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临床试验/NCT01339780
NCT01339780已完成不适用

Imaging of Prostate and Breast Cancer Bone Metastases Using Magnetic Resonance Imaging and Nuclear Medicine Techniques

Turku University Hospital2 个研究点 分布在 1 个国家目标入组 53 人开始时间: 2011年2月最近更新:
适应症

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

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

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Marko Seppanen

Dr.

Turku University Hospital

研究点 (2)

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