A trial to evaluate the diagnostic performance of contrast-enhanced ultrasonography in pancreatic mass lesions

JRCT ID: jRCT2051220085

Registered date:03/09/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Patients with pancreatic mass lesions (pancreatic solid mass or pancreatic cystic mass)
• Date of first enrollment: 08/09/2022
• Target sample size: 301
• Study type: Interventional
• Intervention(s): During transabdominal ultrasonography and endoscopic ultrasonography for pancreatic masses, contrast-enhanced transabdominal ultrasonography and contrast-enhanced endoscopic ultrasonography are performed after intravenous infusion of a single dose of an ultrasonic contrast agent, perflubutane microbubbles, at 0.015 mL/kg, respectively. For efficacy and safety in diagnosis of pancreatic masses, contrast-enhanced transabdominal ultrasonography and contrast-enhanced endoscopic ultrasonography are compared with plain transabdominal ultrasonography and plain endoscopic ultrasonography, respectively.

Outcome(s)

Primary Outcome

<Cohort 1: Pancreatic solid mass>
Accuracy rate of differential diagnosis: Comparison of plain ultrasonography and contrast-enhanced ultrasonography (transabdominal ultrasonography, endoscopic ultrasonography)
<Cohort 2: Pancreatic cystic mass>
Accuracy rate of differential diagnosis: Comparison of plain ultrasonography and contrast-enhanced ultrasonography (endoscopic ultrasonography)

Secondary Outcome

1Accuracy rate of differential diagnosis (Pancreatic cystic mass): Comparison of plain ultrasonography and contrast-enhanced ultrasonography (transabdominal ultrasonography)
2Assessment of differential diagnostic performance (sensitivity/specificity): Comparison of plain ultrasonography and contrast-enhanced ultrasonography (transabdominal ultrasonography, endoscopic ultrasonography)
3Assessment of differential diagnostic performance (accuracy rate/sensitivity/specificity): Comparison of contrast-enhanced computed tomography and contrast-enhanced ultrasonography (transabdominal ultrasonography, endoscopic ultrasonography)
4Assessment of contrast effects
5Assessment of the confidence degree
6Safety evaluation

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

(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

Exclude criteria

(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

Related Information

• Primary Sponsor: Kitano Masayuki
• Source(s) of Monetary Support: GE Healthcare Pharma Limited