Clinical trial · Interventional
Mri IN STaging REctal Polyp Planes
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colonic Polyps | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Rectal Neoplasms | Rectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novel Pelvic MRI scan assessment | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Novel pelvic MRI scan assessment
- 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.
- interventionNames
- Other: Novel Pelvic MRI scan assessment
Primary outcomes (1)
- measure
- Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
- timeFrame
- 6 weeks post diagnosis
Secondary outcomes (2)
- measure
- Measurement of Inter-observer Kappa agreement for stage of tumour
- timeFrame
- At diagnosis
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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).
References
Publications (0)
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