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临床试验/NCT00288821
NCT00288821已完成不适用

The Diagnostic Accuracy of Non-invasive Lymph Node Imaging in Gynaecologic Malignancies

UMC Utrecht1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2006年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
UMC Utrecht
入组人数
84
试验地点
1

研究概览

简要总结

The purpose of the study is to determine the diagnostic accuracy of a new magnetic resonance imaging (MRI) technique, the diffusion weighted imaging with body background signal suppression (DWIBS) in the detection of lymph node pathology in patients with gynaecologic malignancies.

详细描述

The presence of lymph node metastases indicates a poor prognosis, with a marked decrease in 5-year survival rate. Lymph node involvement is an important factor in the choice of adjuvant treatment in gynaecological malignancies. Surgical lymphadenectomy is the gold standard for the diagnosis of lymph node metastases. This is a highly specialized procedure with increase in operative time and cost, and risk of surgery-related morbidity. Therefore, a non-invasive technique that accurately identifies lymph node metastasis would be beneficial. Diffusion Weighted whole body Imaging with Background Signal suppression (DWIBS) is a new imaging technique, which lightens lymph nodes and possibly differentiates normal and hyperplastic from metastatic lymph nodes. Cancer metastases in lymph nodes may be associated with alterations in water diffusivity and microcirculation within the node. It is also likely that cell density might play an important role. So far, no feasibility studies have will be evaluated for its accuracy, effectiveness, and feasibility in detecting lymph node metastases in gynaecological malignancies, as a possible alternative for the surgical staging method. The accuracy of a pelvic lymph node dissection (reference test) will also be evaluated by performing a post-operative DWIBS scan.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Patients with
  • Cervical cancer stage Ia2-Ib, IIa
  • Endometrial cancer stage I (high risk), II
  • Ovarian cancer stage I, IIa-IIa
  • Vulvar cancer stage I, II
  • Age > 18 years
  • Karnofsky score > 70

排除标准

  • Eligible for the PORTEC II trial
  • Contra-indications to the MRI: surgical clips in the brain, a pacemaker and claustrophobia

研究者

发起方
UMC Utrecht
申办方类型
Other
责任方
Principal Investigator
主要研究者

W.M. Klerkx

MD PhD

UMC Utrecht

研究点 (1)

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