Advanced CancerSE-BGCU-MBTNCT07540468
Safety Evaluation of Bioactive Glass Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors
A study testing Bioactive Glass Bone Cement + Ultrasound in people with Advanced Cancer and Pain, run by Liao Yun.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Advanced Cancer, Pain
- What is being tested?
- Bioactive Glass Bone Cement + Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Advanced Cancer, Pain
- Being tested
- Bioactive Glass Bone Cement + Ultrasound
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bioactive Glass Bone Cement + UltrasoundOther
Bioactive Glass Bone Cement + Ultrasound
| Study group | Role | What they receive |
|---|---|---|
| BG-Bone Cement + Ultrasound Treatment Group | Experimental | Not described Receives: Other: Bioactive Glass Bone Cement + Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Event/Adverse Reaction Incidence Rate
Measured: 12 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liao Yun
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Liao Yun, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07540468
- Sponsor's protocol ID
- 20251115101641097
- Other IDs
- U23A20692
- Acronym
- SE-BGCU-MBT
- Status last verified
- Apr 2026
- First submitted
- 13 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety Evaluation of Bioactive Glass-Based Bone Cement Combined With Ultrasound in Implantation for Metastatic Bone Tumors
- ClinicalTrials.gov ID
- NCT07540468
- Acronym / sponsor ID
- SE-BGCU-MBT / 20251115101641097
- Conditions
- Advanced Cancer, Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Liao YunUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 20 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BG-Bone Cement + Ultrasound Treatment Group | Experimental | Other: Bioactive Glass Bone Cement + Ultrasound |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bioactive Glass Bone Cement + UltrasoundBioactive Glass Bone Cement + Ultrasound | Other | BG-Bone Cement + Ultrasound Treatment Group |
Primary outcome
Adverse Event/Adverse Reaction Incidence Rate
Time frame: 12 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Bioactive Glass Bone Cement + Ultrasound in people with Advanced Cancer and Pain, run by Liao Yun.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Shanghai general hospital (+86-021-63240090, 191434914@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event/Adverse Reaction Incidence Rate (time frame: 12 months postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.