Diagnostic Accuracy of Positron Emission Tomography/ Computed Tomography With 18F-fluoro-2-deoxyglucose (18F- FDG PET/CT) in Patients With Colorectal Cancer
试验速览
- 阶段
- 不适用
- 入组人数
- 45
- 主要终点
- How many patients will be upstaged or downstaged by using pre-operative F-18 FDG_PET/CT in patients with colorectal cancer.
研究概览
简要总结
Colorectal cancer (CRC) is the fourth most frequently diagnosed cancer and the second leading cause of cancer death in the United States.
The overall relative 5-year survival is about 50%-60% but is highly dependent on disease stage at the time of diagnosis ranging from approximately 80% to only 3%.
Curative treatment comprises resection of the primary tumour combined with adjuvant chemotherapy in selected patients. In recent years there has been an increasing role for curative intended surgical or ablative intervention in limited metastatic disease, i.e., solitary or few metastases to the liver and/or the lungs. Accurate preoperative staging is of paramount importance for directing the most appropriate therapeutic options, for indicating prognosis and outcome, and to avoid futile operations.
详细描述
The use of imaging in the staging and restaging of colorectal cancers has been evolving and improving in the last two decades. Magnetic resonance imaging (MRI) is an accepted modality for staging of rectal cancer, allowing an accurate identification of transmural invasion of the mesorectal fat and mesorectal fascia involvement. Computed tomography (CT) significantly lacks resolution of soft tissue contrast so that its utility in T staging of rectal cancer is limited. Due to the higher sensitivity and specificity compared with CT,Positron Emission Tomography/ Computed Tomography with 18F-fluoro-2-deoxyglucose (FDG PET/CT) is recommended for use in a metastatic patients.
Pelvic MRI and 18F-FDG PET/CT are useful for staging and therapeutic management. Pelvic MRI allows for accurate definition of the distance to mesorectal fascia which is a predictor of the local recurrence rate, as well as for definition of the regional nodal status. 18F-FDG PET/CT also helps in evaluating the nodal status and is especially performed for the detection of distant metastases. MRI and 18F-FDG PET/CT are thus 2 complementary modalities for the initial staging of advanced rectal cancer.
Neoadjuvant therapies are performed for stage II and stage III rectal cancer. It has been shown that neoadjuvant therapy decreases local recurrence and increases survival. Therefore, correct preoperative staging has a critical role in determining whether patients should undergo neoadjuvant therapy.
The literature on the clinical use of FDG-PET/CT in colorectal cancer staging is fairly limited, but recent works have demonstrated some promise for optimizing the accuracy of initial staging by clarifying equivocal findings on conventional imaging in preoperative staging, and evaluating apparently limited metastatic disease before intervention .
It was reported that the use of FDG-PET/CT in this study changed the planned treatment strategy in a total of 30% of the patients. A change from palliative to curative or vice versa was seen in almost 10% of the patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pathologically proven colorectal cancer presented for pre-operative staging or restaging.
- •Patients with treated colorectal cancer , suspecting recurrence .
排除标准
- •Pregnancy.
- •Patients with double primary.
- •Expected life less than 3 months.
- •Uncontrolled diabetes or elevated blood sugar more than 200 mg/dl.
- •Severe medical condition.
结局指标
主要结局
How many patients will be upstaged or downstaged by using pre-operative F-18 FDG_PET/CT in patients with colorectal cancer.
时间窗: 2 weeks after the patients have been diagnosed and presented for treatment
role of F-18 FDG_PET/CT in staging of colorectal cancer patient .
次要结局
- Number of patients will be diagnosed recurrent colorectal cancer by using F-18 FDG_PET/CT in case of negative other conventional imaging.(one week)
研究者
Shymaa Mohamed
principle investigator
Assiut University