Usefulness of Integrated PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 233
- 试验地点
- 1
- 主要终点
- Primary tumor staging of oropharyngeal cancer by PET/MR
研究概览
简要总结
Head and neck cancer (HNC) continues to be a significant health care problem in Taiwan and oropharyngeal squamous cell carcinoma (SCC) is the common subtype. With the concern of organ preservation in recent years, concurrent chemoradiation is the major treatment modality for oropharyngeal SCC, while endoscopy with biopsy serves as the main diagnostic tools. With the advance of MRI technology, whole body MRI is now possible, and functional techniques become more feasible in the head and neck region, including diffusion-weighted imaging (DWI) which comprises of monoexponential DWI, intravoxel incoherent motion (IVIM) model and Kurtosis (biexponential or non-Gaussian fitting), and dynamic contrast-enhanced perfusion weighted MRI (DCE-PWI) become feasible. Therefore, MRI can evaluate distant site status of HNC in the single examination session and provide biologic information of tumors. Positron emission tomography/CT (PET/CT) is another common imaging modality to evaluate HNC, because of its ability to provide whole-body anatomic and metabolic information.
Integrated PET/MRI is a novel imaging technology that combines PET and MRI in one single scanner. In this 3-year prospective study, the investigators will take the advantages of integrated PET/MRI scanner with DWI (including monoexponential, kurtosis and IVIM modes) and DCE-PWI to evaluate our 160 patients with oropharyngeal SCC subjected to chemoradiation. Non-contrast chest CT will also be performed on the same day. The investigators aim to determine whole-body staging/restaging accurately, to predict treatment response and prognosis, and to determine necessity of noncontrast chest CT. The investigators expect that this project will offer the validation of usefulness of integrated PET/MRI in tumor staging/restaging of oropharyngeal SCC and resultant clinical impact. The role of noncontrast chest CT in the workup with our PET/MRI protocol can be defined. It will also provide evidence about how and to what extent the various simultaneously acquired MRI and PET functional parameters can help prediction of treatment response and prognosis of oropharyngeal SCC subjected to chemoradiation, which are important in timely modification of treatment regimen.
详细描述
In this three-year prospective project, a total of 160 patients with histologically proven oropharyngeal SCC subjected to chemoradiation will be enrolled. Exclusion criteria include previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker, or intracranial aneurysmal ferromagnetic clips), and serum glucose level >200 mg/dl. Each enrolled patients will undergo detail clinical examination, including human papillomavirus test. The participants will undergo low dose chest CT on the same day before PET/MRI. In the posttreatment period, baseline whole body MRI will be obtained 3 months after chemoradiation. Thereafter, the participants will then be followed up also with alternative extend-field CT and whole body MRI by every 6 months. If tumor recurrenceis confirmed or highly suspected, PET/MRI will also be performed for tumor re-staging.
The three-years planning Adequate cases number and follow-up duration are essential for statistical analysis and outcome determination of oropharyngeal SCC treated with chemoradiation. The investigators plan to accomplish this study in 3 years.
In the first year, the works of the this project in the first year will design the data bank categories, set up the workflow and optimize the imaging protocols, determine the diagnostic capability of MRI component, PET component, integrated PET/MRI in tumor staging, determinate any added diagnostic value of noncontrast chest CT in integrated PET/MRI, and study the early treatment response and the patterns of residual tumor.
In the second year, the investigators will continue to the first-year works, and further include the following works to determinate incidence and predictors of treatment failure of oropharyngeal SCC, and to study the patterns of treatment response and early recurrence. In the third year, the investigators will continue to do previous work and will also get sufficient sample size to perform statistical analysis of the relationship between the imaging parameters and patient outcomes, attain comprehensive imaging about patterns of tumor recurrence and posttreatment changes/complications, investigate to what extent biologic imaging parameters may affect outcome and patient selection for chemoradiation, and analysis the accuracy, pitfalls and cost effectiveness of the PET/MRI alone and PET/MRI with noncontrast chest CT in evaluating in patients with oropharyngeal SCC.
PET/MRI data will be acquired on the integrated PET/MRI scanner , which acquires simultaneous PET and MR data with a 3.0-T magnet. The examination protocol will combined a whole-body scan with a dedicated examination of the head and neck area. All participants will fast for 6 h before the scan. At 50-70 min post injection of 370 MBq of FDG, the patient will be placed on the PET/MRI scanner bed. After fast-view T1-weighted MR localizer sequence for scout imaging and Dixon VIBE sequence for attenuation correction, a whole-body PET scan will be performed in 5 bed positions to cover from the head to the proximal thigh, with an acquisition time of 4 min per bed position. Simultaneously, whole body MR image acquisition will be performed for the corresponding 5 bed positions with the axial HASTE sequence and coronal STIR sequence as well as the sagittal T1-weighted Turbo spine echo(TSE) and STIR sequence.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically proven oropharyngeal SCC subjected to chemoradiation
排除标准
- •previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker
结局指标
主要结局
Primary tumor staging of oropharyngeal cancer by PET/MR
时间窗: 2 years
correlation of size of primary tumor(cm), size of metastatic nodes (cm), and number of distant metastasis with PET, MRI and PET/MR
次要结局
- Survival of oropharyngeal cancer by FDG uptake of PETMT(4 years)
研究者
Ng, Shu-Hang
Professor
Chang Gung Memorial Hospital
