Clinical trial · Interventional
Improving Diagnosis and Treatment for Patients With Rectal Cancer
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| GI Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| mrTDV | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- NO_INTERVENTION
- label
- Control Arm Schedule
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention Arm Schedule
- description
- 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.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Have a rectal cancer proven on biopsy or subsequent surgery 2. Sites able to submit anonymised MRI staging scans, pathology and imaging reports for central review 3. Aged 16 years or over Exclusion Criteria: 1. Have irresectable metastatic disease at time of initial staging 2. Undergoing palliative treatment for Rectal Cancer 3. Have a biopsy-proven rectal malignancy which is not adenocarcinoma 4. Are contraindicated for MRI staging
References
Publications (4)
- BACKGROUNDMorris 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. PMID 26936609
- BACKGROUNDWilkinson 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. PMID 35151414
- BACKGROUNDLord 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. PMID 32941279
- BACKGROUNDLord 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. PMID 35512720