The safety trial of sonodynamic therapy for unresectable intractable cancer

Phase 1

Recruiting

• Conditions: unresectable intractable cancer

• Registration Number: JPRN-UMIN000027283
• Lead Sponsor: Tokyo Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-10
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

1.The patients who has cancer of other organs or is suspected 2.The treatment history of radiotherapy 3.The treatment history of chemotherapy before registration within one month 4.The treatment history of HIFU therapy before registration within two months 5.The patients by whom heomostatic troubles, such as an antiplatelet therapy and an anticoagulation, are expected 6.The patients who has invasion of cancer to stomach and duodenum 7.The patients who has obstructive jaundice (the patients after removing of obstruction is available) 8.The patients by whom tumor adjoins the vena cava inferior and tumor emboli exist in a vena cava inferior (however, good, if the site is avoided) 9.The patients by whom tumor adjoins aorta and a calcified lesion is an exist (however, good, if the site is avoided) to aorta 10.The patients who has cystic lesion in pancreatic cancer 11.The patients of the use history of anthracycline drug 12.The patients who has an anamnestic of a critical drug hypersensitivity 13.The patients who has a radiocontrast-agent allergy 14.The patients who has a critical encephalopathy and pulmonary disease (pneumonitis, pulmonary fibrosis which can be checked on an imaging) 15.The patients who has an anamnestic of congestive heart failure, a symptomatic coronary artery disease, an irregularity of pulse with poor control with medicament, myocardial infarction for less than six months, or unstable angina 16.The patients who has an active infective disease which needs a systemic treatment 17.Pregnant women or the patients who may have become pregnant, and the out-of patient of a contraceptive intention 18.The patients who judged that principal investigator was unsuitable as subject

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The safety of SDT during SDT and for 1 week and 1 month after SDT

Secondary Outcome Measures

Name	Time	Method
the anti-tumor effect and the symptom relief effect for 2 months after SDT