EUCTR2017-000940-17-IT进行中（未招募）1 期
Phase IIa clinical study of 64 CuCl2: efficacy and safety of a new tracer for urologic tumors
未提供0 个研究点目标入组 20 人开始时间: 2018年1月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 20
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. Over 18 y/o patients at enrolling;
- •2. Patient afflicted with kidney, bladder or penis neoplasm elegible for demolitive surgery;
- •3. Histologically documented prostate cancer afflicted patients, in treatment with ADT (orchiectomy and/or LHRH agonists and/or androgen antagonists); patients with diagnosis of metastatic prostate cancer, detectable at re-staging TC scan too; recent disease progression (serial PSA increasing and/or clinical or radiological progression), under ADT, with clinical indication to restaging, even radiological.
- •4. Availability of a re-staging whole body CT scan (with and without contrast media) executed in 20 days prior to the enrollement (slice thickness < 5mm);
- •5. Availability of:
- •- re-staging whole body CT scan (with and without contrast media) executed 8 months prior to the enrollement visit (slice thickness < 5mm);
- •- At least one of the following functional and metabolism imaging exams, executed as clinically indicated restaging, 20 days prior to the enrollement:
- •?MRI (ossea),
- •?18F-FCH PET/CT,
- •?99mTc-HDP (SPECT)
- •?18F-FDG PET/CT;
- •6. No clinical history of other neoplasms (previously or at time of the enrollement), execpt non-melanoma skin carcinomas.
- •7. Karnofski index >80%
- •8. Absence of relevant comorbidities
- •9. Plain fitness to plead all the informations given in the Subject Illustration Documentation.
- •10. Plain fitness to subscribe an effective informd consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Anemia (Hb<10 g/dL)
- •2.Presence of symptoms or signs of sepsis and/or acute infections
- •3.AST more than 1.5 times higher than normality range limit
- •4.ALT more than 1.5 times higher than normality range limit
- •5.total bilirubin more than 1.5 times higher than normality rage limit
- •6.Clinical History or analytic evidence of HBV infection
- •7.Clinical History or analytic evidence of HCV infection
- •8.KCD more severe than stage II (eGRF< 60 ml/min calculated with MDRD equation)
- •9.TIA or Ictus less than six months before enrollement
- •10.Diagnosis of neurodegenerative disease
- •11.Other chronic CNS diseases
- •12.Clinical history of psychiatric pathology or therapeutical usage of major psychopharmacological drugs
- •13.ACS less than six months before enrollement
- •14.heart failure NYHA>1 or LVEF< 50%, clinically documentable
- •15.Valvulopathy with indication to surgical correction
- •16.Chronic respiratory disease with significative functional limitiation
- •17.Cupper metabolism diseases
- •18.Diabetes Mellitus under insuline therapy
- •19.Subjects who have received Chemiotherapics
- •20.Subjects underwent radiotherapy in the 120 days before enrolling
- •21.Subjects underwent major srgery interventions in the 120 days before enrolling
- •22.BMI> 28
- •23.Previous partecipation to clinical trials involving exposure to ionizing radiations with therapeutical purposes.
- •24.Work related exposure to ionising radiations
- •25.Any material, logistical or subjective condition that, even in the opinion of the principle experimenter, could condition subject’s compliance to execution of any of the procedures expected by the protocol
- •26.Subject’s inhability to understand informative documentation content.
- •27.Pregnancy -? Mandatory negative pregnancy test for women in fertile age.
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