JPRN-jRCT2051220085招募中3 期
A multi-center confirmatory trial to evaluate the differential diagnostic performance of contrast-enhanced ultrasonography using Perflubutane in patients with pancreatic mass lesions - GE-045
Kitano Masayuki0 个研究点目标入组 301 人开始时间: 2022年9月3日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 301
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients with an untreated pancreatic solid mass or pancreatic cystic mass (as a lesion of interest) on plain transabdominal ultrasonography (P-TUS)
- •(2)Patients scheduled for pathological examination, such as endoscopic ultrasonography -guided fine needle aspiration (EUS-FNA), or surgery. For patients with a pancreatic cystic mass, those who are scheduled for surgery by suspecting it as a malignant mass.
- •(3)Male or female inpatients or outpatients aged 20 years or older at the time of informed consent
- •(4)Patients who are competent to comply with the trial procedures and willing to participate in the trial and who have submitted a signed and dated consent form
排除标准
- •(1)Patients with hypersensitivity to any of the components in the study drug
- •(2)Patients with a history of allergy to egg or egg products
- •(3)Patients with an arteriovenous (right-left) shunt in the heart or the lung
- •(4)Patients with a serious heart disease or serious lung disease
- •(5)Patients who have undergone gastrectomy
- •(6)Patients with acute, clinically fatal conditions
- •(7)Patients with a history of allergy to iodine contrast agents
- •(8)Patients unable to undergo contrast-enhanced computed tomography (CT).
- •(9)Pregnant or potentially pregnant patients, nursing patients, or patients who do not agree to use contraception during the trial period
- •(10)Patients who have received any treatment for cancer, such as drug therapy including chemotherapy or radiotherapy, or who are scheduled to receive any of these treatments from the time of signing informed consent to the completion of pathological examination
- •(11)Patients known to have pancreatic carcinoma
- •(12)Patients participating in or scheduled to participate in another clinical trial or intervention trial, or those who participated in another clinical trial or intervention trial within past 90 days
- •(13)Patients who have undergone or scheduled to undergo another contrast radiography (e.g., examinations using an iodine contrast agent, MRI contrast agent, or other ultrasonic contrast agents) between 3 days before and 2 days after the study drug administration
- •(14)Patients who are scheduled to undergo gastrointestinal examinations, such as laparoscopy or barium examination using a foaming agent, on the day of the study drug administration
- •(15)Other patients who are deemed inappropriate for participation in the trial by the principal investigator or subinvestigator
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