Image-Guided Adaptive Radiotherapy for Head And Neck Cancer: Patient Image Acquisition
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%
研究概览
简要总结
This clinical trial studies image-guided adaptive radiotherapy in detecting tumors during treatment in patients with head and neck cancer. Image-guided adaptive radiotherapy uses high quality imaging technology to detect the tumor and normal organs during treatment. It is not yet known which imaging technique provides the best image for guidance during treatment with radiation therapy. Comparing results of imaging procedures done before, during, and after radiotherapy may help doctors plan the best treatment.
详细描述
I. To conduct a clinical imaging study utilizing three novel in-room imaging systems: Oblique Brainlab ExacTrac images, Orthogonal Varian kilovoltage (kV) On-board Imaging (OBI) image, and Varian cone-beam computed tomography (CBCT) imaging to assess their performance in reducing inter- and intrafractional setup errors, relative to weekly megavoltage (MV) electronic portal imaging device (EPID) images, using both bony landmarks and soft tissue changes for head and neck cancer (HNC) patients undergoing external beam radiation therapy (RT).
II. To assess the accuracy of CBCT imaging for measuring systematic soft tissue changes in the head and neck (HN) area relative to conventional high resolution contrast enhanced fan-beam computed tomography (CT) (FBCT) as a standard.
III. To assess the systematic and random soft tissue motion errors using daily CBCT imaging relative to bony-landmark alignment to evaluate the benefit of soft tissue imaging during radiotherapy.
IV. To quantify soft tissue changes during an entire course of radiotherapy (e.g. tumor shrinkage) using daily CBCT imaging.
V. To determine the feasibility of using measured set up and soft-tissue motion uncertainties in conjunction with volume changes observed on serial CBCT images, for offline adaptive replanning of HNC patients using available planning tools.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic or cytologic confirmation of head and neck malignancy
- •Patients who will be treated with definitive radiation therapy or concurrent chemoradiation therapy
- •Gross tumor volume (GTV) must be visible on CT
- •All patients must be informed of the investigational nature of this study and must give written informed consent in accordance with institutional and federal guidelines
排除标准
- •Pregnant or nursing women may not participate; women of reproductive potential must be offered a pre-treatment pregnancy test and informed of the need to practice an effective contraceptive method
- •Prior treatment with radiation therapy to the head and neck
- •Serum creatinine > 1.5 and/or
- •Blood urea nitrogen [BUN] > 25
- •Treatment with any prior chemotherapy or surgery (excluding diagnostic biopsy) for this malignancy
- •Patients with known syndromes expected to alter radiosensitivity (e.g. ataxia-telangiectasia, scleroderma, lupus, human immunodeficiency virus [HIV]/acquired immunodeficiency deficiency syndrome [AIDS]) may not participate
结局指标
主要结局
Dose Variation Between the Different Imaging Technologies for Normal Tissue Structures of 10%
时间窗: Up to 7 weeks
Differences of Calculated Set up Errors of 2 mm Between the Different Imaging Technologies
时间窗: up to 7 weeks
The automated patient setup procedure varies between 'OBI', 'CBCT' or 'Exactrac' imaging technologies. Each procedure gives two shifts: 'vertical' and 'lateral'. In the absence of a gold standard, our goal is to compare the shifts recommended by each pair of automated patient setup procedures. Average and Std deviation of vertical and lateral motion from the three systems were computed. P value, 1.00, refers to the test of difference of each system with OBI being more than 2 mm. Pairwise comparison for each direction between each pair of technologies were done using a t test to check if the difference in the recommended shift is more than 2 mm. The reported mean value represents the shift from planned treatment position averaged over all daily treatment setups. A negative mean vertical value indicates the patient was consistently set up posterior to plan; a negative mean lateral value indicates a set up consistently right of plan.
Greater Than or Equal to 5% Variation of Normal Tissue Toxicity
时间窗: Up to 7 weeks
次要结局
未报告次要终点