A Prospective, Multi-National, Randomized, Double-Blind, Crossover Study to Evaluate the Efficacy and Safety of Gadopiclenol-enhanced MRA Compared to Gadoterate Meglumine-enhanced MRA in the Assessment of Steno-occlusive Disease in Adult Patients With Suspected Vascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Guerbet
- 入组人数
- 315
- 试验地点
- 74
- 主要终点
- Non-inferiority
研究概览
简要总结
Compare the diagnostic performance of gadopiclenol against gadoterate meglumine in patients with vascular diseases of supra-aortic, peripheral, or abdominal / renal arteries using MRI
详细描述
To prospectively compare the diagnostic performance of gadopiclenol with gadoterate meglumine given at a dose of 0.1 mmol/kg in the diagnosis and evaluation of vascular diseases of supra-aortic (carotid/vertebrobasilar), peripheral or abdominal/renal arteries using commercial MRI scanners and MRA sequences.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years of age or older willing to participate in the trial and follow all study procedures specified in the protocol.
- •Patient having read the information in the ICF and having provided his/her consent to participate in writing by dating and signing the ICF prior to any trial related procedure being conducted.
- •Patient with suspected steno-occlusive disease in supra-aortic (carotid/vertebrobasilar) (a), peripheral (b) or abdominal/renal (c) arteries based on:
- •clinical signs and symptoms including but not limited to prior stroke, transient ischemic attack (TIA), amaurosis fugax (transient monocular blindness) and/or previous diagnostic tests (CTA, IA-DSA, or ultrasound) or
- •symptoms of lower-extremity arterial disease (stages II-IV according to the Leriche-Fontaine classification, or 1 to 6 according to Rutherford classification 113 and/or confirmed by previous imaging (Doppler ultrasound, CTA, MRA, IADSA) or
- •suspected renovascular hypertension based on one or more of the following criteria:
- •i. hypertension refractory to standard therapy ii. acute worsening of pre-existing hypertension iii. abrupt onset of sustained, moderate to severe hypertension at age <35 years suggestive of fibromuscular dysplasia (FMD) iv. progressive renal insufficiency (creatinine > 2 mg/dL; no other apparent cause of progressive renal failure based on routine medical history, physical examination, 24-h urine collection and urinary protein excretion) v. abnormal/inconclusive renal doppler ultrasound. vi. other criteria (to be specified)
- •Are scheduled for or had undergone CTA and/or IA-DSA according to imaging standards to cover the supra-aortic (carotid/vertebrobasilar) and/or peripheral and/or abdominal/renal territory described in this protocol.
排除标准
- •Is a pregnant or lactating female. Exclude the possibility of pregnancy for women of childbearing potential:
- •by testing on site at the institution (serum βHCG or urine)
- •by surgical history (e.g., tubal ligation or hysterectomy)
- •post-menopausal with a minimum 1 year without menses.
- •Has any known allergy to one or more of the ingredients in the investigational products or has a history of hypersensitivity to other GBCAs.
- •Has severe renal impairment defined as an estimated glomerular filtration rate (eGFR) below 30 mL/min/1.73 m2 calculated using the Modification of Diet in Renal Disease (MDRD) formula.
- •Has known or suspected acute kidney injury (AKI) based on: a. Increase in serum creatinine by ≥ 0.3 mg/dL (≥ 26.5 μmol/L) within 48 hours or b. Increase in serum creatinine to ≥ 1.5 times baseline, which is known or presumed to have occurred within prior 7 days or c. Urine volume < 0.5 mL/kg/h for 6 hours
- •Has received any contrast agent (for MRI, CT, DSA) prior to the first IMP administration or is scheduled to receive any contrast agent between the two MRA or after the second IMP administration.
- •Has received or is scheduled for therapeutic intervention (e.g., endovascular therapy, vascular surgery, etc.) of any kind for vascular disease in the arterial territory of interest performed between the 2 MRA procedures or between the study MRAs and the CTA/IADSA procedures when applicable.
- •Has any contraindications to MRI.
- •Is suffering from severe claustrophobia.
- •Has received an investigational drug or medical device before admission into this study or scheduled to receive any investigational treatment in the course of the trial.
- •Was previously included in this trial.
- •Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or post-dose follow-up examinations.
研究组 & 干预措施
AB
Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg
干预措施: gadopiclenol (Drug)
AB
Gadopiclenol administered first followed by Gadoterate meglumine 0.1 mmol/kg
干预措施: Gadoterate meglumine (Dotarem) (Drug)
BA
Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol
干预措施: gadopiclenol (Drug)
BA
Gadoterate meglumine 0.1 mmol/kg administered first followed by Gadopiclenol
干预措施: Gadoterate meglumine (Dotarem) (Drug)
结局指标
主要结局
Non-inferiority
时间窗: 30 days
To demonstrate the non-inferiority of gadopiclenol-enhanced Magnetic Resonance Angiography (MRA) compared to gadoterate meglumine enhanced MRA at 0.1 mmol/kg body weight in terms of sensitivity and specificity for detecting clinically significant steno-occlusive disease at segment level using Computerized Tomography Angiography (CTA) and/or Intra-arterial-Digital Subtraction Angiography (IA-DSA) findings as Standard of Truth.
次要结局
- Adverse Events(30 days)