DRKS00022464招募中1 期
A phase 1/2, open-label study to assess safety, tolerability, biodistribution, radiation dosimetry and PET imaging characteristics of [18F]FPyGal in comparison to in vitro diagnostic for the assessment of senescence in oncological patients - SenPET
niversitätsklinikum Tübingen0 个研究点目标入组 40 人开始时间: 2020年7月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomized controlled study
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 100 Years（—）
- 性别
- All
入选标准
- •All healthy volunteers must meet all the following criteria:
- •Male subjects = 25 to = 55 years of age;
- •Good general physical and mental health as determined by medical history, physical examination, 12-lead ECG, vital signs, and clinical laboratory tests, showing normal results.
- •Body mass index = 18.0 to = 30.0 kg/m2 and a body weight of at least 50 kg
- •Understand and voluntarily sign an informed consent document;
- •Able to adhere to the study visit schedule and other protocol requirements
- •Consent to practice double-barrier contraception until end of the study (28 days after [18F]FPyGal injection)
- •All patients must meet all the following criteria:
- •Male or female patients = 18 years of age;
- •Patients with locally advanced primary non-operable solid tumors (AEGs, rectum cancers, NSCLCs, NUT midline carcinomas (NMC))
- •ECOG Status = 2
- •Adequate bone marrow, renal, and hepatic function defined by laboratory tests within 14 days prior to study treatment
- •Patients scheduled for neo-adjuvant (radio-)chemotherapy and subsequent tumor surgery or tumor biopsy
- •Understand and voluntarily sign an informed consent document;
- •Able to adhere to the study visit schedule and other protocol requirements;
- •Consent to practice double-barrier contraception until end of the study (28 days after last [18F]FPyGal injection)
- •- Females of childbearing potential (FCBP) must agree:
- •o to use two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after end of study treatment and must agree to pregnancy testing during this timeframe;
- •o to abstain from breastfeeding during study participation and 7 days after end of study drug administration;
- •- Males must agree:
- •o to use a latex condom during any sexual contact with FCBP while participating in the study and for at least 28 days after end of study treatment, even if he has undergone a successful vasectomy;
- •o to refrain from donating semen or sperm while participating in the study and for at least 28 days after end of study treatment.
排除标准
- •Healthy volunteers will be excluded if one or more of the following criteria are met:
- •Presence of any current chronic or acute disease;
- •Need for permanent or acute medication;
- •Presence of relevant allergies in the history;
- •Intention or plan to donate sperm while participating in the study and for at least 28 days after end of study treatment;
- •Any contraindication to imaging procedures (e.g. CT);
- •Known hypersensitivity to [18F]FPyGal or its components or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product;
- •Subjects who refuse being informed on incidental findings in the imaging;
- •Previous exposure to ionizing radiation or radioactive substances as a result of clinical research or treatment within the past 10 years;
- •Positive alcohol/drug tests at screening, or at baseline (pre-dose) and/or not willing or able to refrain from drugs/alcohol during the study;
- •Donation or reception of blood or blood products within 1 month before Day 1 and until the end of the study;
- •Subject not able to declare meaningful informed consent on their own;
- •Participation in other clinical trials within 30 days before Day 1 until EOS or observation period of competing trials;
- •Male subjects with female partners of childbearing potential, unless willing to practice full and true sexual abstinence, or being surgically/permanently sterile, not willing to practice effective contraception by using a double-barrier method from Day 0 until 28 days post-dose.
- •Patients will be excluded if one or more of the following criteria are met:
- •Any contraindication for MRI (impaired renal function and / or known hypersensitivity to gadolinium-containing contrast agent are not considered as contraindication, since then imaging will be performed without gadolinium contrast agent);
- •Known hypersensitivity to [18F]FPyGal or its components or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product;
- •Administration of any kind of PET tracer within a period corresponding to 8 half-lives of the representative radionuclide (e.g. for fluorine-18: 109.77 min, 8x109.77 min =14.7 h);
- •Persistent toxicity (>Grade 2) according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, caused by previous cancer therapy, excluding alopecia;
- •Clinical signs of active infection (> Grade 2 according to CTCAE version 5.0);
- •History of HIV infection;
- •Immunocompromised patients;
- •Active or chronic viral hepatitis (HBV or HCV);
- •History of autoimmune disease;
- •History of relevant CNS pathology or current relevant CNS pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe brain injuries, dementia, Parkinson’s disease, cerebellar disease, organic brain syndrome, psychosis, coordination or movement disorder), Epilepsy requiring pharmacologic treatment;
- •Therapeutic anticoagulation therapy;
- •Major surgery within 4 weeks of starting study treatment;
- •Patients receiving any systemic chemotherapy or radiotherapy within 2 weeks prior to study treatment or a longer period depending on the defined characteristics of the agents used;
- •Heart failure NYHA III/IV;
- •Severe obstructive or restrictive ventilation disorder;
- •Known history of GI-perforation;
- •Patients not able to declare meaningful informed consent on their own;
研究者
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