Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits
ConditionAdenocarcinoma of the Rectum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorImperial College London
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Suspected primary adenocarcinoma of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
Amenable to surgical resection.
Disease spread assessed on imaging
Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
Disqualifiers
Patients with recurrent tumours
Synchronous tumours
Under the age of 16 years
Unable to give informed consent.
Trial design
Design model
Single group
Treatments tested in this trial
MRI mapping to guide pathological sampling of extranodal tumour deposits
Diagnostic testRadiologist 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: MRI-Pathology N1c matching groupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 yearsSecondary outcomes
1
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 years2
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 years3
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 up4
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 upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Imperial College London
Lead sponsor
Pelican Cancer Foundation
Collaborator
Source ClinicalTrials.gov