Rectal CancerMINSTRELNCT02532803
Mri IN STaging REctal Polyp Planes
A study testing Novel Pelvic MRI scan assessment in people with Rectal Cancer and Rectal Neoplasms, run by Royal Marsden NHS Foundation Trust at 8 sites in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer, Rectal Neoplasms, Colonic Polyps
- What is being tested?
- Novel Pelvic MRI scan assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 8 sitesUnited Kingdom
- Study dates
- 13 Aug 2015to 27 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United Kingdom8 sites
Bradford Royal Infirmary
Bradford, West Yorkshire, BD9 6RJ
Colchester General Hospital
Colchester, Essex, CO4 5JL
Churchill Hospital
Headington, Oxford, OX3 7LE
West Middlesex Hospital
Isleworth, London, TW7 6AF
Royal Marsden Hospital NHS Foundation Trust
London/Surrey, SM2 5PT
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
Croydon University Hospital
Thornton Heath, Croydon, CR7 7YE
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Rectal Cancer, Rectal Neoplasms, Colonic Polyps
- Being tested
- Novel Pelvic MRI scan assessment
- Keywords
- Cancer, Rectum, Rectal Cancer, Polyps
- Medical subject headings
- Rectal Neoplasms, Colonic Polyps, Neoplasms, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Pelvic MRI scan assessmentOther
A novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Novel Pelvic MRI scan assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
Measured: 6 weeks post diagnosis
Secondary outcomes (2)
Measurement of Inter-observer Kappa agreement for stage of tumour
Measured: At diagnosis
Measurement of the Sensitivity and specificity of MRI for lymph node metastasis
Measured: 6 weeks after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2015 (estimated)
- Study start13 Aug 2015
- Primary completion27 Jul 2017
- Study completion27 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Royal Marsden Hospital NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02532803
- Sponsor's protocol ID
- CCR4346
- Acronym
- MINSTREL
- Status last verified
- Sep 2018
- First submitted
- 18 Aug 2015
- Last updated
- 14 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mri IN STaging REctal Polyp Planes
- ClinicalTrials.gov ID
- NCT02532803
- Acronym / sponsor ID
- MINSTREL / CCR4346
- Conditions
- Rectal Cancer, Rectal Neoplasms, Colonic Polyps
- Keywords
- Cancer, Rectum, Rectal Cancer, Polyps
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- 13 Aug 2015 (actual)
- Primary completion
- 27 Jul 2017 (actual)
- Study completion
- 27 Jul 2020 (estimated)
- First posted
- 26 Aug 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel pelvic MRI scan assessment | Experimental | Other: Novel Pelvic MRI scan assessmentAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Novel Pelvic MRI scan assessmentA novel MRI assessment of early rectal cancers will be provided for all patients in MINSTREL | Other | Novel pelvic MRI scan assessment |
Primary outcome
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps
Time frame: 6 weeks post diagnosis
2 secondary outcomes
Measurement of Inter-observer Kappa agreement for stage of tumour
Time frame: At diagnosis
Measurement of the Sensitivity and specificity of MRI for lymph node metastasis
Time frame: 6 weeks after diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gina Brown principal investigator
Royal Marsden Hospital NHS Foundation Trust
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Pelvic MRI scan assessment in people with Rectal Cancer and Rectal Neoplasms, run by Royal Marsden NHS Foundation Trust at 8 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurement of the accuracy of a novel MRI assessment tool to accurately stage Early Rectal Cancers and Polyps (time frame: 6 weeks post diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2018.