Optimized Diffusion-Weighted Imaging for the Evaluation of Post-Treatment Squamous Cell Carcinoma in the Neck: Comparative Study With FDG PET/CT
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Apparent Diffusion Coefficient Mean (ADCmean)
研究概览
简要总结
The investigators propose a longitudinal study evaluating post-treatment changes in patients with squamous cell carcinoma (SCC) of the neck using an innovative optimized diffusion-weighted imaging (DWI) pulse sequence to identify more accurately recurrent tumors as well as early non-responders to therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
盲法说明
All anonymized MRI studies will be blindly evaluated by at least two experienced neuroradiologists
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
- •Histologically-proven newly diagnosis or recurrence as indicated by tissue diagnosis of T3 or T4 squamous cell carcinoma of the head and neck
- •Must have had or be scheduled for standard-of-care surgical resection, radiation, and/or chemo-radiation of the diagnosed squamous cell carcinoma of the head and neck
- •At least 18 years of age
- •Patient must be able to understand and willing to sign a written informed consent document.
排除标准
- •Contraindications to MRI, including:
- •MRI-incompatible implantable devices
- •severe claustrophobia; and
- •Pregnant and/or breastfeeding, with women of childbearing potential having a negative urine or serum pregnancy test
研究组 & 干预措施
DWI MRI + Standard of care FDG PET/CT
-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.
干预措施: Diffusion-weighted imaging magnetic resonance imaging (Device)
DWI MRI + Standard of care FDG PET/CT
-The patients will undergo an optimized research neck DWI MRI, up to 3 weeks post-treatment and then a standard-of-care 3-month post-treatment FDG PET/CT examination.
干预措施: FDG PET/CT (Device)
结局指标
主要结局
Apparent Diffusion Coefficient Mean (ADCmean)
时间窗: 2-3 weeks post-standard of care treatment
* ADC=measure of the magnitude of diffusion (of water molecules) within tissue * The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis * A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) * ADCmean will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
Apparent Diffusion Coefficient Lowest Value in a Tumor (ADCmin)
时间窗: 2-3 weeks post-standard of care treatment
* ADC=measure of the magnitude of diffusion (of water molecules) within tissue * The primary tumor, suspicious lesion, and/or area of post-treatment change will be identified in anatomical images \& then outlined in the ADC sequence, excluding areas of cystic change and necrosis. If there are multiple lesions, only the dominant lesion with the lowest ADC will be used for analysis * A histogram analysis method will examine the distribution of ADC values within each region of interest (ROI) * ADCmin will describe distribution of ADC measurements in tumor/non-tumor tissues \& independent sample t-test will compare ADC measurements between the 2 groups
次要结局
- Number of Participants That Were Non-responders to Treatment on Both the DWI MRI and the Standard of Care FDG PET/CT(2-3 weeks post-standard of care treatment)