EUCTR2014-005345-50-CZ进行中（未招募）1 期
Diagnostic feasibility and morfological and functional correlation of PET examination in use of [18F]-Fluorocholin inj. in patients with prostate cancer - Fluoromethylcholinium-(18F)-chlorid inj.
Masarykuv onkologický ústav0 个研究点开始时间: 2015年3月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Male
入选标准
- •age = 18 years
- •clinically localized/locally progressed prostate cancer- high risk group (clinical stage cT2c or higher or PSA higher than 20 ng/ml or Gleason score more than 8-10) before the planned curative therapy to exclude a metastatic impairment
- •examination of the disseminated prostate cancer to assess the impaired area
- •biochemical recidive after a radical treatment od prostate cancer to localise the recidive and eventually to plan a targeted local therapy
- •signed informed consent
- •ECOG PS 0-1
- •Laboratory values:
- •bilirubin < 1,5x maximum normal value
- •creatinine < 1,5x maximum normal value
- •urea < 1,5x maximum normal value
- •trombocytes > 50 x 109 / l
- •diagnostic CT examination of abdomen and pelvis performed max. 28 days prior to study PET examination
- •assessment of PSA max. 14 days prior to study PET examination, in case of relaps of the disease - assessment of PSA doubling time
- •Aa least 3 weeks from eventual last application of anticancer treatment and 6 weeks from
- •eventual last radiotherapy (first 4 subjects should not by premedicated neither by chemotherapy nor by radiotherapy in order to restrict the possible infuence of those treatmensts on the quality of examinations)
- •ability to cooperate according to the requirements of protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 30
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •hypersensitivity to any compound of the investigational medicinal product
- •renal impairment
- •urea > 1,5x maximum normal value
- •creatinine > 1,5x maximum normal value
- •presence of any psychical, familial, social or geographic obstacles which could cause noncompliance with the protocol. These facts must be discussed with the subject prior to his/her inclusion
- •weight more than 204 kg or deformity of thorax that could make the passage of the gantry of the device (diameter 70 cm) impossible
- •claustrophobia or incapacity to lie 20 minutes without moving
研究者
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