NCT02233595终止不适用
Evaluation of Rectal Cancer Treatment Response Using PET/MRI
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- change in SUVmax
研究概览
简要总结
The investigators will be using the combination of FDG-PET and multiparametric MRI in pre- and post-adjuvant chemoradiation therapy in order to attempt to predict pathologic response on surgical resection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •A diagnosis of histopathologically confirmed rectal adenocarcinoma.
- •Locally advanced disease as determined by ERUS or pelvic MRI. Endoscopy reports should clearly state both the T and N stage.
- •Patients with cT2N1-3M0 or cT2-4NxM0 will be considered eligible for participation.
- •Ability to understand a written informed consent document and the willingness to sign it.
- •Tumor must be determined to be surgically resectable. Surgical resection is planned to take place at Univeristy of California, San Francisco (UCSF).
- •Neoadjuvant chemoradiation prior to resection is planned..
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2.
排除标准
- •ERUS tumor state of T
- •Radiographic evidence of metastatic disease
- •Weight in excess of limitations of the scanner or girth that prohibits entry into the bore of the PET/CT scanner due to size.
- •Any medical condition which impairs the ability to lie flat and without movement for 15 minutes (e.g. cough, severe arthritis, etc.)
- •Prior receipt of any therapy, including local excision, radiation or chemotherapy, for the diagnosed rectal adenocarcinoma.
- •Prior history of pelvic radiation.
- •Uncontrolled hyperglycemia (defined as inability to achieve a glucose of <250 mg/dL at time of fluorodeoxyglucose (FDG) injection).
- •Impaired renal function (CKD 4 or 5: estimated glomerular filtration rate (eGFR) < 30 mLs/min), which is a contraindication to gadolinium containing contrast.
- •Known allergy to gadolinium containing contrast agents.
- •Contraindication to use of fluoropyrimidines as a radiosensitizing agent.
- •Pregnancy or nursing. Women of child bearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to randomization. This is because of the potential teratogenic effects of the involved imaging modalities, radiation, and chemotherapy.
结局指标
主要结局
change in SUVmax
时间窗: 2 months
To determine whether percent change in SUVmax correlates with the extent of pathologic primary tumor response
tumor volume
时间窗: 2 months
To determine whether percent change in tumor volume correlates with the extent of pathologic primary tumor response
次要结局
未报告次要终点
研究者
研究点 (1)
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