C25.0 C22.0 C25.1 C25.2 D48.1 D48.4 D48.9
Conditions
Interventions
Group 1: Treatment with ultrasound-guided HIFU system from Chongqing, China (Haifu Company). The therapeutic device is CE-certified for the treatment of solid tumors.
The intervention lasts between 2
Sponsors
Universitätsklinik Bonn
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility and efficacy of ultrasound-guided HIFU in Caucasian patients with solid tumors. Evaluation of tumor reduction using clinical routine imaging (MRI, CT, US). Assessment of symptom reduction using standradized questionnaires (EORTC-QLQ-C30; VAS etc.). 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
| Measure | Time frame |
|---|---|
| Safety of HIFU therapy; Influence on progressionfree and overall survival Recording of shor- and long-term side effects and complications | — |
Countries
Germany
Contacts
Public ContactOlga Ramig
Klinik für Diagnostische und Interventionelle Radiologie, Universitätskliniken Bonn
Outcome results
None listed