A Prospective Study Evaluating Diagnostic Accuracy, Outcome, and Economic Impact of Abbreviated Gadoxetate-enhanced MRI of the Liver in Patients With Metastatic Colorectal Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of abbreviated versus full MRI protocol
研究概览
简要总结
After a patient is diagnosed with colon cancer, they receive a CT of the chest, abdomen, and pelvis to see if the cancer has spread (metastasized) to other parts of the body. A common site for the cancer to spread to is the liver. If an abnormality is seen in the liver on CT, sometimes an MRI of the liver is required to determine a) whether it is cancer or not and b) whether there are small tumours in the liver that were not visible on CT.
During the MRI, the patient is injected with intravenous (IV) contrast. This makes liver lesions more conspicuous and also helps determine if they are cancerous or not. The most commonly used IV contrast agent is called Gadovist. However, there is another IV contrast agent called Primovist that is better at detecting liver metastases from colon cancer than Gadovist. This is very important information for surgeons, because if they considering cutting out (resecting) the liver tumours, they want to make sure they get them all.
Unfortunately, Primovist is used sparingly in Canadian hospitals because it is more expensive than Gadovist and the MRI takes longer. Some early small studies have suggested that it may be possible to shorten the Primovist MRI significantly (e.g. from 60 minutes to 15 minutes), making it economically feasible to offer Primovist to more patients. However, there have not been any large studies performed to confirm these findings.
The purpose of this study is to compare the accuracy of colon cancer liver metastasis detection between a regular, full-length Primovist MRI versus a shortened Primovist MRI protocol. The economic impact will also be assessed.
详细描述
BACKGROUND
Colorectal cancer (CRC) is the third most commonly diagnosed cancer in Canada and the second leading cause of death in both men, and women (1). In 2021, 24800 Canadians were diagnosed with CRC and 9,600 died from the disease (1). Over their lifetime, 1 in 18 Canadians will be diagnosed with CRC and 1 in 37 will die (1). Accurate staging is essential to improving outcomes, providing appropriate patient management, and improving the health care costs associated with caring for patients with CRC.
London Health Sciences Centre (LHSC) is a tertiary care referral centre for a catchment area of 2 million people in Southwestern Ontario. Annually, approximately 200 patients present to the London Regional Cancer Program with a diagnosis of colorectal cancer. Of these, about 100 patients will have potentially resectable colorectal liver metastasis (CRCLM).
Staging algorithms for CRC include contrast enhanced computed tomography (CECT) of the thorax/abdomen/pelvis, with MRI of the liver in some centres. The objective for performing imaging tests is to accurately determine the extent of local and distant disease to direct patient management. Accurate assessment of the hepatic disease burden is crucial for surgical planning since resection of liver metastases is a core component of CRCLM treatment (2). At LHSC, all patients are initially imaged with CECT of the thorax/abdomen/pelvis. MRI of the liver is reserved for patients that require further characterization of equivocal liver lesions detected on CT. When performed, liver MRI is often performed with extracellular agents such as gadobutrol (Gadovist), i.e. EC-MRI.
Hepatobiliary MRI contrast agents such as gadoxetic acid (aka gadoxetate, trade name Primovist in Canada), i.e. EOB-MRI, provide superior accuracy in detection of CRCLM compared to both CECT (3) and EC-MRI (4). Moreover, the use of EOB-MRI can alter management decisions and improve patient outcomes (3,5,6). It is also the modality of choice in CRCLM patients post-systemic therapy as per the 9th International Forum for Liver MRI Consensus Report (7).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 18 years of age or older
- •Diagnosis of colorectal cancer, biopsy proven
- •Prior imaging showing liver lesions that may be metastases
- •Provision of signed and dated informed consent form
- •Willingness to comply with study procedures and availability for the duration of the study
- •Able to tolerate MRI required by protocol
排除标准
- •Presence of implanted medical device or metallic object that is MR incompatible
- •Baseline eGFR of < 30 mL/min/1.73 m2
- •Severe claustrophobia not relieved by oral anxiolytics
- •Documented severe allergic-like reaction gadolinium-based contrast agent
- •Weight greater than allowable on MRI table
- •Pregnancy
- •Diffuse liver metastases, i.e. definitively unresectable
- •Severe liver dysfunction, ALBI grade 3
研究组 & 干预措施
Full Protocol
Routine Primovist MRI
干预措施: Full Gadoxetate-enhanced liver MRI (Diagnostic Test)
Abbreviated Protocol
Shortened Primovist MRI
干预措施: Shortened Gadoxetate-enhanced liver MRI (Diagnostic Test)
结局指标
主要结局
Diagnostic accuracy of abbreviated versus full MRI protocol
时间窗: 2 years
Sensitivity, specificity, area under ROC curve
次要结局
- Cost of abbreviated versus full MRI protocol(3 years)
- Overall survival at 1 year post abbreviated versus full MRI protocol(3 years)
- Progression free survival at 1 year post abbreviated versus full MRI protocol(3 years)
- Diagnostic accuracy of simulated abbreviated versus full MRI protocol(2 years)
- Inter-reader agreement for all modalities(2 years)
- Overall survival at 1 year post abbreviated versus full MRI protocol(3 years)
- Cost of abbreviated versus full MRI protocol(3 years)
- Cancer specific survival at 1 year post abbreviated versus full MRI protocol(3 years)
- Progression free survival at 1 year post abbreviated versus full MRI protocol(3 years)
- Diagnostic accuracy of simulated abbreviated versus full MRI protocol(2 years)
- Inter-reader agreement for all modalities(2 years)
研究者
Harry Marshall
Assistant Professor of Radiology
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's