NCT01751516已完成不适用
PET/MRI as a Predictor for Response to Preoperative Radiation Therapy and Chemotherapy in Resectable Rectal Cancer: a Pilot Study.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
研究概览
简要总结
This is a single arm, single center pilot study of 40 patients with uT3N0 or uT1-3N+ rectal cancer receiving pre-operative chemoradiation. Subjects will undergo PET/MRI scans before and after surgery.
详细描述
The primary purpose of this study is to determine the negative predictive value of PET/MRI for determining pathological complete response from neoadjuvant chemoradiation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •Low-lying, low- to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+
- •Negative workup for distant disease
- •> 18 years of age
- •Pre-treatment workup completed including:
- •history and physical
- •CT or MRI of the abdomen and pelvis
- •endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function)
- •if female of child-bearing age, negative pregnancy test
- •Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician
- •Informed consent reviewed and signed
排除标准
- •Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease
- •Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels)
- •ANC ≤ 1,500/cubic mm³
- •Platelet count ≤ 100,000/mm³
- •ALT and AST ≥ 2.5 times upper level of normal (ULN)
- •Alkaline phosphatase ≥ 2.5 times ULN
- •Total bilirubin ≥ 1.5 times ULN
- •Creatinine clearance < 50 mL/min
- •Creatinine ≥ 1.5 times ULN
- •Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness
- •Not deemed a surgical candidate
- •Currently active second malignancy, except non-melanoma skin cancer, non-invasive bladder cancer, low risk adenocarcinoma of the prostate and carcinoma in situ of the cervix
- •Previous pelvic radiation therapy
- •History of severe reaction to gadolinium
- •Inability to tolerate MRI (e.g., inability to lie flat for > 1 hour)
- •Presence of a pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes
- •Body Mass Index (BMI) > 35
- •Pregnant or lactating female
结局指标
主要结局
Negative post-chemoradiation PET/MRI scan, as correlated with surgical pathology
时间窗: 4-8 weeks post-chemoradiation
次要结局
- Overall survival(5 years)
- Recurrence-free survival(5 years)
- Disease-specific survival(5 years)
研究者
研究点 (1)
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