Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 53
- 试验地点
- 2
- 主要终点
- Number of participants with bone metastases
研究概览
简要总结
Prostate and breast cancer continues to be the most common cancer among men and women, respectively. The exact assessment of the cancer spread with detection of possible bone metastasis is crucial for treatment decision. In the current study 50 patients with prostate cancer and 50 patients with breast cancer at high risk for bone metastases or with know metastatic disease will be studied with multiple imaging modalities. Patients will be recruited from the Department of Oncology, Turku University Hospital. Planar bone scintigraphy (BS), single photon emission computed tomography combined with low-dose computed tomography (SPECT/CT), 18F-fluoride positron emission tomography computed tomography (PET/CT) and magnetic resonance imaging (MRI) will be performed to all patients. The primary objective is to determine the diagnostic accuracy of the four imaging modalities. The secondary goal is to calculate the sensitivities and specificities of the four imaging modalities on a patient-to-patient and lesion-to-lesion basis. Based on the results of this study an optimal imaging protocol for detection of prostate and breast cancer bone metastasis will be developed and validated.
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
- 40 Years 至 80 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40 to 80 years
- •Language spoken: Finnish or Swedish
- •Performance status: Karnofsky score 70 or better or WHO performance status 2 or better
- •Diagnosis: Histologically confirmed prostate or breast cancer
- •Mental status: Patients must be able to understand the meaning of the study
- •Informed consent: The patient must sign the appropriate Ethics Committee (EC) approved informed consent documents in the presence of the designated staff
- •strong suspicion of first bone metastatic disease (already diagnosed metastases in other organs, elevated tumor markers, destruction of bone in plain x-ray or otherwise specified reasons
- •adjuvant chemo- or endocrine therapy is allowed
排除标准
- •Ongoing treatment for metastatic disease
- •Contraindications for MRI (cardiac pacemaker, intracranial clips etc.)
- •Infections: Patient must not have an uncontrolled serious infection
- •Claustrophobia
结局指标
主要结局
Number of participants with bone metastases
时间窗: at least 6 months follow up
次要结局
未报告次要终点
研究者
Marko Seppanen
Dr.
Turku University Hospital
