High powered ultrasound to treat pancreas cancer

Phase 2

• Conditions: ocally advanced pancreatic cancer; Cancer; Malignant neoplasm of pancreas

• Registration Number: ISRCTN56087634
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-07-22
• Last Update Posted: 23 May 2022
• Study Completion: 2022-06-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1. Histologically or cytologically confirmed adenocarcinoma
2. Locally advanced inoperable pancreatic ductal adenocarcinoma and or operable pancreatic ductal cancers but patients not fit for surgery
3. A measurable primary tumour on ultrasound imaging, with a target area of less than 8 cm in diameter on CT/MRI
4. A clear 1 cm margin between the tumour and associated organs (duodenum, stomach, transverse colon) on contrast-enhanced MR imaging
5. Biliary obstruction to be relieved before inclusion in the study
6. Age greater than or equal to 18 years
7. Fit for general anaesthesia
8. Performance status: ECOG =2
9. An American Society of Anaesthesiologists (ASA) grade of =3
10. Life expectancy: At least 12 weeks
11. Able to attend for long-term follow-up
12. No concurrent malignancy
13. No serious medical or psychological condition
14. Ability to give fully informed consent

Exclusion Criteria

1. Patients with TNM Stage IV (metastatic disease)
2. Unclear cancer margins on ultrasound imaging
3. Invasion into the duodenal wall
4. Stricture of superior mesenteric artery directly by tumour encasement, or invasion of SMV below transverse mesocolon
5. Patient suitable for surgical resection
6. Refusal to give informed consent
7. Unable to give informed consent
8. Not fit for HIFU treatment: any significant disease, disorder, or finding which, in the opinion of the investigator, may significantly increase the risk to the patient because of participation in the study
9. Active or ongoing infection requiring IV antibiotics
10. Known pregnancy

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Safety of HIFU therapy for pancreatic cancer measured using 30-day survival & adverse events and serious adverse events recorded using Clavien-Dindo grading