Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan
研究概览
简要总结
This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.
详细描述
This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.
- A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.
- CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).
- At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.
Patients will be reviewed in outpatient clinic:
- At baseline
- Every 12 weeks until week 96, with the results of their recent scans.
- As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.
At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Histological diagnosis of breast cancer
- •Single or multiple bone metastases (additional extraosseous or non-bony metastatic disease permitted)
- •Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
- •Aged 18 and over
- •Life expectancy of over 6 months
- •No current active malignancy other than breast cancer
排除标准
- •Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
- •Absolute contraindication to MRI studies, CT scans, bone scans or FDG-PET/CT
- •Pregnancy
- •Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient as part of the informed consent process.
研究组 & 干预措施
WB-MRI and CT Scan
CT scan (neck/thorax/abdomen/pelvis) and WB-MRI
干预措施: WB-MRI (Other)
结局指标
主要结局
Proportion of disease progression in bone metastasis identified by WB-MRI prior to CT scan
时间窗: 36 months
Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan
次要结局
未报告次要终点