EUCTR2018-003229-27-NO进行中（未招募）1 期
ImPRESS - Imaging Perfusion Restrictions from Extracellular Solid Stress - An open-label losartan study - ImPRESS
Oslo University Hospital0 个研究点目标入组 165 人开始时间: 2019年2月26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）
- 发起方
- 入组人数
- 165
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
- •1. A histologically confirmed intracranial glioblastoma, WHO grade 4 (Study A), or a minimum of one radiographically confirmed metastasis to the brain from a primary non-small-cell lung cancer (Study B)
- •2. Ability to undergo an MRI exam, including administration of a standard clinical dose of an MRI-specific contrast agent of gadolinium or similar
- •3. Measurable intracranial disease (Study A – recurrent glioblastoma, and Study B only), defined as at least one lesion that can be accurately measured in at least one dimension as =5 mm with MRI – or – compromise more than 30 image voxels on perfusion MRI to ensure adequate parametric statistical assessments. For a perfusion MRI resolution of 1.2x1.2x5mm, this equals a tumor volume of 0.2 cubic centimeters (cc).
- •4. Age =18 years
- •5. Eligible for administration of the active substance (losartan) in concordance with study protocol, the criteria of the product label (Cozaar) and deemed fit for trial by the treating physician.
- •6. An ECOG performance status of =2 or equivalent KPS of =60%
- •7. Life expectancy from start of treatment of more than 3 months
- •8. Deemed eligible for neurosurgery (Study A – newly diagnosed glioblastoma) or stereotactic radiosurgery (Study B) by the treating physician
- •9. Scheduled for chemotherapy (Study A – recurrent glioblastoma), neurosurgery, radiotherapy and chemotherapy (Study A – newly diagnosed glioblastoma), immunotherapy and/or chemotherapy (Study B)
- •10. Pre-study documentation on O6-methylguanin-DNA-methyltransferase (MGMT) promoter methylation status and on the isocitrate dehydrogenase (IDH) gene mutation status of their disease (study A only)
- •11. Organ functions of sufficient quality and robustness to undergo study treatment as determined by the study principal investigator (PI) or designee
- •12. Female patients of childbearing potential (postmenarcheal, not postmenopausal (>12 continuous months of amenorrhea with no identified cause other than menopause), and no surgical sterilization) should use highly effective contraception and take active measures to avoid pregnancy while undergoing IMP treatment and for at least 14 days after the last dose. Birth control methods considered to be highly effective include combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal or transdermal), progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable or implantable), intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner, sexual abstinence when it is the preferred and usual lifestyle of the subject.
- •13. Ability to understand and the willingness to sign a written informed consent document
- •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 90
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number o
排除标准
- •1. Hypersensitivity to the active substance (losartan) or to any of the excipients
- •2. Patients on other antihypertensive agents of any type. This includes substances inducing hypotension like tricyclic antidepressants, antipsychotics, baclofene, amifostine. Moreover, lithium, NSAIDs (i.e. selective COX-2 inhibitors, acetylsalicylic acid at anti-inflammatory doses and non-selective NSAIDs), fluconazole (inhibitor of CYP2C9), rifampicine (inducer of matabolism enzymes) and drugs that retain potassium (e.g. potassium-sparing diuretics: amiloride, triamterene, spironolactone) or may increase potassium levels (e.g. heparin), potassium supplements or salt substitutes containing potassium are all prohibited during the study
- •3. Patients with hepatic or renal impairment of any reason
- •4. Patients with symptomatic hypotension of any reason
- •5. Patients with primary hyperaldosteronism
- •6. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucosegalactose malabsorption should not take this medicine
- •7. Inadequate recovery from toxicity and/or complications of previous therapy as determined by the treating physician
- •8. Patients with evidence of recurrence less than 3 months since last radiotherapy fraction (Study A – recurrent glioblastoma only)
- •9. A diagnosis of immunodeficiency or hypersensitivity to the PD-1 inhibitors pembrolizumab, or analogs such as atezolizumab, or any of its excipients (Study B patients on immunotherapy only)
- •10. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, coronary heart disease and cerebrovascular disease, unstable angina pectoris, cardiac arrhythmia, angioedema, intravascular volume depletion, or psychiatric illness/social situations that would limit compliance with study requirements
- •11. Patients suffering from aortic or mitral stenosis, or obstructive hypertrophic cardiomyopathy
- •12. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study
- •13. Pregnant or breastfeeding
- •14. Known additional active non-study related malignancy
- •15. Active autoimmune disease that has required systemic treatment in the last 2 years (including use of non-study related disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is allowed
- •16. Known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies)
- •17. Unable to undergo brain MRI according to study protocol
研究者
相似试验
已完成
不适用
on-invasive imaging of perfusion and oxygenation of the LOWer extremities in healthy volunteers by means of Multispectral Optoacoustic Tomography (LOW-MSOT)NL-OMON38860niversitair Medisch Centrum Groningen10
已完成
不适用
Imaging Microcirculation And Gross hemodynamic assessment of the bowel during Elective colorectal Surgerygastrointestinal microcirculationgastrointestinal microvascularisation10017998NL-OMON42295Sint Antonius Ziekenhuis70
撤回
不适用
Imaging Microcirculation And Gross hemodynamic assessment of the Heart during Elective Cardiac Surgerycardiac microcirculation1001108210011954NL-OMON46487Sint Antonius Ziekenhuis20
招募中
Unknown
Developing nuclear imaging test in PADperipheral artery diseaseJPRN-UMIN000053383Saitama Medical University40
招募中
不适用
Perfusion imaging by arterial spin labelling for clinical use in strokeI65.2I66.0I63.2I63.5Occlusion and stenosis of carotid arteryOcclusion and stenosis of middle cerebral arteryCerebral infarction due to unspecified occlusion or stenosis of precerebral arteriesCerebral infarction due to unspecified occlusion or stenosis of cerebral arteriesDRKS00003198Charité Campus Charité Mitte81