MRI cT1-2 rectal cancer staging accuracy: a population-based study.
R Detering, S E van Oostendorp, V M Meyer...
https://pubmed.ncbi.nlm.nih.gov/32297326/Actively Recruiting
Led by Imperial College London · Updated on 2024-11-04
200
Participants Needed
23
Research Sites
260 weeks
Total Duration
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
Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
C
Caroline Martin
S
Syvella Ellis
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Imperial College London
Lead Sponsor
Pelican Cancer Foundation
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year
Participants undergo MRI scans to assess rectal polyps or tumors prior to removal to improve staging accuracy and reduce unnecessary major surgery.
MRI scans as recommended before removal procedures
Duration - 1 month transition period for training implementation
Radiologists receive training on the PRESERVE MRI staging system to improve diagnosis accuracy for early rectal cancer.
Training sessions for radiologists (participant visit info not applicable)
Duration - Up to 5 years
Participants are monitored for outcomes related to treatment decisions and quality of life following MRI assessment and any subsequent surgeries.
Follow-up visits and questionnaires at 1, 3, and 5 years post-treatment
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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R Detering, S E van Oostendorp, V M Meyer...
https://pubmed.ncbi.nlm.nih.gov/32297326/Svetlana Balyasnikova, James Read, Andrew Wotherspoon...
https://pubmed.ncbi.nlm.nih.gov/29259791/Imperial College London
Lead Sponsor
Pelican Cancer Foundation
Collaborating Sponsor