Usefulness of Integrated PET/MRI in Oropharyngeal Squamous Cell Carcinoma Evaluation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Treatment response and prognosis
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. Endoscopy with biopsy serve as the main diagnostic tools in patients with oropharyngeal SCC. While computed tomography (CT) and magnetic resonance imaging (MRI) are commonly used to evaluate the tumor extent of HNC, MRI is more preferred in the oropharyngeal area by virtue of its high contrast resolution. 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, IVIM (intravoxel incoherent motion) model and Kurtosis (biexponential or non-Gaussian fitting), and perfusion-weighted imaging (PWI) become feasible. Therefore, MRI can evaluate distant site status of HNC in the single examination session and provide biologic information of tumors, such as cellularity, angiogenesis and permeability, and so forth. 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. It can acquire both PET and MRI information simultaneously. Initial data convey that PET/MRI performed favorably in diagnostic evaluation of HNC. However, the predictive value of PET/MRI in treatment outcome of HNC has not been reported. A prospective study of integrated PET/MRI in a large cohort of patients with specific tumor origin and uniform treatment protocol is needed to fully validate the clinical usefulness of this novel integrated system.
In this 3-year prospective study, the investigators will take the advantages of integrated PET/MRI scanner with diffusion-weighted MRI (DWI) and dynamic contrast-enhanced perfusion weighted MRI (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 (1) determine whole-body staging/restaging accurately, (2) predict treatment response and prognosis, and (3) 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 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, which are important in timely modification of treatment regimen.
详细描述
Introduction and aim of study:
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. Hence, accurate tumor anatomic and biologic evaluations are warranted for pretreatment planning, posttreatment monitoring and prognosis determination. Endoscopy with biopsy serve as the main diagnostic tools in patients with oropharyngeal SCC. While computed tomography (CT) and magnetic resonance imaging (MRI) are commonly used to evaluate the tumor extent of HNC, MRI is more preferred in the oropharyngeal area by virtue of its high contrast resolution, particularly in detecting perineural invasion. Whole body MRI is now feasible and thus distant site status of HNC can be evaluated in the single examination session. FDG- positron emission tomography/CT (PET /CT) is another common imaging modality to evaluate HNC.
According to the investigators' experience in patients with head and neck cancer, MRI and PET/CT have different advantages over each other and may complement to each other. In evaluating primary tumor status, the high spatial and contrast resolution of MRI can delineate the tumor extent from surrounding normal tissue in the complex head and neck anatomical region, while delineation of FDG-positive tissue by PET may help differentiation tumor growth from surrounding noncancerous tissue, particularly in irradiated bed. In evaluating regional nodal status, MRI is superior to PET/CT in detecting retropharyngeal or cystic necrotic metastatic adenopathy, whereas PET/CT excels MRI in detecting metastasis in sub-centimeter nodes. The combined use of MRI and PET can clearly demonstrate the patterns of nodal spread.[7]. Regards to the evaluation of the distant sites, whole body MRI is better in detecting metastatic lesion in high metabolic organs such as brain, liver or spleen, while PET/CT is superior in detecting those metastatic lesions in the curved, flat bones, and second primary bowel tumor such as esophagus cancer or colon cancer.
Currently, diffusion-weighted MR imaging (DWI) and dynamic contrast-enhanced perfusion weighted imaging (DCE-PWI) become clinically feasible to assess the functional aspects of HNC. The quantified parameter of DWI sequence is apparent diffusion coefficient (ADC) that relates to cellularity. DCE-PWI provides the volume transfer rate constant (Ktrans), relative extravascular extracellular space (Ve) and relative vascular plasma volume (Vp) as well as the efflux rate constant (Kep). These functional MRI techniques may provide biologic information, such as cellularity, angiogenesis and permeability. On the other hand, PET can provide its metabolic quantified parameters: standardized uptake value (SUV) that reflects glucose metabolism, metabolic tumor volume (MTV) that reflects tumor burden, and total lesion glycolysis (TLG) that integrates both glucose metabolism and tumor burden. These MRI and PET functional parameters appear promising for predicting chemoradiation response and prognosis of HNC. In our previous studies of oropharyngeal or hypopharyngeal SCC patients, Ktrans of the primary tumor was the only imaging parameter associated with local control, while ADC and Ve values of the neck metastatic nodes were independent prognostic factors for neck control. The maximal SUV of the regional lymph nodes was significantly associated with the occurrence of distant metastasis. TLG were significantly associated with overall survival.
Integrated PET/MRI is a novel imaging technology introduced into the clinical practice. The combination of PET and MRI in one single, hybrid scanner is promising. Initial data convey that PET/MRI performed favorably for HNC. It showed good diagnostic capability similar to PET/CT and can serve as a legitimate alternative to PET/CT in the clinical workup of patients with HNC. The metabolic ratios measured PET/MRI showed excellent agreement with those on standard PET/CT. PET/MRI incorporating the Dixon sequence for attenuation correction purposes yielded similar SUV values when compared to PET/CT.Nevertheless, most studies were limited in number of cases or no particular tumor entity was specifically analyzed, which somewhat weakened their power in terms of evidence-based medicine. In addition, the predictive value of PET/MRI in treatment outcome of HNC has not been reported. A prospective study of PET/MRI in a large cohort of patients with specific tumor origin and uniform treatment protocol would complement these pioneering efforts to fully validate the clinical usefulness of the novel integrated system.
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
- 20 Years 至 80 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
- •Exclusion criteria include previous head or neck malignant tumor, a second malignant tumor, distant metastasis, contraindications to MRI (renal insufficiency, cochlear implant, cardiac pacemaker placement or intracranial aneurysmal ferromagnetic clips), and serum glucose level >200 mg/dl.
结局指标
主要结局
Treatment response and prognosis
时间窗: 3 years
We aim to obtain MRI and PET functional results and evaluate for the predictive values of integrated PET/MRI system in the single imaging session of the patient cohort of oropharyngeal SCC uniformly treated with chemoradiation, and also to evaluate the clinical usefulness of the various functional parameters of integrated PET/ MRI in avoiding unnecessary or fruitless treatments.
Whole-body staging/restaging using integrated PET/MRI
时间窗: 3 years
The feasibility and accuracy of integrated PET/MRI in detection of locoregional tumor extent, regional nodal metastases and distant metastases for staging and tailored treatment of oropharyngeal SCC of the 160 participants.
Necessity of noncontrast chest CT
时间窗: 3 years
To prospectively validate the performance of our integrated PET/MRI protocol sequences for lung lesions by comparing with a noncontrast enhanced CT for detection of subtle lung metastases for the patient cohort.
次要结局
未报告次要终点
