowel obstruction, kidney function below threshold)
  • Have severe co-morbidities or medical history preventing chemo or radiotherapy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 4 weeks before surgery

Participants receive standard CT imaging and additional MRI scans to assess the staging of sigmoid colon cancer before treatment decisions.

1 to 2 imaging visits depending on assigned group

Treatment

Duration - Varies by individual treatment plan

Participants undergo curative treatment planned based on imaging results from CT or MRI assessments.

Visits occur according to local treatment protocols

Long-term Monitoring

Duration - Up to 5 years after treatment

Participants are monitored for recurrence, survival, and quality of life outcomes following treatment.

Periodic follow-up visits over several years

Trial Site Locations

Total: 16 locations

1

Hinchingbrooke Hospital

Huntingdon, Cambridgeshire, United Kingdom, PE29 6NT

Actively Recruiting

2

Leighton Hospital

Crewe, Cheshire, United Kingdom, CW1 4QJ

Actively Recruiting

3

University Hospital of North Tees

Stockton-on-Tees, County Durham, United Kingdom, TS19 8PE

Actively Recruiting

4

Croydon University Hospital

Thornton Heath, Croydon, United Kingdom, CR7 7YE

Actively Recruiting

5

Chesterfield Royal

Chesterfield, Derbyshire, United Kingdom, SS4 5BL

Actively Recruiting

6

Queen Alexandra Hospital

Portsmouth, Hampshire, United Kingdom, PO6 3LY

Actively Recruiting

7

St Mark's Hospital

Middlesex, Harrow, United Kingdom, HA1 3UJ

Actively Recruiting

8

Maidstone Hospital

Maidstone, Kent, United Kingdom, ME16 9QQ

Actively Recruiting

9

Queen Elizabeth the Queen Mother Hospital

Margate, Kent, United Kingdom, CT9 4AN

Actively Recruiting

10

North Manchester General Hospital

Crumpsall, Manchester, United Kingdom, M8 5RB

Actively Recruiting

11

University Hospital of South Manchester & Manchester Royal Infirmary

Wythenshawe, Manchester, United Kingdom, M23 9LT

Actively Recruiting

12

Harrogate District Hospital

Harrogate, North Yorkshire, United Kingdom, HG2 7SX

Actively Recruiting

13

Musgrove Park Hospital

Taunton, Somerset, United Kingdom, TA1 5DA

Actively Recruiting

14

Yeovil District Hospital

Yeovil, Somerset, United Kingdom, BA21 4AT

Active, Not Recruiting

15

Royal Marsden Hospital

Sutton, Surrey, United Kingdom, SM2 5PT

Actively Recruiting

16

Salisbury District Hospital

Salisbury, Whiltshire, United Kingdom, SP2 8BJ

Actively Recruiting

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Research Team

C

Caroline Martin

S

Syvella Ellis

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

3

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