High-intensity focused ultrasound (HIFU) for local ablative therapy of solid tumors

Not Applicable

Recruiting

• Conditions: C25.0; C22.0; C25.1; C25.2; D48.1; D48.4; D48.9; Head of pancreas; Liver cell carcinoma; Body of pancreas

• Registration Number: DRKS00007855
• Lead Sponsor: niversitätsklinik Bonn

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03-06
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Age: 18 years or older, legal capacity
• Gender: men and women
• Patients with solid tumors (hepatocellular carcinoma, liver metastases, bile duct cancer, pancreatic cancer, uterine fibroids, peripheral bone tumors)
• the solid tumor is sufficient detectable by ultrasound
• tumor board decision for HIFU treatment (non-resectable tumors)
• ECOG (Eastern Cooperative Oncology Group) <3

Exclusion Criteria

• Participation in another clinical study
• Surgical resection is possible (decision of the interdisciplinary tumor board)
• Patient noteligible for anesthesia
• Patients who are unable, in the opinion of the investigator, to enter the follow-ups
• Pregnancy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility and efficacy of ultrasound-guided HIFU in Caucasian patients with solid tumors.<br>Evaluation of tumor reduction using clinical routine imaging (MRI, CT, US).<br>Assessment of symptom reduction using standradized questionnaires (EORTC-QLQ-C30; VAS etc.).<br>Evaluation at baseline and follow-up (at 1 and 6 weeks, 3 months and every 3 months after HIFU treatment for a period of at least one year

Secondary Outcome Measures

Name	Time	Method
Safety of HIFU therapy; Influence on progressionfree and overall survival<br><br>Recording of shor- and long-term side effects and complications