NCT02532803: MINSTREL

Mri IN STaging REctal Polyp Planes

Status unknown NA Last updated 14 September 2018

What this trial tests

NA trial testing Novel Pelvic MRI scan assessment in Rectal Cancer in 55 participants. Status unknown.

Timeline

13 August 2015

Primary endpoint
27 July 2017

27 July 2020

Quick facts

Lead sponsor	Royal Marsden NHS Foundation Trust
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	55
Start date	13 August 2015
Primary completion	27 July 2017
Estimated completion	27 July 2020
Sites	8 locations across United Kingdom

Drugs / interventions tested

• Novel Pelvic MRI scan assessment

Conditions studied

• Rectal Cancer — all drugs for Rectal Cancer →
• Rectal Neoplasms — all drugs for Rectal Neoplasms →
• Colonic Polyps — all drugs for Colonic Polyps →

Sponsor

Royal Marsden NHS Foundation Trust

Who can join

18 and older, any sex, with Rectal Cancer or Rectal Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Magnifying chromoendoscopy is a reliable method in the selection of rectal neoplasms for local excision.
   Kimura CMS, Kawaguti FS, Horvat N, Nahas CSR, et al · · 2023 · cited 4× · PMID 36906661 · DOI 10.1007/s10151-023-02773-7