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NCT Number: NCT07054047

Improving Diagnosis and Treatment for Patients With Rectal Cancer

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.

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Key information

Conditions

GI Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases Rectal Neoplasms

Age range

16 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Southampton General Hospital, Southampton, Hampshire, United Kingdom

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

mrTDV

Other

The training of radiologists to implement specialised MRI reporting using the TDV staging system

Primary outcomes

  1. Validate that mrTDV staging can predict prognosis more accurately than mrTNM.

    Time frame: 1 and 5 years

    Survival differences for mrTNM and mrTDV before and after intervention will be compared

Secondary outcomes

  1. Assess the degree of agreement between radiologists using mrTDV method of staging rectal cancer vs mrTNM method of staging rectal cancer.

    Time frame: 1 and 5 years

    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.

  2. 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.

    Time frame: 1 and 5 years

    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.

  3. Measure the introduction of mrTDV staging and its impact on MDT decision-making with regards to treatment decisions

    Time frame: 1 and 5 years

    Comparison of what and how many treatments are offered as MDT policy to patients before and after mrTDV intervention

  4. Report changes in numbers of treatments offered following MRI-TDV staging intervention

    Time frame: 6 months and 1 year

    Comparison of treatments given before and after mrTDV intervention

  5. Report differences in disease free survival outcomes for rectal cancers staged using mrTNM method of staging versus TDV method of staging

    Time frame: 1 and 5 years

    Comparison of numbers of patients with disease free survival before and after mrTDV intervention

  6. Report differences in local recurrence rates for rectal cancers staged using mrTNM method of staging versus TDV method of staging

    Time frame: 1 and 5 years

    Comparison of numbers of patients with local recurrencebefore and after mrTDV intervention

  7. Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging

    Time frame: 6 months, 1 and 5 years

    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'

  8. Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients before and after adoption of mrTDV staging

    Time frame: 6 months, 1 and 5 years

    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'

  9. Report differences in patient LARS scores before and after adoption of mrTDV staging

    Time frame: 6 months, 1 and 5 years

    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'

  10. Report differences in patient shared decision making (SDM) before and after adoption of mrTDV staging

    Time frame: 6 months, 1 and 5 years

    Comparison of SM-Q9 scores before and after intervention. Answers are rated from 1 very poor to 7 excellent

  11. Validate an educational programme for radiologists and MDTs to improve MRI reporting with TDV staging.

    Time frame: 6 months and 1 year

    Percentage agreement of radiologists prognostic accuracy using mrTNM method of staging versus mrTDV method of staging

  12. Comparison of inpatient costs between patients before and after intervention

    Time frame: 18 and 36 months

    Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention

  13. Comparison of total cost of outpatient visits between patients before and after intervention

    Time frame: 18 and 30 months

    Comparison of total cost of outpatient episodes based on individual pathways before and after intervention

  14. Number of patients without disease and/or without stoma before and after intervention

    Time frame: 18 and 30 months

    DFS and stoma free survival in patients based on individual pathways before and after intervention

  15. Assessment of novel and existing histopathological biomarkers to improve prognostic and predictive markers

    Time frame: 6, 12, 18 months and 3, 5 years

    Comparison of relative percentage histopathological biomarkers screening panels between patients identified by the radiologist on the report before and after intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline Martin

CONTACT

[email protected]

+44 (0) 7749 655 817

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • NHS England
  • Pelican Cancer Foundation

Registry information

Official study 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)

Acronym: MERCURY 3

Important dates

Study start
2025
Primary completion
2026
Study completion
2031
First posted
Jul 8, 2025
Registry last updated
Jul 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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