EUCTR2018-003946-18-DE进行中（未招募）1 期
Efficacy and safety of gadopiclenol for body magnetic resonance imaging (MRI) - PROMISE trial
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
- GUERBET
- 入组人数
- 300
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
- •1.Female or male adult patient having reached legal majority age.
- •2.Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region among head & neck, thorax (including breast), abdomen (including liver, pancreas and kidney), pelvis (including uterus, ovary and prostate) and musculoskeletal (including extremities) based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
- •3.Patient scheduled for a contrast-enhanced MRI examination of a body region for clinical reasons and agreeing to have a second contrast-enhanced MRI examination for the purpose of the trial.
- •4.If the patient was treated (either with radiation, surgery, biopsy or other relevant treatments) between previous imaging evaluation and trial MRI, there should still be a high suspicion of remaining enhancing abnormality(ies) and/or lesion(s) on the basis of available clinical information.
- •5.Patient able and willing to participate in the trial.
- •6.Patient having read the information and having provided his/her consent to participate in writing by dating and signing the informed consent prior to any trial related procedure being conducted.
- •7.Patient affiliated to national health insurance according to local regulatory requirements.
- •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 225
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 75
排除标准
- •1.Patients with known or suspected lesion(s) referred for contrast-enhanced MRI of CNS or of heart or for MR Angiography.
- •2.Patient presenting with known class III/IV congestive heart failure according to the New York Heart Association classification (NYHA).
- •3.Patient having received any investigational medicinal product within 7 days prior to trial entry or scheduled to receive any investigational treatment in the course of the trial.
- •4.Patient previously randomized in this trial.
- •5.Patient presenting with any contraindication to MRI examinations.
- •6.Patient having received any contrast agent (for MRI or CT) within 3 days prior to trial products administration, or scheduled to receive any contrast agent during the course of the trial or within 24 hours after the second trial product administration.
- •7.Patient expected/scheduled to have any treatment or medical procedure (e.g. chemotherapy, radiotherapy, biopsy or surgery etc…) that may impact the aspects of the imaged lesions between the 2 MRI examinations. (Patients under corticosteroids and/or maintenance chemotherapy with a stable dose at the time of screening visit and throughout the trial can be included).
- •8.Patient with anticipated, current or past condition (medical, psychological, social or geographical) that would compromise the patient’s safety or her/his ability to participate in the trial.
- •9.Patient unlikely to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits and/or unlikelihood of completing the trial.
- •10.Patient related to the Investigator or any other trial staff or relative directly involved in the trial conduct.
- •11.Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
- •12.Pregnant or breast-feeding female patient (a female patient of childbearing potential or with amenorrhea for less than 12 months must have a negative urine pregnancy test within 1 day prior to trial MRI and must be using highly effective birth controlled method until the last trial visit).
- •13.Patient with known contra-indication(s) to the use or with known sensitivity to one of the products under investigation or to other GBCAs (such as hypersensitivity, post contrast acute kidney injury).
研究者
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