An interventional study of MRI mapping to guide pathological sampling of extranodal tumour deposits in Adenocarcinoma of the Rectum, sponsored by Imperial College London. Recruiting at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.
Sponsored by Imperial College London · Not applicable, Interventional, and Treatment
Any patient with a suspected primary adenocarcinoma of the colon, sigmoid or rectum undergoing surgery are eligible. The date of surgery must be known prior to registration. This trial aims to determine if image mapping techniques can improve the concordance between imaging and pathology detection of tumour deposits. Lymph nodes and tumour deposits will be identified on pre-operative scans and mapped by radiologists then shared with pathologists prior to processing the resected specimen. Patients will be managed at their local hospital with standard follow-up. Patients will be followed up for 5 years.
A prospective interventional multi-centre study, COMET aims to prove the accuracy of imaging diagnosis of extranodal tumour deposits (TD) and their adverse effect on prognosis of colorectal cancers. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
1,804 studies on the registry are indexed under Rectal Neoplasms; 520 are open to participants now.
This study's planned enrollment of 200 is above the median of 66 across 1,330 interventional studies indexed under Rectal Neoplasms.
Browse Rectal Neoplasms studies →Imperial College London is the lead sponsor of 842 studies on the registry; 180 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
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Exclusion Criteria:
MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.
Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits
Radiologist to mark areas where extranodal disease is identified on MRI. The pathologist will use this to take additional samples for analysis. This will allow better pathological staging and will affect treatment decisions for patients.
To determine whether the prevalence of TD on pathology is found to be higher if imaging mapping is used.
Comparison of the proportion of patients with TD on imaging with proportion of patients with TD on histopathology defined as 'nodules without definite features of lymph node architecture'
Time frame: Up to 2 years
To determine whether lesions classified as TD on Imaging correspond to the pathological diagnosis of TD.
Correspondence of nodules identified as tumour deposits on imaging and nodules identified as tumour deposits on the corresponding pathology slice
Time frame: Up to 2 years
To determine the effect of Imaging and pathological diagnosis of TD on disease free survival (at one, three and five years), overall survival (at one, three and five years) and time to local recurrence.
Survival and recurrence outcomes according to Imaging and histopathology TD status
Time frame: 1, 3 and 5 years
To investigate features of the primary tumour compared with tumour deposits
Comparison of immunohistochemical and morphological features of tumour
Time frame: Up to 2 years and up to 5 years follow up
To investigate features of the primary tumour compared with lymph nodes
Comparison of immunohistochemical and morphological features of tumour
Time frame: Up to 2 years and up to 5 years follow up
To objectively record the features seen which help distinguish a LN from an TD and attempt to refine and clarify the definitions used in pathology.
Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
Time frame: Up to 2 years
To objectively record the features seen which help distinguish a LN from an TD
Comparison of histopathological known features in patients with MR defined TD vs lymph nodes e.g. capsule, peripheral lymphocyte ring, vessel wall, "lone arteriole sign"
Time frame: Up to 2 years
To assess inter-observer agreement between the local pathologist and the central reviewing pathologist.
Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
Time frame: Up to 2 years0
To assess inter-observer agreement between the local radiologist and central reviewing radiologist.
Overall comparison of professional agreement between specialists on TD status at recruiting site vs central review - description of location and number of tumour deposits
Time frame: Up to 2 years
Plan to share: No
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