Mri IN STaging REctal Polyp Planes

NCT02532803 | Unknown DMC

• 1 other identifier: CCR4346
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 8

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.

Conditions

Rectal Cancer; Rectal Neoplasms; Colonic Polyps

Keywords

Cancer; Rectum; Rectal Cancer; Polyps

Outcome Measures

Primary Outcomes (1)

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

  6 weeks post diagnosis

Secondary Outcomes (2)

• Measurement of Inter-observer Kappa agreement for stage of tumour

  At diagnosis

• Measurement of the Sensitivity and specificity of MRI for lymph node metastasis

  6 weeks after diagnosis

Study Arms (1)

Novel pelvic MRI scan assessment

EXPERIMENTAL

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

Interventions

Novel Pelvic MRI scan assessment OTHER

A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL

Novel pelvic MRI scan assessment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead
• Pelican Cancer Foundation: collaborator

Study Sites (8)

Croydon University Hospital

Thornton Heath, Croydon, CR7 7YE, United Kingdom

Location

Colchester General Hospital

Colchester, Essex, CO4 5JL, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, Hampshire, PO6 3LY, United Kingdom

Location

West Middlesex Hospital

Isleworth, London, TW7 6AF, United Kingdom

Location

Churchill Hospital

Headington, Oxford, OX3 7LE, United Kingdom

Location

Bradford Royal Infirmary

Bradford, West Yorkshire, BD9 6RJ, United Kingdom

Location

Salisbury District Hospital

Salisbury, Wiltshire, SP2 8BJ, United Kingdom

Location

Royal Marsden Hospital NHS Foundation Trust

London/Surrey, SM2 5PT, United Kingdom

Location

MeSH Terms

Conditions

Rectal Neoplasms; Colonic Polyps; Neoplasms; Polyps

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases; Intestinal Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Gina Brown

  Royal Marsden Hospital NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 18, 2015
• First Posted: August 26, 2015
• Study Start: August 13, 2015
• Primary Completion: July 27, 2017
• Study Completion: July 27, 2020
• Last Updated: September 14, 2018

Record last verified: 2018-09

Locations

GB (8)