Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits (COMET)

Imperial College London

Status: Enrolling

Conditions: Adenocarcinoma of the Rectum

Treatments: Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits

Study type: Interventional

Funder types: Other

Identifiers

NCT03303547

DOCUMAS: 23HH8158

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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of the colon, sigmoid or rectum (proven by biopsy taken as part of routine clinical practice, patients to be withdrawn if not subsequently adenocarcinoma on pathology).
2. Amenable to surgical resection.
3. Disease spread assessed on imaging
4. Patients having primary surgery and those undergoing neoadjuvant treatment will be included.
5. All must have had baseline staging scans and those undergoing neoadjuvant therapy must also have had a post-treatment scan.
6. Patients aged 16 years and over

Exclusion criteria

1. Patients with recurrent tumours
2. Synchronous tumours
3. Under the age of 16 years
4. Unable to give informed consent.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

200 participants in 1 patient group

MRI-Pathology N1c matching group

Experimental group

Description:

MRI mapping will be used to guide pathologists to sample areas of the mesorectum where tumour deposits are likely to be present.

Treatment:

Diagnostic Test: MRI mapping to guide pathological sampling of extranodal tumour deposits