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临床试验/NCT01621529
NCT01621529已完成不适用

Contribution of 18FDG PET-Scan in Tumour Volume Determination in Patients Operated of Breast Cancer

Centre Henri Becquerel1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2010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
30
试验地点
1

研究概览

简要总结

Use of positron emission tomography (PET) in determination of functional tumour volume can provide usable information for radiotherapy to define the irradiated volume.

To determine the best tumour volume measure method, the investigators have chosen as model the breast cancer which allows us to study a stationary or moving organ by the patient position and belonging to a primary surgery.

The used methodology is based on lesion volume measure in preoperative time, obtained with PET, and on the measure of specimen volume by the anatomic laboratory after surgery.

This study's main objective is to compare this two measure of tumour size and secondarily to compare TEP with or without respiratory gating.

The PET-scan is achieved with FDG, under his French permission marketing, and acquire in 3 times:

A whole body acquisition in supine position, follow by a centered tumour acquisition with respiratory gating, then an acquisition in prone position to immobilise the lesion.

This study is monocentric and descriptive. It provides to include 30 patients in 1 year.

详细描述

The use of positron emission tomography (PET) in determination of functional tumour volume may pose two major problems especially for the exact delineation of tumour contours:

  • Respiratory movements, when the tumour is thoracic, may induce an overestimation
  • The PET's low spatial resolution, linked to the emission of photons

The usual method to define tumour contours result of three types of delineation usually used: the visual contouring, the segmentation based on an activity threshold fixed, and the segmentation with adaptive thresholding.

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

  • Invasive non-lobular breast cancer, histologically proven by biopsy
  • Tumour T2 - T3 regardless of nodal status, stemming from a primary surgery, in whom FDG-PET is performed for staging
  • Age greater than or equal to 18 years
  • Good condition: WHO lower
  • Women receiving effective contraception throughout the duration of treatment and 3 months after cessation of treatment,
  • Patient has signed informed consent

排除标准

  • Carcinoma other than breast ductal carcinoma.
  • Patients for whom no target tumor is assessable.
  • Patients for whom surgery first of their breast cancer is not indicated (tumor spread, metastasis, general health, co-morbidities).
  • Pregnant women, or likely to be during breastfeeding.
  • Major protected (under supervision and under guardianship)
  • Failure to submit to medical supervision of the study for reasons of geography, social or psychological
  • Incomplete tumor resection

研究者

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

Pierre Vera

heads of nuclear medecine department

Centre Henri Becquerel

研究点 (1)

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