CancerIMPRESSNCT02222844
Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
A study testing Preoperative MRI scan in people with Cancer and Colorectal Neoplasms, run by Imperial College London at 16 sites in United Kingdom.
Trial summary
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Cancer, Colorectal Neoplasms, Colon, Sigmoid
- What is being tested?
- Preoperative MRI scan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 244 participants
- Where
- 16 sitesUnited Kingdom
- Study dates
- Aug 2014to Dec 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a suspected or proven sigmoid colon adenocarcinoma
- Is eligible for curative treatment
- Has no irresectable metastatic disease
- MRI can be reviewed by an MDT prior to surgery
- Has no decision regarding radical treatment
- Have provided written informed consent to participate in the study
- Be aged 16 years or over
Who cannot join
- Have metastatic disease (including resectable liver metastases)
- Have a synchronous second malignancy
- Are contraindicated for MRI
- Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
- Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
Trial locations and contacts
16 sites in 1 country. Contact the study team or a site near you to ask about taking part.
16 sites in 1 country
United Kingdom16 sites, 15 recruiting
- Recruiting
Chesterfield Royal
Chesterfield, Derbyshire, SS4 5BL
Lesley Stevenson, lesley.stevenson@nhs.net
Harjeet Singh Narula
- Recruiting
Leighton Hospital
Crewe, Cheshire, CW1 4QJ
Chris Hough, Chris.Hough@mcht.nhs.uk
Vanessa Adamson, Vanessa.Adamson@mcht.nhs.uk
- Recruiting
North Manchester General Hospital
Crumpsall, Manchester, M8 5RB
Salim Kurrimboccus, Salim.Kurrimboccus@pat.nhs.uk
Joanne Allsop, Joanne.Allsop@pat.nhs.uk
- Recruiting
Harrogate District Hospital
Harrogate, North Yorkshire, HG2 7SX
David Leinhardt
Lisa Jones, Lisa.Jones@hdft.nhs.uk
- Recruiting
Hinchingbrooke Hospital
Huntingdon, Cambridgeshire, PE29 6NT
David Mitchell, davidmitchell4@nhs.net
Susan Donnelly, susan.donnelly1@nhs.net
- Recruiting
Maidstone Hospital
Maidstone, Kent, ME16 9QQ
Paulette Basham, paulette.basham@nhs.net
Sukanya Ghosh
- Recruiting
Queen Elizabeth the Queen Mother Hospital
Margate, Kent, CT9 4AN
Sharon Turney, sharon.turney@nhs.net
Jess Evans
- Recruiting
St Mark's Hospital
Middlesex, Harrow, HA1 3UJ
Anthony Antoniou, a.antoniou1@nhs.net
Pooja Datt, pooja.datt@nhs.net
- Recruiting
Queen Alexandra Hospital
Portsmouth, Hampshire, PO6 3LY
Anthony Higginson, antony.higginson@porthosp.nhs.uk
Nicola Gibbons, nicola.gibbons@porthosp.nhs.uk
- Recruiting
Salisbury District Hospital
Salisbury, Whiltshire, SP2 8BJ
Graham Branagan, Graham.Branagan@salisbury.nhs.uk
Ruth Casey, Ruth.Casey@salisbury.nhs.uk
- Recruiting
University Hospital of North Tees
Stockton-on-Tees, County Durham, TS19 8PE
Helen Wilson, Helen.Wilson2@nth.nhs.uk
Anil Agarwal
- Recruiting
Royal Marsden Hospital
Sutton, Surrey, SM2 5PT
Cordelia Grant, cordelia.grant@rmh.nhs.uk
Irene Chong, MD
- Recruiting
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Jan Ashcroft, Jan.ashcroft@tst.nhs.uk
Erica Beaumont
- Recruiting
Croydon University Hospital
Thornton Heath, Croydon, CR7 7YE
Muti Abulafi, muti.abulafi@nhs.net
Ibiyemi Sadare, ibiyemi.sadare@nhs.net
- Recruiting
University Hospital of South Manchester & Manchester Royal Infirmary
Wythenshawe, Manchester, M23 9LT
Sarah Duff, Sarah.Duff@UHSM.NHS.UK
Lindsay Piper, Lindsay.Piper@UHSM.NHS.UK
- Active, not recruiting
Yeovil District Hospital
Yeovil, Somerset, BA21 4AT
About this study
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.
Read the detailed description
A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
- Being tested
- Preoperative MRI scan
- Keywords
- Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications
- Medical subject headings
- Neoplasms, Colorectal Neoplasms, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preoperative MRI scanOther
Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative CT scan | No intervention | CT-imaging of chest and abdomen / pelvis before surgery (standard treatment) |
| Preoperative MRI scan | Experimental | Standard treatment plus an additional MRI scan before surgery Receives: Other: Preoperative MRI scan |
| Observational | No intervention | Observational only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings
Measured: 3 years after last recruit
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI
Measured: 3 years after last recruit
Secondary outcomes (8)
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of recurrences in patients staged as low vs high risk on CT vs MRI
Measured: 3 years after last recruit
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Kaplan-Meier curves of disease free survival in patients staged as low vs high risk on CT vs MRI
Measured: 1 and 3 years after last recruit
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Grade of specimen using pathology TNM8 stratified by TNM8 staging on CT vs MRI
Measured: 5 years
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
CRM positivity rates on pathology in patients staged as low vs high risk on CT vs MRI
Measured: 3 years after last recruit
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Comparison of proportion of patients staged as low vs high risk on CT vs MRI with pathology high and low risk and against outcomes
Measured: 3 years after last recruit
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of perioperative morbidity of patients stratified by preoperative treatment between patients staged with CT vs MRI
Measured: 3 years after last recruit
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Comparison of quality of life between patients staged with CT vs MRI by questionnaire (EORTC QLQ-CR29)
Measured: 1 and 3 years after last recruit
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Comparison of proportion of stomas not reversed within 3 years postoperative follow-up in patients staged with CT vs MRI
Measured: 3 years after last recruit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionDec 2026 (estimated)
- Study completionDec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 244 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222844
- Sponsor's protocol ID
- DOCUMAS: 23HH8201
- Acronym
- IMPRESS
- Status last verified
- Oct 2024
- First submitted
- 20 Aug 2014
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers
- ClinicalTrials.gov ID
- NCT02222844
- Acronym / sponsor ID
- IMPRESS / DOCUMAS: 23HH8201
- Keywords
- Cancer, Colorectal Neoplasms, Colon, Sigmoid, Magnetic Resonance Imaging, General Surgery, Postoperative Complications
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 244 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- Pelican Cancer Foundation
- Study start
- Aug 2014 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2031 (estimated)
- First posted
- 21 Aug 2014 (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.
Patients with suspected or proven sigmoid colon adenocarcinoma, eligible for curative treatment whose MRI can be reviewed prior to surgery and has no decision regarding radical treatment are eligible. Patient are randomised to the control arm which the standard care of preoperative CT imaging and subsequent discussion by the Multidisciplinary Team or the interventional arm which has the additional use of MRI imaging and subsequent discussion by the Multidisciplinary Team. Patients are followed up at 1 and 3 years together with QoL questionnaires.
Detailed description
A randomised phase II multicentre trial, IMPRESS will determine whether the use of MRI imaging in staging sigmoid cancers results in a change to the treatment plan by identifying more high risk tumours compared to those patients who were staged using CT imaging. The proposed intervention will be additional radiological and pathological assessment and the reporting of supplementary diagnostic information which would not otherwise have been available. This may affect treatment according to local MDT protocols and also affect the provision of prognostic information to patients in subsequent discussions.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preoperative CT scan | No intervention | –CT-imaging of chest and abdomen / pelvis before surgery (standard treatment) |
| Preoperative MRI scan | Experimental | Other: Preoperative MRI scanStandard treatment plus an additional MRI scan before surgery |
| Observational | No intervention | –Observational only |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Have a suspected or proven sigmoid colon adenocarcinoma
- Is eligible for curative treatment
- Has no irresectable metastatic disease
- MRI can be reviewed by an MDT prior to surgery
- Has no decision regarding radical treatment
Key exclusion criteria (5 listed)
- Have metastatic disease (including resectable liver metastases)
- Have a synchronous second malignancy
- Are contraindicated for MRI
- Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, GFR<30)
- Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
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 |
|---|---|---|
| Preoperative MRI scanStandard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan. | Other | Preoperative MRI scan |
Primary outcome
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI.
Time frame: 3 years after last recruit
Direct comparison of proportion of patients staged as high and low risk for recurrence between CT vs MRI findings
Randomised Phase: To measure the difference in treatment stratification policy caused by the difference in staging on CT and MRI.
Time frame: 3 years after last recruit
Direct comparison of proportion of patients undergoing preoperative treatment or extended surgery between patients staged with CT vs MRI
8 secondary outcomes
To compare the recurrence rates of sigmoid tumours staged by CT and MRI according to predicted prognostic risk.
Time frame: 3 years after last recruit
To compare disease free survival of patients staged by CT and MRI according to predicted prognostic risk.
Time frame: 1 and 3 years after last recruit
To compare the quality of surgery by pathology of patients staged by CT and MRI according to predicted prognostic risk.
Time frame: 5 years
To compare CRM positivity rates on pathology of patients staged by CT and MRI according to predicted prognostic risk
Time frame: 3 years after last recruit
To compare baseline and post-treatment stage on imaging against pathology and clinical outcomes of patients staged by CT and MRI.
Time frame: 3 years after last recruit
To compare perioperative morbidity and mortality of patients staged by CT and MRI according to predicted prognostic risk.
Time frame: 3 years after last recruit
To compare quality of life of patients staged by CT and MRI according to predicted prognostic risk.
Time frame: 1 and 3 years after last recruit
To compare permanent defunctioning stoma rates in patients staged by CT and MRI according to predicted prognostic risk.
Time frame: 3 years after last recruit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2024.
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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.
Gina Brown principal investigator
Imperial College London
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Preoperative MRI scan in people with Cancer and Colorectal Neoplasms, run by Imperial College London at 16 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 7 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 17 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline Martin (+44 (0) 7749 655 817, c.martin1@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observational Phase: To measure the difference in staging of sigmoid cancer on CT and MRI. (time frame: 3 years after last recruit). The study lists 2 primary outcomes in all. 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 17 Oct 2024.