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Mri IN STaging REctal Polyp Planes (MINSTREL)

13 september 2018 bijgewerkt door: 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.

Studie Overzicht

Toestand

Onbekend

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Verwacht)

55

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Diagnostisch
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: 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.
Ander: Novel Pelvic MRI scan assessment
A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
Tijdsspanne: 6 weeks post diagnosis
6 weeks post diagnosis

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Royal Marsden NHS Foundation Trust

Medewerkers

Pelican Cancer Foundation

Onderzoekers

  • Hoofdonderzoeker: Gina Brown, Royal Marsden Hospital NHS Foundation Trust

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

13 augustus 2015

Primaire voltooiing (Werkelijk)

27 juli 2017

Studie voltooiing (Verwacht)

27 juli 2020

Studieregistratiedata

Eerst ingediend

18 augustus 2015

Eerst ingediend dat voldeed aan de QC-criteria

21 augustus 2015

Eerst geplaatst (Schatting)

26 augustus 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

14 september 2018

Laatste update ingediend die voldeed aan QC-criteria

13 september 2018

Laatst geverifieerd

1 september 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • CCR4346

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