Mri IN STaging REctal Polyp Planes (MINSTREL)

September 13, 2018 updated by: Royal Marsden NHS Foundation Trust

Early cancers of the rectum can be removed safely through the anus without subjecting patients to major abdominal surgery in a procedure called TEMS (transanal endoscopic microsurgery). Patients undergoing TEMS can benefit from reduced mortality, impotence, hospital stay and avoiding a stoma that may be associated with pelvic surgery.

Currently few of the patients eligible for TEMS are offered it for a variety of reasons that include uncertainties about the risk of leaving residual tumour and the increased risk of subsequent recurrence of cancer within the pelvis. Current UK guidelines state there is no role for imaging in assessing the malignant polyp. Conversely whilst retrospectively reviewing their MRI databank the investigators have found evidence that MRI can accurately judge the depth of these early tumours and thereby potentially identify patients for local excision.

The investigators hope to prospectively test their hypothesis that an MRI scan can accurately gauge depth of tumour spread in an unselected group of benign and malignant tumours measuring between 20mm and 50mm in size.

The investigators will identify eligible patients awaiting surgery / polypectomy and if they consent to this pilot study participants will undergo an MRI to assess their tumour which assesses safety at all levels of the rectal wall. The accuracy of MRI can then be established by reference to gold standard histopathology. Should MRI prove sensitive and specific then the investigators hope to change national guidelines to mandate MRI to standardise assessment and thereby increase the appropriate use of TEMS in the UK.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Data published by the NBOCAP in 2014 shows 45% of the 9,433 rectal cancers treated in the UK annually were either T1 or T2 and 66% were node negative. Despite this 77% of those operated on underwent major resection whilst only 11% were locally excised.

Rectal tumours are heterogenous and endosocpic biopsy is an unreliable way to exclude malignancy. Objective endoscopic criteria applied to assess lesion morphology and pit pattern mostly have an evidence base derived from international single centre trials and the accuracy and variable use in UK routine practice remains un-audited. Endorectal ultrasound is rarely used and in routine practice has shown to be inaccurate. Of the early rectal cancers submitted to the UK TEM database, 44% of pT1 and 31% of pT2 cancers were incorrectly presumed to be benign preoperatively. Pre operatively considering a lesion benign when in fact it is malignant is associated with a hazard 1.98 of leaving residual disease after excision with TEMS.

High-Spatial-Resolution magnetic resonance imaging (MRI) is a standard of care in assessing the circumferential resection margin of rectal tumours and triaging patients with more advanced tumours to neoadjuvant therapy to reduce local recurrence. MRI is the established modality for identifying rectal cancer position, the relationship of tumour to the peritoneal reflection, is less user dependent than ultrasound, provides reliable information about extramural disease and is available in all centres that operate on rectal cancer. There is a paucity of evidence base clarifying the current accuracy of MRI in assessing T stage and lymph node involvement in early rectal cancer.

Eligible patients will be identified on colonoscopy if they are found to have a 20mm to 50mm rectal tumour within 150mm of the anal verge. Endoscopic assessment +/- ultrasound +/- biopsies may be taken as per local policy for review at the local multidisciplinary team meeting. Patients will be invited to participate in the trial after the index colonoscopy. Patients will have fully recovered from the endoscopy and any sedation given before being approached to join the trial.

All patients who enter the trial will be sent for an MRI. The MRI will be reported using a novel staging proforma. The results of all the staging investigations, the MRI and any biopsy will be made available to the clinician and any MDT discussion. The patients will proceed to excision or resection of the tumour as per clinician / MDT discussion.

Patients will be followed up as per routine NHS care as determined by local polyp surveillance protocol or MDT discussion.

Study Type

Interventional

Enrollment (Anticipated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London/Surrey, United Kingdom, SM2 5PT
        • Royal Marsden Hospital NHS Foundation Trust
    • Croydon
      • Thornton Heath, Croydon, United Kingdom, CR7 7YE
        • Croydon University Hospital
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JL
        • Colchester General Hospital
    • Hampshire
      • Portsmouth, Hampshire, United Kingdom, PO6 3LY
        • Queen Alexandra Hospital
    • London
      • Isleworth, London, United Kingdom, TW7 6AF
        • West Middlesex Hospital
    • Oxford
      • Headington, Oxford, United Kingdom, OX3 7LE
        • Churchill Hospital
    • West Yorkshire
      • Bradford, West Yorkshire, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary
    • Wiltshire
      • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
        • Salisbury District Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged over 18 years of age presenting with 20 to 50mm tumours found at flexible sigmoidosocpy /colonoscopy presumed either adenoma or adenocarcinoma.
  • Patients must be able to undergo colonoscopy, adequate bowel preparation, MRI, and surgery if necessary.

Exclusion Criteria:

  • Patients who are unable to consent, who withhold consent or who withdraw consent will be excluded.
  • Patients will be excluded if they have a contraindication to MRI (e.g. intraocular metal fragments, certain pacemakers, severe claustrophobia).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Novel pelvic MRI scan assessment
All patients with rectal tumours of 20-50mm in size who consent to enter the trial will receive novel staging report for their pelvic MRI scan.
Other: Novel Pelvic MRI scan assessment
A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
Time Frame: 6 weeks post diagnosis
6 weeks post diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Measurement of Inter-observer Kappa agreement for stage of tumour
Time Frame: At diagnosis
At diagnosis
Measurement of the Sensitivity and specificity of MRI for lymph node metastasis
Time Frame: 6 weeks after diagnosis
6 weeks after diagnosis

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Marsden NHS Foundation Trust

Collaborators

Pelican Cancer Foundation

Investigators

  • Principal Investigator: Gina Brown, Royal Marsden Hospital NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 13, 2015

Primary Completion (Actual)

July 27, 2017

Study Completion (Anticipated)

July 27, 2020

Study Registration Dates

First Submitted

August 18, 2015

First Submitted That Met QC Criteria

August 21, 2015

First Posted (Estimate)

August 26, 2015

Study Record Updates

Last Update Posted (Actual)

September 14, 2018

Last Update Submitted That Met QC Criteria

September 13, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCR4346

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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