EUCTR2014-001158-41-IT进行中（未招募）1 期
Technical and diagnostic performances of PET/CT with 64Cu(II)Cl2 in localization of metastases from prostate carcinoma, in patients undergoing restaging for disease progression during ADT” - PET/CT with 64Cu(II)Cl2 for prostate carcinoma
SPARKLE SR0 个研究点目标入组 50 人开始时间: 2018年1月2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
- 入组人数
- 50
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
- •1.age>=50 years at the time of enrollment (There is no upper age limit that contraindicate the diagnostic test)
- •2.documented previous histological diagnosis of primitive prostate adenocarcinoma
- •3.subject treated with ADT (orchiectomy, and/or LHRH agonists, and/or androgens antagonists)
- •4.previous clinical diagnosis of metastatic disease on bone, and/or lung, and/or lymphnode due to PCa (with involvement of pelvic region, and/or lumbar lymph node and/or sub phrenic), also documented with the restaging CT (See below)
- •5.recent disease progression (increase of PSA in serial determinations, and/or clinical progression and/or radiological), during ADT with clinical indication to restaging (also radiological)
- •6.availability of a Whole-body CT examination (with and without contrast medium), performed for restaging during the 20 days before the enrollment visit (slice thickness <5mm)
- •7.availability:
- •oa whole-body CT examination (with and without contrast medium), performed within the eight months before the enrollment visit (technically comparable whit the examination of restaging, particularly with slice thickness <5mm)
- •oat least one of the following imaging tests relative to functional metabolic, performed for restaging on BSE clinically indicated, within 20 days prior to enrollment visit:
- •MRI (bone), 18F-FCH PET / CT,
- •8.negative clinical history for other past or in progress neoplastic diseases, with the exception of non-melanoma skin cancers
- •9.Karnofski index >80%
- •10.the absence of other significant co-morbidities (see: Exclusion criteria)
- •11.complete ability to understand the information reported in the trial informative leaflet for the subject
- •12.complete ability to sign the valid informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 1
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •1.Anemia with Hb<10 gr/dL
- •2.Presence of symptoms or signs of sepsis and/or evidence of acute infection
- •3.AST >1.5 times the upper limit of the normal range
- •4.ALT >1.5 times the upper limit of the normal range
- •5.Total Bilirubin > 1.5 times the upper limit of the normal range
- •6.Clinical history and/or history of serological evidence for HBV infection
- •7.Clinical history and / or history of serological evidence for HCV infection
- •8.IRC more serious of stage II (GFR <60 ml/min calculated with MDRD equation)
- •9.TIA and stroke in the previous six months
- •10.Diagnosis of degenerative neurological disorder
- •11.Other chronic diseases of snc
- •12.Clinical history of psychiatric illness or use of psychotrope drug
- •13.Acute coronary syndrome in the previous six months
- •14.Heart failure with NYHA class> 1, or FE VS <50%, clinically documented
- •15.Valvular cardiopathy with indication for surgical correction
- •16.Chronic respiratory pathology with significant functional limitation
- •17.Diseases of copper metabolism (m.di Menkes, m.di Wilson)
- •18.Diabetes mellitus treated with insulin
- •19.Subjects treated with chemotherapy
- •20.Radiation therapy performed within the previous 120 days
- •21.Major surgery performed within the previous 120 days
- •22.BMI > 28
- •23.Previous participation in clinical trials with exposure to ionizing radiation for medical purposes
- •24.Occupational exposure to ionizing radiation
- •25.Any condition, material, logistical, or subjective, which, even in the opinion of the Principal Investigator, may affect the compliance of the subject to the execution of procedure provided in the Protocol
- •26.Inability to understand the information reported in the trial informative leaflet for the subject
研究者
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