EUCTR2008-005219-16-GB进行中（未招募）1 期
A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET Imaging
GE Healthcare Ltd0 个研究点目标入组 30 人开始时间: 2010年10月11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
- 30
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
入选标准
- •- The subject has been diagnostically imaged and is suspected of having a primary or metastatic tumour lesion of one of the following types: high-grade glioma, including GBM, anaplastic astrocytoma, and anaplastic oligodendroglioma; lung cancer, including SCLC and NSCLC; H&N tumours, including laryngeal squamous cell carcinoma, and well-differentiated thyroid and oral cavity carcinoma; sarcoma; and melanoma; or having a primary or metastatic RCC tumour.
- •- The subject’s tumour is greater than or equal to 2.0cm in diameter except for thyroid carcinoma (greater than or equal to 1.5 cm).
- •- The chosen target tumour is not within the liver.
- •- The subject is scheduled to undergo resection or biopsy of the target tumour as a result of routine clinical treatment.
- •- The subject is scheduled to undergo or has received standard of care diagnostic imaging work-up (following the study centre’s routine procedures), e.g. CT with or without contrast, MRI with or without contrast, bone scintigraphy, X-ray, or FDG-PET.
- •- The subject has the following baseline laboratory parameters: blood urea nitrogen (BUN) value and serum creatinine (sCr) value of less than or equal to 1.5 of the upper normal limit; prothrombin time (PTT) and an activated partial thromboplastin time (aPTT) within normal limits; platelet count of greater than or equal to 150,000 x 10exp6/L; and haemoglobin value of greater than 9 g/dL.
- •- The subject has a clinically acceptable (as judged by the investigator) physical examination at screening and is capable of self-care, i.e. Eastern Cooperative Oncology Group (ECOG) performance status is 0 to 2, such that the subject has a high chance to complete the study.
- •- The subject has not received any anti-angiogenic agents (e.g. bevacuzimab, sorafenib, sunitinib) within 60 days prior to PET imaging.
- •- Female subjects need to be either surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), or if of childbearing potential the results of a serum pregnancy test performed within 24 hours must be negative and with the result known before administration of AH111585 (18F) Injection. Female subjects of reproductive potential should also employ an effective method of birth control. Barrier contraceptives must be used throughout the study in both sexes.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- The subject has received another investigational medicinal product (IMP) within 14 days before, or will receive an IMP within 1 week after administration of AH111585 (18F) Injection.
- •- The subject has any contraindication to any of the study procedures, products used or its constituents (e.g. X-ray contrast media).
- •- The subject has known hyper- or hypo-coagulation syndromes. Such coagulopathies include but are not limited to Von Willebrand disease, Protein C deficiency, Protein S deficiency, Hemophilia A/B/C, Factor V Leiden, and Bernard-Soulier syndrome.
- •- The subject has known diagnosis of human immunodeficiency virus (HIV) or hepatitis B or C infection.
- •- The subject is unable to lie down for 125 minutes.
- •- The subject is being treated with heparin or coumadin.
研究者
相似试验
进行中（未招募）
不适用
A Phase 2a, Open-label, Proof-of-Concept Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Intranasal Clonazepam in Adult Subjects with Epileptic SeizuresRecurrent Acute Repetitive Seizures (ARS)MedDRA version: 9.1Level: LLTClassification code 10039910Term: SeizuresEUCTR2007-003307-13-FIJazz Pharmaceuticals, Inc.45
已完成
2 期
A Phase 2a, Proof-of-Concept, Open-Label Study to Evaluate the Pharmacodynamics, Pharmacokinetics, and Safety of Obicetrapib in Patients with Early Alzheimer*s Disease (Hetero/Homozygote APOE4 Carriers)10057167dementiaAlzheimer's diseaseNL-OMON51159ewAmsterdam Pharma B.V.15
进行中（未招募）
1 期
A study to evaluate the effect and safety of obicetrapib in patients with early Alzheimer's disease (Hetero/Homozygote APOE4 carriers)Alzheimer's diseaseEUCTR2021-002687-41-NLewAmsterdam Pharma BV15
进行中（未招募）
1 期
A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsActive Skin Extra-Intestinal Manifestations in Inflammatory Bowel Disease.EUCTR2016-003797-40-DEArena Pharmaceuticals, Inc.20
进行中（未招募）
1 期
A clinical study to investigate the effectiveness and safety of treatment with the drug APD334 in ulcerative colitis and crohn's disease patients with skin conditionsEUCTR2016-003797-40-BEArena Pharmaceuticals, Inc.20