ClinicalTrials.gg
RecruitingNCT02222844IMPRESSUpdated Oct 17, 2024

Improving Radical Treatment Through MRI Evaluation of Pelvic Sigmoid Cancers

An interventional study of Preoperative MRI scan in Cancer, Colorectal Neoplasms and Colon, Sigmoid, sponsored by Imperial College London. Recruiting at 16 sites in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2024-10-17.

Primary conditionColorectal NeoplasmsRegistry: NeoplasmsReclassifiedWhy we changed it
Registry
Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Colorectal Neoplasms
Why
  1. The study's listed conditions name Colorectal Neoplasms, a narrower term within Neoplasms.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Imperial College London · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Started Aug 2014; still recruiting 12 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
244
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 13 studies in Colorectal Neoplasms by Imperial College London — 6 open to participants now, 6 under way, none of them phase 3. Colorectal Neoplasms · Imperial College London.

Started
2014
with 1 other
No phase
4 of 13
3 open now
Registered
5th of 13
by date

Among the 13 studies in Colorectal Neoplasms by Imperial College London, this one is one of 2 that started in 2014, is one of 4 with no phase, and was the 5th registered.

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

Browse Colorectal Neoplasms studies →

Open to participants now

6 of the 13 studies in Colorectal Neoplasms by Imperial College London are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 6 open studies →

Where they have run

Who these studies take

Of the 1,185 Colorectal Neoplasms studies recruiting now, 769 (65%) set no upper age limit and 265 (22%) stop at 75 or younger; 48 take children under 18; 123 take healthy volunteers.

This study: 16 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 13 studies in Colorectal Neoplasms by Imperial College London, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Cancer
  • Colorectal Neoplasms
  • Colon, Sigmoid
  • Magnetic Resonance Imaging
  • General Surgery

Browse trials for

Keywords

  • Cancer
  • Colorectal Neoplasms
  • Colon, Sigmoid
  • Magnetic Resonance Imaging
  • General Surgery
  • Postoperative Complications
04

In context

Colorectal Neoplasms Reclassified

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 244 is above the median of 76 across 4,800 interventional studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Imperial College London is the lead sponsor of 843 studies on the registry; 180 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.

Compared within Colorectal Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Have a suspected or proven sigmoid colon adenocarcinoma
  2. Is eligible for curative treatment
  3. Has no irresectable disease
  4. MRI can be reviewed by an MDT prior to surgery
  5. Has no decision regarding radical treatment
  6. Have provided written to participate in the study
  7. Be aged 16 years or over

Exclusion criteria

Exclusion Criteria:

  1. Have disease (including resectable liver metastases)
  2. Have a synchronous second
  3. Are for MRI
  4. Are contraindicated for or have allergy to Buscopan (e.g. glaucoma, small or large bowel obstruction, \<30)
  5. Have severe co-morbidities or previous medical history that prevent the application of eventual chemo/radiotherapy
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

06

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
244 participants (estimated)

Study arms

  • No intervention
    Preoperative CT scan

    CT-imaging of chest and abdomen / pelvis before surgery (standard treatment)

  • Experimental
    Preoperative MRI scan

    Standard treatment plus an additional MRI scan before surgery

    Other: Preoperative MRI scan

  • No intervention
    Observational

    Observational only

Interventions

  • OtherPreoperative MRI scan

    Standard preoperative CT of abdomen, chest and pelvis plus interventional preoperative MRI scan.

07

What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 years after last recruit

  2. 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

    Time frame: 3 years after last recruit

Secondary outcomes

  1. 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

    Time frame: 3 years after last recruit

  2. 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

    Time frame: 1 and 3 years after last recruit

  3. 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

    Time frame: 5 years

  4. 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

    Time frame: 3 years after last recruit

  5. 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

    Time frame: 3 years after last recruit

  6. 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

    Time frame: 3 years after last recruit

  7. 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)

    Time frame: 1 and 3 years after last recruit

  8. 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

    Time frame: 3 years after last recruit

08

Study locations

15 of 16 sites recruiting
09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Aug 2014 (actual). Primary completion is estimated for Dec 2026, 148 months after the start.

Of 898 non-industry interventional studies with no phase under Colorectal Neoplasms, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 62. This study's planned 148 months is above that.

Counting every sponsor, half of 955 studies reached it within 32 months; a quarter within 14 and three quarters within 60.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 20, 2014
First posted
Aug 21, 2014
StartActual
Aug 2014
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2031
Last update
Oct 17, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02222844
Collaborators
Pelican Cancer Foundation
Responsible party
Sponsor
First posted
Aug 21, 2014
Start date
Aug 2014
Primary completion
Dec 2026 (estimated)
Completion
Dec 2031 (estimated)
Last update
Oct 17, 2024

Study contacts

Caroline Martin
Contact
c.martin1@imperial.ac.uk
+44 (0) 7749 655 817
Syvella Ellis
Contact
giclinicaltrials@imperial.ac.uk
+44 (0) 7732 315 234
Gina Brown
principal investigator · Imperial College London

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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