Can extranodal tumour deposits be diagnosed on MRI? Protocol for a multicentre clinical trial (the COMET trial).
Amy C Lord, Brendan Moran, Muti Abulafi...
https://pubmed.ncbi.nlm.nih.gov/33033006Actively Recruiting
Led by Imperial College London · Updated on 2024-10-17
200
Participants Needed
1
Research Sites
260 weeks
Total Duration
I
Imperial College London
Lead Sponsor
P
Pelican Cancer Foundation
Collaborating Sponsor
Researchers are studying patients with suspected primary adenocarcinoma of the colon, sigmoid, or rectum who are scheduled for surgery. The goal is to see if using imaging mapping techniques before surgery can improve how well imaging and pathology agree in detecting tumour deposits. This study is a prospective, interventional, multi-center trial aiming to assess if additional radiological and pathological assessments can provide supplementary diagnostic information that might influence treatment and prognosis discussions. The study involves using MRI mapping to identify lymph nodes and tumour deposits on pre-operative scans. Radiologists will mark areas where extranodal disease is detected, and this map will be shared with pathologists before they process the surgical specimen. This approach guides the pathological sampling of tumour deposits in the mesorectum, which may lead to better pathological staging and impact treatment decisions. Patients will receive standard care and follow-up at their local hospitals. Participants will be followed for up to five years to monitor outcomes such as disease-free survival, overall survival, and time to local recurrence. Assessments include comparing imaging and pathology diagnoses of tumour deposits, evaluating features of the primary tumour and lymph nodes, and measuring agreement between local and central radiologists and pathologists. The primary outcome is to determine if imaging mapping increases detection of tumour deposits on pathology within two years. Safety monitoring and long-term follow-up are included as part of the study.
CONDITIONS
Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
You may qualify if you...
You will not qualify if you...
Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to the time of surgical resection and pathological assessment
Participants undergo MRI mapping to guide pathologists in sampling areas of the mesorectum where tumour deposits are likely to be present. This helps improve pathological staging and may influence treatment decisions.
Visits aligned with routine imaging and surgical care
Duration - Up to 5 years
Participants are monitored for up to 5 years to assess disease-free survival, overall survival, local recurrence, and the accuracy of imaging and pathological diagnosis of tumour deposits.
Follow-up visits scheduled according to local care protocols
Total: 1 location
1
Royal Marsden Hospital NHS Foundation Trust
London, Surrey, United Kingdom, SM2 5PT
Actively Recruiting
C
Caroline Martin
S
Syvella Ellis
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Have more questions? Get in touch with our team for quick support
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Amy C Lord, Brendan Moran, Muti Abulafi...
https://pubmed.ncbi.nlm.nih.gov/33033006