Serial Magnetic Resonance Imaging of Longitudinal Radiotherapy-Attributable Normal Tissue Injury
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 425
- 试验地点
- 2
- 主要终点
- Dose-response correlation between imaging biomarkers
研究概览
简要总结
This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).
详细描述
PRIMARY OBJECTIVES:
I. Demonstrate the feasibility of serial magnetic resonance (MR) imaging biomarkers for assessment of early, intermediate, and late radiotherapy-attributable physiologic alteration of tumor and normal tissues and the kinetics thereof.
II. Develop MR-biomarker inclusive predictive models for development of radiotherapy-attributable normal tissue injury.
III. Define dose-response relationships between imaging biomarkers and subsequent radiation-induced effects.
OUTLINE: Patients are assigned to 1 of 2 cohorts.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All Cohorts:
- •Patients older than 18 years of age
- •Patients with good performance status (ECOG score 0-2)
- •Patients willing to give written informed consent.
- •Cohort 1 (Individuals without ORN or MRONJ):
- •Patients with histologically proven malignant neoplasms of the oral cavity, oropharynx or skull base.
- •Patients currently dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
- •Cohort 2 (Individuals with ORN or MRONJ):
- •Patients with a clinical diagnosis of ORN or MRONJ following treatment for cancer
- •Patients previously dispositioned to treatment with radiotherapy and/or antiresorptive or antiangiogenic medication therapy
排除标准
- •Patients unable to tolerate DW-MRI or DCE-MRI or having an estimated GFR < 30ml/min/1.73m
- •Patients with contraindication to MRI (e.g. non-MRI compatible metallic implants)
研究组 & 干预措施
Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
干预措施: Contrast Agent (Other)
Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
干预措施: Quality-of-Life Assessment (Other)
Cohort I (MRI after radiation therapy)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, 3-5 weeks after starting standard of care radiation therapy, and then at 2 months, 6 months, 12 months, and 3 years after completing radiation therapy.
干预措施: Questionnaire Administration (Other)
Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
干预措施: Contrast Agent (Other)
Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
干预措施: Magnetic Resonance Imaging (Procedure)
Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
干预措施: Quality-of-Life Assessment (Other)
Cohort II (MRI after surgery)
Patients may receive a contrast agent IV and then undergo an MRI over 45-60 minutes at baseline, and at 5-10 weeks and 12 months after standard of care surgery.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Dose-response correlation between imaging biomarkers
时间窗: Up to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dose-dependent modulation.
Radiotherapy-attributable imaging for normal tissue injury
时间窗: Up to 1 year
Will correlate whether post-therapy alterations in the observed multi-parametric imaging features can be used as surrogate bio-markers of normal tissue injury
Dose-response correlation between subsequent radiation-induced effects
时间窗: Up to 1 year
Penalized spline mixed regression will be used to characterize the induced functional relationships between the delivered dose and imaging biomarkers identified at each imaging time point. Doses for which 95% confidence interval estimates of mean trajectory fail to overlap will characterize ranges that yield significantly different levels of dosedependent modulation
次要结局
未报告次要终点