Use of Multiparametric Magnetic Resonance Imaging in the Management of Head and Neck Cancer: a Prospective Analysis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- discriminatory value of MRI D value between tumoural and non-tumoural cervical lymph nodes
研究概览
简要总结
The investigators aim to validate specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
详细描述
Background: The locoregional control rates in patients with advanced head and neck cancer remain suboptimal. Accurate diagnosis of metastatic cervical lymph nodes, bone invasion, or tumour relapse in a previously irradiated or operated field remains challenging. Technological advances in magnetic resonance imaging (MRI) enable to quantify diffusion and perfusion of the tumour and its surrounding tissues, which could improve diagnostic performance. Moreover, they could provide additional information about radiation and/or chemotherapeutic efficiency in an individual patient.
Objectives: The investigators aim to validate specific MRI parameters that could improve diagnostic accuracy of metastatic cervical lymph nodes in patients with a squamous cell carcinoma in the head and neck region. Moreover, we aim to explore specific MRI parameters that could improve diagnostic accuracy of bone invasion and tumour relapse, as well as predict treatment response and survival in this target population.
Methods: In this trial, a validation cohort will be recruited in a prospective manner, to validate the MRI parameters that showed clinically acceptable discriminant value based on the retrospective study. The values of the selected MRI parameters will be calculated in metastatic lymph nodes of the affected group, for comparison with their values measured in the lymph nodes of a prospectively recruited control group, comprising patients who require the same standardized MRI protocol for evaluation of a Whartin tumour or pleomorphic adenoma of the parotid gland without malignant transformation, and in whom both the parotid gland lesion and the cervical lymph node are surgically removed for histological confirmation. All included patients of the 'affected group' will also undergo a preoperative positron emission tomography-computed tomography (PET-CT), according to international guidelines, and will preferably receive a multiparametric MRI at 3, 6, 12, 24, 36, 48 and 60 months post treatment as part of routine follow-up.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Patients who received a pretreatment multiparametric MRI according to a standardized protocol
- •Histopathologically proven SCC in the HN region (affected group)
- •Histopathologically proven Whartin tumour or pleomorphic adenoma in the HN region without malignant transformation (control group)
- •Patients in whom a or multiple clearly distinguishable cervical lymph node(s) can be observed radiologically, and which can be correlated unambiguously with the pathology report
排除标准
- •not fulfilling abovementioned criteria
- •thyroid or skin cancer
- •considerable artefact on MRI
- •previously surgery, irradiation or chemotherapy in the HN region
结局指标
主要结局
discriminatory value of MRI D value between tumoural and non-tumoural cervical lymph nodes
时间窗: preoperative
MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI perfusion curve between tumoural and non-tumoural cervical lymph nodes
时间窗: preoperative
MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
discriminatory value of MRI ADC value between tumoural and non-tumoural cervical lymph nodes
时间窗: preoperative
MRI parameters will be considered validated if they enable differentiation between a metastatic cervical lymph node and a non-tumoural lymph node, as based on the final pathology report as the 'gold standard'
次要结局
- discriminatory value of perfusion curve between bone invasion and no bone invasion(preoperative)
- discriminatory value of predefined perfusion curve between post-therapeutic sequelae and tumour relapse(follow-up until 5 years postoperative)
- predictive value of the MRI parameter Ktrans for treatment outcome(end of adjuvant radiochemotherapy (approx 10 weeks postoperative))
- predictive value of predefined Ktrans for overall and disease-free survival(postoperative follow-up at 3, 6, 12, 24, 36,48 and 60 months)
研究者
Johan Abeloos
head of department
AZ Sint-Jan AV