Safety Evaluation of Bioactive Glass Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors (SE-BGCU-MBT)

Safety Evaluation of Bioactive Glass-Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors

This study is evaluating the safety of using bioactive glass-containing bone cement combined with ultrasound during surgery for patients with metastatic bone tumors. We aim to see if this treatment can be safely applied to stabilize the bone and reduce pain, without causing unexpected side effects. All participants will receive standard care plus the study treatment, and we will closely monitor them during and after the procedure to check for any safety concerns.

Study Overview

• Status: Not yet recruiting
• Conditions: Pain; Advanced Cancer
• Intervention / Treatment: Other: Bioactive Glass Bone Cement + Ultrasound

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shanghai general hospital; Phone Number: +86-021-63240090; Email: 191434914@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 1.Age between 18 and 80 years (inclusive), regardless of gender; 2. Patients with advanced cancer, presenting with intractable pain due to clinically, radiologically and pathologically confirmed pelvic metastases; 3. Osteolytic lesions primarily located in the periacetabular or non-periacetabular regions; 4. Expected survival of more than 1 year; 5. Voluntarily agree to participate in this clinical trial, and the subject and/or their legal guardian is willing and able to provide written informed consent; 6. Demonstrates good compliance, is willing to follow medical advice, and is able to attend all required follow-up visits as specified in the protocol.

Exclusion Criteria:

• 1. Relative surgical contraindications, such as pelvic discontinuity or fracture displacement > 5 mm; 2. Poor general health status with an estimated survival of less than 3 months; 3. Destruction of the inner iliac cortex associated with soft tissue masses affecting vital organs, nerves, or blood vessels; 4. Presence of active systemic infection; 5. Previous history of bone cement injection at the target lesion site; 6. Severe hepatic or renal dysfunction (Child-Pugh class C, eGFR < 30 mL/min); 7. Coagulopathy or bleeding diathesis; 8. Known hypersensitivity or allergy to bone cement components; 9. Poor adherence, unwilling or unable to comply with postoperative treatment and/or rehabilitation regimens; 10. Patients who are mentally incompetent or unable to understand the requirements of study participation; 11. Unable to attend follow-up visits at the study institution; 12. Participation in another clinical trial within 3 months prior to enrollment in this study; 13. Pregnant or breastfeeding women.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BG-Bone Cement + Ultrasound Treatment Group	Other: Bioactive Glass Bone Cement + Ultrasound; Bioactive Glass Bone Cement + Ultrasound

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Adverse Event/Adverse Reaction Incidence Rate	12 months postoperatively

Collaborators and Investigators

• Sponsor: Liao Yun

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): April 30, 2028

Study Registration Dates

• First Submitted: April 13, 2026
• First Submitted That Met QC Criteria: April 13, 2026
• First Posted (Actual): April 20, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 13, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: 20251115101641097; U23A20692 (Other Grant/Funding Number: National Natural Science Foundation of China)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No