Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
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
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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