GI CancerMERCURY 3NCT07054047
Improving Diagnosis and Treatment for Patients With Rectal Cancer
A study testing mrTDV in people with GI Cancer, run by Imperial College London at 3 sites in United Kingdom.
Trial summary
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. Read more about this study
- Who is it for?
- Ages 16 to 99 years
- Conditions the study is for
- GI Cancer
- What is being tested?
- mrTDV
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 438 participants
- Where
- 3 sitesUnited Kingdom
- Study dates
- 1 Jul 2025to 31 May 2031
- Phase
- Interventional
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 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a rectal cancer proven on biopsy or subsequent surgery
- Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review
- Aged 16 years or over
Who cannot join
- Have irresectable metastatic disease at time of initial staging
- Undergoing palliative treatment for Rectal Cancer
- Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- Are contraindicated for MRI staging
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom3 sites
John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Site Principal Investigator, nicholas.symons@ouh.nhs.uk
Nicholas Symons
Salisbury District Hospital
Salisbury, Wiltshire, SP2 8BJ
Site Principal Investigator, Graham.Branagan@salisbury.nhs.uk
Graham Branagan
Southampton General Hospital
Southampton, Hampshire, SO16 6YD
Site Principal Investigator, Nigel.D'souza@uhs.nhs.uk
Nigel D'Souza
About this study
Official title: Improving the Prognostic Accuracy of Staging Rectal Cancer Using Magnetic Resonance Imaging (MRI) - Detected Tumour Deposits and Vascular Invasion (mrTDV) Instead of Tumour Nodal Metastasis (mrTNM)
The cancer stage information from scans guides pre-operative treatment and the type of surgery offered. The investigators are studying whether a new Magnetic Resonance Imaging (MRI) staging method can improve the accuracy of prognosis for patients diagnosed with rectal cancer. The investigators will provide consultant radiologists with the know-how to report MRI scans using this new method and compare this with the existing method. This study will test this by comparing how accurately the old versus new method predict the outcomes of patients. The existing method relies on radiologists determining if tumour has spread through the bowel wall or not and whether there are suspected malignant lymph nodes. The new method looks for tumour spread into the veins and whether or not there are tumour deposits. Our previous research has shown that the new method is much more accurate at predicting prognosis, but this finding needs to be verified by a larger multicentre study.
The investigators are also studying the patient journey, so the investigators can better understand patients' experiences and the impact that treatments have on their quality of life. The investigators wish to understand if improvements in the accuracy of prognosis from scans could change treatment decisions in future. The investigators will also compare the radiology scan prediction of prognostic factors by looking carefully at the tumour specimens.
Read the detailed description
A Retrospective and Prospective Cohort study to improve the prognostic accuracy of preoperative staging in patients diagnosed with primary rectal cancer. The intervention is the training of radiologists to implement specialised MRI reporting using the TDV staging system.
The investigators will collect anonymized scans, clinical and histopathology data from all rectal cancer patients diagnosed in 2019. The central reviewing radiologist will stage the scans by a) mrTDV and b) mrTNM into poor and good prognosis categories. The investigators will compare survival outcomes from original reports as well as the two staging systems using Kaplan-Meier and Cox Proportional-Hazard methods.
The investigators will compare prospectively collected data before and after implementation of the consensus for identifying and treating high-risk and low-risk rectal cancers. The investigators will report on the comparisons of staging, histopathology, MDT treatment decisions, resource utilisation, how patients experienced information provided for shared decision making before and after the intervention changes and quality of life measures.
- Conditions
- GI Cancer
- Being tested
- mrTDV
- Keywords
- Shared decision making, Radiotherapy, Quality of Life, MRI Staging, MDT Decision Making, Histopathological Staging, Rectal Cancer, Preoperative staging
- Medical subject headings
- Gastrointestinal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mrTDVOther
The training of radiologists to implement specialised MRI reporting using the TDV staging system
| Study group | Role | What they receive |
|---|---|---|
| Control Arm Schedule | No intervention | All sites will begin in the Control arm, with patients recruited to the Control Arm Schedule. Clinical investigations prior to treatment, during treatment, after surgery and during further treatment should be performed as per standard clinical practice and as clinically indicated. Each site will remain in the Control Arm Schedule for six months. There will be a transition month with no recruitment where training is undertaken. After the transition month patients are recruited to the Intervention Arm Schedule . Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. |
| Intervention Arm Schedule | Experimental | During the transition month, all Radiologists involved in reporting rectal cancers for the MDT will be offered training in reporting of mrTDV. Results of the retrospective data analysis will be shared at the MDT teams stakeholder meeting to determine their optimum stage based preoperative treatment decision making policy. Every site will remain in the Intervention Arm Schedule for six months.
Patients will be recruited to either the Control or Intervention arms dependent on which arm is in progress at the site at the time of recruitment. There will be no crossover of patients between the arms at any point. Receives: Other: mrTDV |
| Retrospective cohort | No intervention | Registration of all rectal cancer patients staged as non-metastatic in their site pre-treatment MDT from 1st January 2019 - 31st December 2019 should commence as soon as the site is issued the green light. The analysis of this data will be presented to their site MDT six months from the green light. Therefore, every effort should be made to complete the 2019 retrospective cohort registrations within the first three months of the trial start. We anticipate the average number of 2019 retrospective cohort patients treated for rectal cancer will be 20 per site. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Validate that mrTDV staging can predict prognosis more accurately than mrTNM.
Survival differences for mrTNM and mrTDV before and after intervention will be compared
Measured: 1 and 5 years
Secondary outcomes (15)
Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer.
Compare percentage agreement between radiologists when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Measured: 1 and 5 years
Compare percentage agreement when staging of tumours using mrTDV method of staging rectal cancer and TNM method of staging rectal cancer with respective histopathology staging for prognosis.
Compare agreement in prognostic accuracy between radiology and histopathology using when the TNM system of staging (scoring tumour, nodes and metastases) versus when using TDV system of staging (scoring tumour deposits and extramural venous invasion) is used.
Measured: 1 and 5 years
Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions
Comparison of what and how many treatments are offered as MDT policy to patients before and after mrTDV intervention
Measured: 1 and 5 years
Report changes in numbers of treatments offered following MRI-TDV staging intervention
Comparison of treatments given before and after mrTDV intervention
Measured: 6 months and 1 year
Report differences in disease free survival outcomes for rectal cancers staged using mrTNM method of staging versus TDV method of staging
Comparison of numbers of patients with disease free survival before and after mrTDV intervention
Measured: 1 and 5 years
Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging
Comparison of numbers of patients with local recurrencebefore and after mrTDV intervention
Measured: 1 and 5 years
Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging
Comparison of QoL EORTC QLQ-CR29 scores before and after intervention. Questions relate to difficulty in performing every day tasks answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 6 months, 1 and 5 years
Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging
Comparison of QoL EORTC QLQ-CR30 scores before and after intervention. Questions relate to the presences of symptoms over the previous week answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 6 months, 1 and 5 years
Report differences in patient LARS scores before and after adoption of mrTDV staging
Comparison of LARS scores before and after intervention. Questions relate to bowel function answers are rated 'Not at all' 'A Little' 'Quite a Bit' 'Very Much'
Measured: 6 months, 1 and 5 years
Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging
Comparison of SM-Q9 scores before and after intervention. Answers are rated from 1 very poor to 7 excellent
Measured: 6 months, 1 and 5 years
Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging.
Percentage agreement of radiologists prognostic accuracy using mrTNM method of staging versus mrTDV method of staging
Measured: 6 months and 1 year
Comparison of inpatient costs between patients before and after intervention
Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention
Measured: 18 and 36 months
Comparison of total cost of outpatient visits between patients before and after intervention
Comparison of total cost of outpatient episodes based on individual pathways before and after intervention
Measured: 18 and 30 months
Number of patients without disease and/or without stoma before and after intervention
DFS and stoma free survival in patients based on individual pathways before and after intervention
Measured: 18 and 30 months
Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers
Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention
Measured: 6, 12, 18 months and 3, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2025
- Study start1 Jul 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for GI 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
- Non-randomised
- Intervention model
- Crossover
- Model description
- The study will proceed through three phases: pre-intervention, intervention, and post-implementation. Pre-intervention - local MDT decisions based on current MRI reporting practices will be collected for six months. Intervention - local radiologists will be trained to recognize features of mrTDV and use a standardised reporting template. We will present the retrospective and radiologists' cohort results to MDT stakeholders who will agree the optimum stage based preoperative treatment decision making policy. We will offer training as required using the 2019 retrospective cohort. Post-intervention - local MDT decisions based on the consensus optimum stage based preoperative decision-making policy will be collected for six months.
- Masking
- None (open label)
- Enrolment
- 438 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- NHS England, Pelican Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Gina Brown, MD, Principal investigator, Imperial College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07054047
- Sponsor's protocol ID
- EDGE: 176847
- Other IDs
- 348532, 25/EM/0105
- Acronym
- MERCURY 3
- Status last verified
- Jun 2025
- First submitted
- 17 Jun 2025
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morris EJA, Finan PJ, Spencer K, Geh I, Crellin A, Quirke P, Thomas JD, Lawton S, Adams R, Sebag-Montefiore D. Wide Variation in the Use of Radiotherapy in the Management of Surgically Treated Rectal Cancer Across the English National Health Service. Clin Oncol (R Coll Radiol). 2016 Aug;28(8):522-531. doi: 10.1016/j.clon.2016.02.002. Epub 2016 Feb 28.
PubMed 26936609Wilkinson E. NICE withdraws quality standard on colorectal cancer treatment after "lack of consensus". Lancet Oncol. 2022 Mar;23(3):333. doi: 10.1016/S1470-2045(22)00084-5. Epub 2022 Feb 10. No abstract available.
PubMed 35151414Lord AC, D'Souza N, Shaw A, Rokan Z, Moran B, Abulafi M, Rasheed S, Chandramohan A, Corr A, Chau I, Brown G. MRI-Diagnosed Tumor Deposits and EMVI Status Have Superior Prognostic Accuracy to Current Clinical TNM Staging in Rectal Cancer. Ann Surg. 2022 Aug 1;276(2):334-344. doi: 10.1097/SLA.0000000000004499. Epub 2020 Sep 15.
PubMed 32941279Lord AC, Corr A, Chandramohan A, Hodges N, Pring E, Airo-Farulla C, Moran B, Jenkins JT, Di Fabio F, Brown G. Assessment of the 2020 NICE criteria for preoperative radiotherapy in patients with rectal cancer treated by surgery alone in comparison with proven MRI prognostic factors: a retrospective cohort study. Lancet Oncol. 2022 Jun;23(6):793-801. doi: 10.1016/S1470-2045(22)00214-5. Epub 2022 May 2.
PubMed 35512720