Feasibility Study of Suizenji, in Patients With Unresectable Pancreatic Ductal Adenocarcinoma (SUNRISE-II)

Recruiting now · Early Phase 1

Conditions studied: Pancreatic Cancer

In brief

This is a feasibility, safety, tolerability, and efficacy research study of an investigational device called "Suizenji", an ultrasound-guided high-intensity focused ultrasound (HIFU) therapy system for the treatment of unresectable pancreatic ductal adenocarcinoma. Focused ultrasound therapy uses a number of small ultrasound generators attached to a bowl-shaped ultrasound generator to emit ultrasound waves from outside to inside the body and focus them on a single point where cancerous cells in the pancreas are located. The targeted area is then heated, which kills the pancreatic cancer cells, and as a result, the patient's life may be prolonged. Experience with Suizenji for pancreatic cancer patients has shown that the "heating" is only a warm feeling in the abdomen during the treatment.

Key facts

Study ID

NCT07033689

Run by

SONIRE Therapeutics Inc.

People needed

10

Starts

2026-01-05

Expected to finish

2027-03-01

Last updated by the study team

2026-04-03

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Subjects with any cancers other than PDAC who are on active treatment.
• Subjects who had any prior chemotherapy or interventions for PDAC.
• Obstructive jaundice (except for subjects who have a bile duct stent placed for obstructive jaundice prior to initiation of HIFU treatment).
• Tumor embolization in the veins surrounding the pancreas.
• Cysts outside of primary pancreatic tumor which may obstruct the HIFU sonication pathway. However, if the cyst is completely surrounded by pancreatic tumor, the subject can be included.
• Subjects with > 50% reduction in caliber of the principal hepatic artery and occlusion of the portal vein seen on preoperative screening CT or MRI scan.
• Allergy to contrast agents (except when manageable by prophylactic steroid).
• Subjects having a cardiac pacemaker.
• Congestive heart failure, symptomatic coronary artery disease, arrhythmia poorly controlled by drugs, history of myocardial infarction or unstable angina within the past 6 months.
• Subjects with peritoneal dissemination.
• Active infections requiring systemic treatment.
• Pregnancy or women of childbearing potential not willing to follow the birth control as described in the informed consent and/or who are breastfeeding.
• Received unapproved or investigational drug or device within 30 days of the subject's study start date.
• The judgment of the investigator would make the subject inappropriate for entry into the study.

Where it is running

• Stanford University — San Francisco, California, United States (enrolling)

Full record on ClinicalTrials.gov

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