search
Back to results

Mri IN STaging REctal Polyp Planes (MINSTREL)

Primary Purpose

Rectal Cancer, Rectal Neoplasms, Colonic Polyps

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Novel Pelvic MRI scan assessment
Sponsored by
Royal Marsden NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rectal Cancer focused on measuring Cancer, Rectum, Rectal Cancer, Polyps

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Croydon University Hospital
  • Colchester General Hospital
  • Queen Alexandra Hospital
  • West Middlesex Hospital
  • Churchill Hospital
  • Bradford Royal Infirmary
  • Salisbury District Hospital
  • Royal Marsden Hospital NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Novel pelvic MRI scan assessment

Arm Description

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.

Outcomes

Primary Outcome Measures

Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps

Secondary Outcome Measures

Measurement of Inter-observer Kappa agreement for stage of tumour
Measurement of the Sensitivity and specificity of MRI for lymph node metastasis

Full Information

First Posted
August 18, 2015
Last Updated
September 13, 2018
Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Pelican Cancer Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT02532803
Brief Title
Mri IN STaging REctal Polyp Planes
Acronym
MINSTREL
Official Title
Mri IN STaging REctal Polyp Planes
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
August 13, 2015 (Actual)
Primary Completion Date
July 27, 2017 (Actual)
Study Completion Date
July 27, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Royal Marsden NHS Foundation Trust
Collaborators
Pelican Cancer Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer, Rectal Neoplasms, Colonic Polyps
Keywords
Cancer, Rectum, Rectal Cancer, Polyps

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Novel pelvic MRI scan assessment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Novel Pelvic MRI scan assessment
Intervention Description
A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL
Primary Outcome Measure Information:
Title
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
Time Frame
6 weeks post diagnosis
Secondary Outcome Measure Information:
Title
Measurement of Inter-observer Kappa agreement for stage of tumour
Time Frame
At diagnosis
Title
Measurement of the Sensitivity and specificity of MRI for lymph node metastasis
Time Frame
6 weeks after diagnosis

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Brown
Organizational Affiliation
Royal Marsden Hospital NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Croydon University Hospital
City
Thornton Heath
State/Province
Croydon
ZIP/Postal Code
CR7 7YE
Country
United Kingdom
Facility Name
Colchester General Hospital
City
Colchester
State/Province
Essex
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
Queen Alexandra Hospital
City
Portsmouth
State/Province
Hampshire
ZIP/Postal Code
PO6 3LY
Country
United Kingdom
Facility Name
West Middlesex Hospital
City
Isleworth
State/Province
London
ZIP/Postal Code
TW7 6AF
Country
United Kingdom
Facility Name
Churchill Hospital
City
Headington
State/Province
Oxford
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Bradford Royal Infirmary
City
Bradford
State/Province
West Yorkshire
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Salisbury District Hospital
City
Salisbury
State/Province
Wiltshire
ZIP/Postal Code
SP2 8BJ
Country
United Kingdom
Facility Name
Royal Marsden Hospital NHS Foundation Trust
City
London/Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

Mri IN STaging REctal Polyp Planes

We'll reach out to this number within 24 hrs