Actively Recruiting
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
Led by Imperial College London · Updated on 2024-11-04
200
Participants Needed
23
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
This research aims to improve the accuracy of MRI scans in detecting early-stage rectal cancer and significant rectal polyps. Many patients with early rectal cancer currently undergo major surgery or unnecessary treatments due to inaccurate staging. The study evaluates a new MRI reading method called PRESERVE, which has been shown to identify early rectal cancers more accurately and may allow more patients to have less invasive local excision surgery that preserves the rectum and quality of life. The study compares two phases a control phase where patients receive standard care, and an intervention phase following training of radiologists in the PRESERVE MRI staging method. During the intervention phase, MRI scans are recommended for rectal polyps 20mm or larger or with suspicious features before removal, alongside radiologist training. Each hospital transitions from control to intervention at a randomized time, with no crossover of patients between phases. Participants will be monitored through clinical investigations before, during, and after treatment as per standard care. Researchers will assess the accuracy of tumor staging on MRI, the number of patients identified for rectal preservation surgery, and quality of life outcomes over up to 5 years. Additional measures include scan quality, tumor characteristics, treatment costs, and histopathological biomarkers. The primary outcome is the impact of radiologist training on staging accuracy measured after one year.
CONDITIONS
Brief Title
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have a rectal tumor or suspected tumor that is T3b or less on MRI or pT2 or less after excision, or a tumor 20mm or larger on endoscopy with suspicion of malignancy
- Be aged 16 years or older
You will not qualify if you...
- Have metastatic disease at the time of initial staging
- Have a biopsy-proven rectal malignancy that is not adenocarcinoma
- Are contraindicated for MRI scans
Research Team
C
Caroline Martin
S
Syvella Ellis
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