LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
研究概览
简要总结
This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.
详细描述
This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of [18F] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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
- •≥ 18 years of age (no upper age limit)
- •Informed consent obtained and signed
- •cT2/T3-N0-M0 urothelial carcinoma of the bladder
- •Planned radical cystectomy with pelvic lymph node dissection
- •No known local regional or distant metastatic disease
- •Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI
排除标准
- •History of severe reaction to contrast-enhanced CT scan
- •Poorly controlled diabetes mellitus
- •Inability to tolerate PET and/or MRI
- •Presence of pacemaker or intracranial aneurysm clip
- •Serum creatinine >1.8 mg/dL OR GFR < 30mL/min
- •Pregnant or lactating female
- •Inability to lie flat for >1 hour
- •Body Mass Index (BMI) >35
- •History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer.
- •Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
研究组 & 干预措施
FDG PET/MR, No Chemotherapy Arm
Patients that are NOT receiving chemotherapy but are only completing surgical intervention.
干预措施: FDG PET/MR (Procedure)
FDG PET/MR, Chemotherapy Arm
Patients that are receiving chemotherapy prior to completing surgical intervention. These patients will receive a FDG PET/MR prior to chemotherapy and after completion of chemotherapy (at the time of pre-op, before surgical intervention).
干预措施: FDG PET/MR (Procedure)
结局指标
主要结局
Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
时间窗: 3 years
The sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder will be evaluated by using the pathology from the radical cystectomy and lymph node dissection specimen or biopsy as the reference standard. The sensitivity and specificity of FDG-PET-MRI will be compared to conventional CT performed in all patients in this pilot study and FDG-PET-CT.
次要结局
- Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer(3 years)