Evaluation of Resectable Cervical Carcinoma With PET/MRI
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
研究概览
简要总结
This trial studies how well positron emission tomography/magnetic resonance imaging (PET/MRI) scan works in checking patients with stage IA1-IB3 cervical cancer that can be removed by surgery (resectable). PET/MRI scan may help doctors learn more about the spread of the disease.
详细描述
PRIMARY OBJECTIVE:
I. To assess depth of cervical invasion with positron emission tomography/magnetic resonance imaging (PET/MRI) in patients with cervical cancer in clinical Federation of Gynecology and Obstetrics (FIGO) staging undergoing evaluation for surgical resection and correlate with pathology.
SECONDARY OBJECTIVES:
I. To correlate lymph node involvement on PET/MRI with pathology. II. To assess the inter-observer variability in the interpretation of PET/MRI. III. To correlate the quantitative imaging parameters of the tumor, such as the volumetric size, blood oxygen level dependent (BOLD), intravoxel incoherent motion (IVIM) analysis, apparent diffusion coefficient (ADC), diffusion tensor imaging (DTI), dynamic contrast-enhanced (DCE), metabolic tumor volume (MTV), total lesion glycolysis (TLG), standardized uptake value (SUV) and the glucose metabolic rate (GMR) with lymphovascular space invasion (LVSI) and tumor grade on surgical pathology.
OUTLINE:
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
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with suspected clinical stage IA1-IB3 cervical cancer except patients with tumors > 4 cm
- •No contraindications to MRI
- •Patients undergoing surgical procedure at MD Anderson
- •Suspected cervical cancer
排除标准
- •Patients who have contraindication to MRI
- •Glomerular filtration rate (GFR) < 30
- •Pregnant patients
- •Patients with history of previous radiation
- •Patients with previous surgery for cervical cancer, unless residual tumor noted on physical exam
- •Patients with endometrial cancer extending to the cervix
- •Allergic reaction to gadolinium based contrast
- •Body weight of greater than 450 (181.4 kg)
- •Patients requiring general sedation
- •Extremely claustrophobic patients
研究组 & 干预措施
Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
干预措施: Gadobutrol (Drug)
Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
干预措施: Magnetic Resonance Imaging (Procedure)
Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
干预措施: Positron Emission Tomography (Procedure)
Diagnostic (PET/MRI)
Patients receive fludeoxyglucose F-18 and gadobutrol IV over 1 minute and undergo PET/MRI over 90-120 minutes.
干预措施: Fludeoxyglucose F-18 (Other)
结局指标
主要结局
Accuracy of diagnosing depth of invasion on positron emission tomography/magnetic resonance imaging (PET/MRI)
时间窗: 3 years
Both PET/MRI and pathology results will be dichotomized into binary outcomes and the accuracy of PET/MRI will assessed.
次要结局
- Quantitative imaging parameters of the tumor(3 years)
- Assessing the Lymph node involvement by PET/MRI(3 years)
- Inter-observer variability of PET/MR(3 years)