Pre-therapeutic MRI Assessment of Early-Stage Rectal Cancer and Significant Rectal Polyps to Avoid Major Resectional Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 46
- 主要终点
- Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.
研究概览
简要总结
When a patient is diagnosed with a rectal (bowel) polyp or cancer, radiology doctors read MRI scans to describe how deeply the cancer invades into the bowel wall (this is the 'stage' of the cancer). In this project, we will teach radiologists to find more early-stage rectal cancers. These are cancers that have only grown partially into the bowel wall. If we succeed, more patients could have these lesions removed by a local procedure that preserves the bowel and avoids the risks and complications of major surgery.
We have developed a new method for radiology doctors to read MRI scans, which is more accurate than current practice. Currently only 3/10 of early rectal cancers are found by radiologists but by using our MRI reading system, 9/10 patients can be accurately identified as having early rectal cancer. We have proven that we can teach this method to other radiology doctors whose reports help to accurately inform patients of all possible treatment options, so they can be offered the option of a local procedure.
In this initial work we will train radiology doctors in our MRI reading method in 20 hospitals. We will compare MRI reports before and after training to see if an accurate reading method improves treatments choices for patients. We will also determine whether more patients have local procedures after our training. The results of this initial work will help us to apply for national funding for a trial that we can quickly roll out to all NHS hospitals.
详细描述
Many patients diagnosed with Early Rectal Cancer (ERC) are currently over-treated. Most patients with confirmed ERC will undergo an MRI, but some are not correctly identified in endoscopy and immediately removed. Of those who undergo MRI, 69% are over-staged and undergo major surgery or unnecessary radiotherapy when local excision surgery to preserve the patients rectum, and quality of life, would have been possible. <10% of patients with ERC are staged accurately and offered local excision, with the majority who are staged as ERC on MRI still undergoing major surgery, likely due to uncertainty in the staging report.
Prof Gina Brown developed a more accurate radiological staging system (PRESERVE) or ERC, whereby T2 tumours are identified and classified according to the degree of preservation of the individual layers of the rectal wall. It has been shown that PRESERVE enabled better identification of ERC suitable for local excision from the expected 30% to 89% accuracy. This improved accuracy was replicated in a further study by training a cohort of 12 radiologists. It is predicted that wider adoption of PRESERVE will result in increased organ-preserving surgery from the current rates of 10% to >50%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a rectal tumour or suspected tumour less than or equal to T3b on MRI stage or pT2 or less after excision, or 20mm or more on endoscopy with suspicion of malignancy
- •Be aged 16 years or over
排除标准
- •Have metastatic disease at time of initial staging
- •Have a biopsy-proven rectal malignancy which is not adenocarcinoma
- •Are contraindicated for MRI
研究组 & 干预措施
Control Arm Schedule
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 transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point 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
Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . The transition period lasts one month during which recruitment is halted and two interventions implemented:
- MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
- Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
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.
干预措施: MRI scan (Diagnostic Test)
Intervention Arm Schedule
Each site will transition to the Intervention arm at a month prescribed by their randomised cluster, and from that point patients are recruited to the Intervention Arm Schedule . The transition period lasts one month during which recruitment is halted and two interventions implemented:
- MRI scans will be recommended for all rectal polyps ≥20mm in size, or with other features suspicious of malignancy, prior to removal. This is designed to reduce the numbers of Early Rectal Cancers missed in endoscopy.
- Radiologist training in the use of the PRESERVE mrSRT for suspected Early Rectal Cancer.
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.
干预措施: Radiologist training (Other)
结局指标
主要结局
Impact of a training intervention on the accuracy of the tumour staging diagnosis through systematic reporting approach to MRI scans against current (pre intervention) practice.
时间窗: 1 year
Comparison of the proportion of patients with early rectal cancer who are diagnosed by pathology vs those staged as such by MRI, before and after the intervention.
次要结局
- Proportion of patients with technically adequacate scans before and after intervention(1 year)
- Proportion of primary tumour characterised by morphology and other features associated with malignancy before and after intervention(1 year)
- Proportion of MRI reports with T substage given before and after intervention(1 year)
- Number of patients identified on imaging as suitable for rectal preservation by local excision(1 year)
- Number of patients identified by MDT as suitable for rectal preservation by local excision(1 year)
- Correlation of accuracy in the identification of safe plane of excision for rectal preservation by the radiologist(1 year)
- Numebr of patients with R0 by local excision or TME as appropriate(1 year)
- Qualitative EORTC QLQ-CR29 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery(1 year, 3 years, 5 years)
- Qualitative EORTC QLQ-CR30 Questionnaire on Quality of Life of patients undergoing local excision vs major surgery(1 year, 3 years, 5 years)
- Qualitative LARS Questionnaire on Quality of Life of patients undergoing local excision vs major surgery(1 year, 3 years, 5 years)
- Qualitative Questionnaire on Quality of Life of patients undergoing local excision vs major surgery(1 year, 3 years, 5 years)
- Comparison of total costs of procedures performed between patients undergoing local excision surgery to those undergoing major surgery(1 year)
- Comparison of inpatient costs between patients undergoing local excision surgery to those undergoing major surgery(1 year)
- Comparison of total cost of outpatient visits between patients undergoing local excision surgery to those undergoing major surgery(1 year)
- Comparison of total community costs between patients undergoing local excision surgery to those undergoing major surgery(1 year)
- Number of patients without disease and/or without stoma between patients undergoing local excision surgery, compared to those undergoing major surgery(1 year, 3 years, 5 years)
- Assessment results for the effectiveness of mrSRT after a year from training(1 year)
- Identification of histopathological biomarkers to improve selection of patients who can undergo rectal preserving strategies for Early Recal Cancer(2 months, 1 year, 3 years, 5 years)