A Prospective Study on the Enhancement of Cell-free DNA Detection Sensitivity Using Ultrasound Contrast Agent (Perflubutane)

JRCT ID: jRCTs071240095

Registered date:10/01/2025

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 10/01/2025
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Perfluorobutane is administered intravenously the day before surgery for pancreatic cancer.

Outcome(s)

• Primary Outcome: Quantification of cf-DNA measurement sensitivity and change in detection amount before, 5 minutes, 15 minutes, 30 minutes, and 60 minutes after administration of perfluorobutane
• Secondary Outcome: N/A

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include criteria

1. Target Disease: Patients with confirmed diagnosis of pancreatic ductal adenocarcinoma (PDAC).
2. Disease Stage: All pancreatic cancer cases prior to chemotherapy administration.
3. Age: Between 18 and 85 years.
4. Gender: No restriction.
5. Consent: Written informed consent obtained from the patient.
6. Study Period: Patients undergoing surgery in the Department of Hepato-Biliary-Pancreatic Surgery and Transplantation, Nagasaki University Hospital, with institutional approval obtained by March 31, 2027.

Exclude criteria

1. Patients with allergies to eggs or egg products
2. Patients with arteriovenous(right-to-left) shunts in the heart or lungs
3. Patients with severe heart disease
4. Patients with severe lung disease
5. Pregnant women
6. Breastfeeding women

Related Information

• Primary Sponsor: Imamura Hajime