Pilot Study of Gene Expression and FDG-PET/MR Biomarkers for Evaluation of Response to Neoadjuvant Therapy for Locally Advanced Rectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 2
- 主要终点
- Change in FDG-PET/MR SUVmax
研究概览
简要总结
This pilot clinical trial studies gene expression analysis and fludeoxyglucose F 18 (FDG) positron emission tomography (PET)/magnetic resonance imaging (MRI) in evaluating treatment response in patients with rectal cancer that has spread to nearby tissue or lymph nodes undergoing chemotherapy and radiation therapy before surgery. Studying samples of tissue in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and may also help doctors predict a patient's response to treatment before surgery. PET-MRI is a procedure that combines the pictures from a PET scan and an MRI scan. The combined scans give more detailed pictures of areas inside the body than either scan gives by itself. PET-MRI may help determine how well people respond to pre-surgery chemotherapy and radiation therapy and help the surgeon make the best plan for removal of the tumor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Biopsy-proven adenocarcinoma of the rectum.
- •Surgical candidate.
- •Candidate for neoadjuvant chemotherapy.
- •Clinical evidence of T1-3N1 or T3N0 disease. This can be either by imaging studies or by physical exam findings.
- •At least 18 years of age.
- •Zubrod performance status of 0-
- •Able to understand and willing to sign a written informed consent document.
- •Patients with distant metastatic disease will be eligible if they satisfy all other conditions.
排除标准
- •Pregnant.
- •Past history of pelvic radiotherapy.
- •Received prior chemotherapy for colorectal cancer.
- •Uncontrolled diabetes with a fasting glucose ≥ 200 mg/dl at the time of PET/MRI imaging.
- •Claustrophobia or any other contraindication to MRI imaging evaluated by a standardized safety questionnaire.
- •Renal insufficiency (defined as glomerular filtration rate (GFR < 30 mL/min/1.73 m2) measured no more than 60 days before the first research scan) which precludes safe administration of the contrast agent.
- •Currently on dialysis.
- •Known prior allergic reaction to gadolinium-based MR contrast agents.
结局指标
主要结局
Change in FDG-PET/MR SUVmax
时间窗: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in ADCmean
时间窗: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Change in FDG-PET/MR SUVmean
时间窗: Baseline to up to 2 weeks before surgery
Images will be evaluated semi-quantitatively. Changes in imaging parameters will be correlated with pathologic response.
Radiosensitivity index
时间窗: Baseline
Index is calculated based on tumor gene expression. Will be correlated with the descriptive changes in FDG-PET/MR SUV and ADC parameters.
次要结局
未报告次要终点