Improving Diagnosis and Treatment for Patients With Rectal Cancer

ConditionGI Cancer
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-99
SponsorImperial College London

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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 design

Design model

Crossover

Treatments tested in this trial

  • mrTDV

    Other intervention

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

Treatment groups

438 Participants
are divided into 3 treatment groups
Group A: Control Arm ScheduleNo intervention 0 interventions
Group B: Intervention Arm ScheduleExperimental treatment 1 intervention
Group C: Retrospective cohortNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
1 and 5 years

Secondary outcomes

1

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.

Time frame
1 and 5 years
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.

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.

Time frame
1 and 5 years
3

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

Time frame
1 and 5 years
4

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

Comparison of treatments given before and after mrTDV intervention

Time frame
6 months and 1 year

Other outcomes

Sponsors and contacts

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Imperial College London

Lead sponsor

NHS England

Collaborator

Pelican Cancer Foundation

Collaborator

This trial is not recruiting at the moment. You can still explore other options: