Initial Assessment of 18FDG-PET/MRI in Determining the Extent of Systemic Disease in Breast Cancer Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of metastatic lesions seen on PET/MRI as compared with PET/CT
研究概览
简要总结
Because MRI can provide increased brain and liver lesion detection as compared with CT, the investigators hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.
详细描述
This study is an initial assessment of the ability of 18FDG-PET/MR imaging to detect systemic disease in breast cancer patients as compared with conventional 18FDG-PET/CT.
Rationale: Accurate assessment of the extent systemic disease in breast cancer patients both initially and throughout treatment and surveillance comprises the basis for clinical care including surgical planning, radiation and drug selection. Shortcomings in FDG-PET/CT, a common current method of disease detection and surveillance, include decreased sensitivity in brain, liver and bone and a relatively high radiation dose, which could cause up to 5 new cancers per 1,000 patients (young American women) per scan. Initial studies assessing whole body MRI, a technique which involves no radiation, in the staging of breast cancer patients show promise, but can suffer from decreased ability to detect nodal disease and from detection of false positive lesions. Manual fusion of PET and MRI data in bowel and breast organ systems has been shown to decrease false positive lesions as compared with MRI alone. In the past year, molecular MRI imaging machines which combine PET and MRI imaging have become available for research purposes.
Hypothesis 1: We therefore hypothesize that FDG-PET/MRI will provide concordant or improved lesion detection as compared with FDG-PET/CT in breast cancer patients at a decreased radiation dose.
Hypothesis 2: In addition, the simultaneously acquired PET and MRI data allows for analysis of local tumor characteristics including perfusion, cellularity and glucose metabolism. In the subgroup of patients with an index breast cancer, we hypothesize that these local tumor metrics correlate with number and sites of systemic lesions.
Methods: All newly diagnosed breast cancer patients who are undergoing imaging evaluation for initial extent of disease or disease surveillance at NYU Cancer Center and Bellevue hospital are candidates for study in this protocol. Patients will be invited for follow-up FDG-PET/MRI imaging at any time they are undergoing FDG-PET/CT as part of their clinical care.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient with a history or breast cancer undergoing PET/CT either for initial staging or for disease surveillance
排除标准
- •Pregnant patients and patients with known contraindications for whole body MR imaging (e.g., pacemakers, recent surgery, brain vascular clips, etc.) will be excluded from the study. Patients will be screened with a questionnaire to be sure they have no medical devices that could make the procedure unsafe. Patients with glomerular filtration rate (GFR) < 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study.
结局指标
主要结局
Number of metastatic lesions seen on PET/MRI as compared with PET/CT
时间窗: 1 year
次要结局
- Patient stage as imaged by PET/MRI as compared with PET/CT(1 year)