跳至主要内容
临床试验/NCT03068403
NCT03068403终止不适用

Dynamic Contrast Enhanced Ultrasound for Predict and Assess Rectal Cancer Response After Neo-adjuvant Chemoradiation - RECT

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2018年6月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
终止
发起方
入组人数
2
试验地点
1
主要终点
Area under the echo-power curve (AUC)

研究概览

简要总结

In recent years the concept of organ sparing treatment in rectal cancer was introduced for selected good responders after neo-adjuvant treatment. In these patients replacement of the standard of care total mesorectal excision (TME) by transanal endoscopic microsurgery (TEM) or omission of surgery after chemoradiation (CRT) was proposed. Before organ sparing treatments could be applied in clinical practice a reliable patient selection procedure has to be available as only good treatment responders after neo-adjuvant therapy are candidates for such adapted therapy. Different imaging modalities have been studied for their ability to distinguish good treatment responders from others. Examples of such imaging modalities with some promising results regarding response assessment are fludeoxyglucosepositron emission tomography (FDG-PET), T2-weighted magnetic resonance imaging (T2w-MRI), dynamic contrast enhanced magnetic resonance imaging and diffusion weighted MR imaging (DW-MRI). Besides these modalities dynamic contrast enhanced ultrasound (D-CEUS) is a new modality used for tissue characterization and therapy response assessment in several tumor locations, like liver tumors and breast cancer. D-CEUS reflect tissue vascular perfusion. For rectal cancer, the value of D-CEUS for pathological response prediction and assessment has never been assessed. Therefore, in this study we assessed D-CEUS to predict and assess pathological response in rectal cancer after neo-adjuvant CRT.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Histologically confirmed rectal carcinoma
  • Stade ≥T2 and tumor size ≥3cm
  • No detectable metastases
  • Patient ≥ 18 years
  • Patient information and written informed consent form signed
  • Patient who can receive radiotherapy and chemotherapy
  • Negative pregnancy test in women of childbearing potential
  • Patient covered by a Social Security system

排除标准

  • Indication for immediate surgery
  • Primary tumor not measured at the MRI before inclusion
  • Previous pelvic radiotherapy
  • Contraindication to SONOVUE or MRI

研究组 & 干预措施

Radiochemotherapy

Other

干预措施: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration (Procedure)

Chemotherapy and Radiochemotherapy

Other

干预措施: Dynamic contrast enhanced ultrasound (D-CEUS) with Sonovue® administration (Procedure)

结局指标

主要结局

Area under the echo-power curve (AUC)

时间窗: At inclusion, 3 months and 6 months visits

次要结局

  • Rise time (RT)(At inclusion, 3 months and 6 months visits)
  • Peak enhancement (PE)(At inclusion, 3 months and 6 months visits)
  • mrTNM staging(At inclusion, 3 months and 6 months visits)
  • Wash-in area under the curve (WiAUC)(At inclusion, 3 months and 6 months visits)
  • Mean transit time (mTT)(At inclusion, 3 months and 6 months visits)
  • Time to peak (TTP)(At inclusion, 3 months and 6 months visits)
  • Whash-in rate (WiR)(At inclusion, 3 months and 6 months visits)
  • Wash out rate (WoR)(At inclusion, 3 months and 6 months visits)
  • MRI assessed Tumor Response Grade (mrTRG)(At inclusion, 3 months and 6 months visits)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验