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临床试验/NCT02334371
NCT02334371已完成不适用

MR-PET for Staging and Assessment of Operability in Ovarian Cancer - a Feasibility Study

Maastricht University Medical Center2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2015年4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
10
试验地点
2
主要终点
Diagnostic performance

研究概览

简要总结

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer.

详细描述

Recently, the academic hospital Maastricht invested in an integrated MR-PET system (Biograph mMR, Siemens Healthcare, Erlangen, Germany), ready to use for routine clinical application. Applications of this system are numerous and various types of cancer, including ovarian cancer, could benefit from the possibilities. The whole-body MR-PET system integrates the strengths of MRI and PET within a single examination. MRI provides anatomic detail in staging local tumor extent due to its high soft tissue resolution and advanced functional techniques such as DWI further enhance both local and distant lesion detection and characterisation. PET imaging complements this structural and functional information with molecular imaging technology useful in staging of adenopathy and metastatic spread. These characteristics contribute to a wide spectrum of possible clinical oncological applications, from primary tumor detection to local and distant staging, selection of patients for neoadjuvant therapy and assessment of response to chemotherapy and finally evaluation of recurrent disease.

The importance of selecting patients with ovarian cancer who will benefit from either primary debulking surgery or neoadjuvant chemotherapy followed by interval debulking surgery has been acknowledged worldwide but the optimal diagnostic modality to serve in this matter remains to be discovered. We believe that combined magnetic resonance imaging and positron emission tomography (MR-PET) can be of great clinical value in preoperative staging of patients with ovarian cancer. Both positron emission tomography (PET), computed tomography (CT) and magnetic resonance imaging (MRI) have proved to be useful in ovarian cancer staging but understaging due to difficulties in depicting peritoneal dissemination remains a great problem. In conclusion, the best method for staging ovarian cancer and assessing operability remains to be discovered, hence this study.

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

入选标准

  • Expected FIGO stage IIB-IV epithelial ovarian carcinoma
  • Scheduled for primary debulking or interval debulking surgery
  • Written informed consent

排除标准

  • Patients estimated to have more benefit from chemotherapy
  • Ineligibility to undergo MR-PET examination (Non-MR compatible metallic implants or foreign bodies (ferromagnetic aneurysm clip, pacemaker, neurostimulation system, metal splinters etcetera) or claustrophobia)
  • Pregnant or lactating patients.
  • Incapacitated subjects

结局指标

主要结局

Diagnostic performance

时间窗: 6 months

Diagnostic performance of MR-PET compared to CT for characterisation of primary tumour, detection of tumour sites in the peritoneal cavity, retroperitoneum or liver, detection of lymphadenopathy and distant metastases and assessment of tumour stage and operability.

次要结局

未报告次要终点

研究者

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

Iris Rutten

Drs.

Maastricht University Medical Center

研究点 (2)

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