EUCTR2020-002868-31-AT进行中（未招募）1 期
A Phase I/IIa study to evaluate safety, biodistribution, dosimetry and preliminary diagnostic performance of [68Ga]Ga-Deferoxamine for PET imaging in patients with bacterial infections
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 15
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
- All
入选标准
- •1Understanding and provision of signed and dated written informed consent by the patient or legally acceptable representative prior to any study-specific procedures.
- •2Age > 18 years.
- •3Patients with bacterial infections (e.g. Pseudomonas aeruginosa, Staphylococcus spp., Streptococcus spp., etc. of any region except the urinary tract) or patients with infections of implanted devices (e.g. orthopaedic or vascular implants, pacemakers, catheters, etc.).
- •4Strong clinical indication or confirmation of bacterial infection with typical alterations of laboratory markers (ESR, CRP, and/or leucocyte number). If microbiologically confirmed, the bacterial spectrum must be available. If not microbiologically confirmed, any available microbiology samples before antibiotic treatment should be stored for following studies on [68Ga]Ga-Deferoxamine uptake in vitro.
- •5Participating men must use a single barrier method for contraception for 1 month after completion of the trial starting at the day of application of [68Ga]Ga–Desferoxamine.
- •6Women of childbearing age must use two highly effective methods of contraception during the trial and 6 months after application of investigational product if not in menopause or after hysterectomy.
- •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 10
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 5
排除标准
- •1 Pregnancy; breast-feeding; females planning to bear a child recently or with childbearing potential, unless a commonly accepted effective means of contraception is used.
- •2Patients with cystic fibrosis (CF)
- •3Patients having a confirmed bacterial infection with a bacterial spectrum that is known to lack uptake of [68Ga]Ga-Deferoxamine (e.g. E.coli)
- •4 Patients under therapy with Deferoxamine (Desferal®) or other metal chelators.
- •5Patients with rheumatoid arthritis, connective tissue disorders and other conditions known to be associated with active chronic inflammation (e.g. Inflammatory Bowel Disease).
- •6Any other concurrent severe and/or uncontrolled and/or unstable medical condition that, in the opinion of the investigator, may significantly interfere with study compliance.
- •7Known or expected hypersensitivity to Ga-68 or Deferoxamine (Desferal®).
- •8Prior administration of a radiopharmaceutical for PET-imaging within a period corresponding to 8 half-lives of the radionuclide used on such radiopharmaceutical.
- •9Subjects with any kind of dependency on the investigator or are employed by the sponsor or investigator.
- •10Participation in any other investigational trial within 30 days of study entry with potential interactions regarding the study drugs or the underlying disease.
- •11History of somatic or psychiatric disease/condition that may interfere with the objectives and assessments of the study.
- •12Patients with iron overload disease.
- •13Patients with glomerular filtration rate below 30 ml/min/1,73 m2 where primarily renal excretion of Ga-68 or Deferoxamine could be impaired.
研究者
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