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临床试验/NCT01710085
NCT01710085Unknown不适用

Diagnostic Value of Diffusion Weighted Imaging in Detection of Recurrent Disease in Cervical and Endometrial Cancer Treated With Curative Surgery

Uludag University2 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2012年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

研究概览

简要总结

Endometrial and cervical cancers are one of the most common malignancies seen in females. Identification of recurrent disease in early phases of treatment carries a primary importance on the outcome of patients. Diffusion-weighted magnetic resonance imaging (DWI) is a new technique recently started to be performed in body imaging and has potential ability to detect recurrent disease. The aim of this study is to investigate the diagnostic impact of DWI in detection of recurrent disease in patients treated with curative surgery in endometrial and cervical cancer.

详细描述

Endometrial and cervical cancers are one of the most common malignancies seen in female genital tract. Although, surgical resection is the treatment of choice for both, adjuvant or neo-adjuvant chemotherapy or radiotherapy and curative radiotherapy are alternative treatment options depending on the stage.

Identification of recurrent disease in early phases carries a primary importance on the prognosis.

Diffusion-weighted MRI (DWI), a new technique recently started to be performed in body imaging has potential ability to distinguish recurrent disease from normal tissue or fibrosis. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

All patients who had curative surgery due to endometrial or cervical cancer will be included to the study. Patients will be examined with DWI in addition to routine sequences including contrast enhanced dynamic studies. The sensitivity, specificity, accuracy as well as positive and negative predictive values of the study will be investigated from the data derived from DWI studies and will be correlated with data obtained by conventional radiologic, nuclear imaging studies including PET-CT, as well as pathologic verifications during follow-up period.

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
Double (Investigator, Outcomes Assessor)

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

  • Pathologic diagnosis of cervical or endometrial cancer.
  • Patients treated with curative surgery (hysterectomy)will be involved on a voluntary basis.

排除标准

  • Contraindications for MRI examination (cardiac pacemakers, metallic objects, cochlear implants, claustrophobic patients)

研究组 & 干预措施

Diffusion weighted imaging, Recurrence

Experimental

干预措施: Diffusion weighted MRI (DW- MRI)- Philips Achieva 3.0T X, Netherlands, 2011 (Device)

结局指标

主要结局

Investigation of the diagnostic value of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

时间窗: 18 months

Postoperative recurrent disease is usually investigated with physical examination, ultrasonography, computed tomography (CT), conventional magnetic resonance imaging (MRI) and positron emission tomography-computed tomography (PET-CT) with different sensitivity and specificities. However, radiologists experience difficulty in detection of small recurrent active tumors with anatomically-based radiologic modalities like CT or conventional MRI in patients treated with hysterectomy. Furthermore, effects of adjuvant therapies or fibrosis developed following surgery could mask or even mimic the recurrent tumor. Our aim in this study is to investigate the diagnostic impact of DWI in detection of recurrence rate in patients treated with curative surgery in endometrial and cervical cancer.

次要结局

未报告次要终点

研究者

发起方
Uludag University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kadir Hacikurt

Dr. Kadir Hacıkurt

Uludag University

研究点 (2)

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