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Multi-centered, randomized two-arm parallel group comparison, Superiority clinical trial for evaluating the safety and the efficacy of the focused ultrasound therapy system for bone metastases

Multi-centered, randomized two-arm parallel group comparison, Superiority clinical trial for evaluating the safety and the efficacy of the focused ultrasound therapy system for bone metastases

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024553
Enrollment
Unknown
Registered
2019-07-16
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain palliation of the bone metastases

Interventions

Experimental group:Focus Ultrasound Treatment

Sponsors

Shanghai General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged from 18~70 years; 2. Patients who has been diagnosed as bone metastases according to the medical history or MR examination; 3. The target metastases is back to the ribs, limbs, pelvis, shoulder joint and spine under the L3 vertebral (included); 4. Target lesion is clearly observed under the non-enhanced magnetic resonance imaging; 5. Irrespective of medication, patient with NRS (0-10 scale) pain score >=4, The source of pain can be distinguished, and targeted part of the treatment NRS pain score is at least 2 scores higher than the other pain parts; 6. Patient haven't received radiation therapy to the targeted(most painful) lesion in the past two weeks prior to the study; 7. Patients who are voluntary and have given written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who receive chemotherapy aimed at palliating or radiation therapy to targeted painful lesion in the past two weeks prior to the study; 2. Fracture risk score >7; 3. The skin on the beam pathway has damage or ulceration; 4. Disease which have an inclination of bleeding; 5. Patients with life expectancy 100 on medication); 9. Patients with standard contraindications for MR imaging such as non-MRI compatible implanted metallic devices or claustrophobia; 10. Patients who have mental disorder in the past or have recognition disable; 11. Pregnancy or Lactation; 12. Patients who are participating or have participated in another clinical trial in the past 30 days; 13. Patients who are in other circumstances which the researchers regards are not appropriate for clinical trial.

Design outcomes

Primary

MeasureTime frame
The efficacy of HIFU treatment for pain palliation of bone metastases 90±7 days after the surgery;

Secondary

MeasureTime frame
the numerical rating scale circumstances before the surgery and 7±1days, 30±7days and 90±7days after the surgery Secondary Outcome Measures;he score of brief pain inventory-quality of life (BPI-QoL) before and 7±1 days, 30±7 days and 90±7 days after the surgery;the record of pain medications usage.;

Countries

China

Contacts

Public ContactWang Han

Shanghai General Hospital

han.wang@shgh.cn+86 13564112852

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026