Multi-center phase II clinical trial of transarterial embolization using microsphere for painful bone tumors (JIVROSG-1106)

Multi-center phase II clinical trial of transarterial embolization using microsphere for painful bone tumors (JIVROSG-1106) - BoneTACE-II(JIVROSG-1106)

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026121

Enrollment

Registered

2017-03-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

painful bone tumors

Interventions

Transarterial embolization using microsphere for patients with painful bone tumors.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with primary or metastatic bone lesions. 2. Patient with pain due to the bone lesions. 3. Pain score (Numeric Rating Scale: NRS) >=6. 4. Palliative Prognostic Index(P.P.I.)<6. 5. Refractory, recurrent, or no indication for radiation therapy. 6. Adequate organ function within 2weeks WBC>=3000/mm3 Plt>=50000/mm3 Hgb>=8.0g/dl Cr=<2.0mg/dl Bil=<2.0mg/dl 7. Age >= 20 years 8. Written informed consent obtained prior to registration.

Exclusion criteria

Exclusion criteria: 1. Allergy to contrast media. 2. Active infection other than virus hepatitis. 3. Displaced fracture. 4. Uncontrollable pain due to the non-target bone lesion. 5. Radicular pain due to the target lesion. 6. Undetermined location of the pain. 7. Undetermined location of the target lesion on images. 8. Radiation therapy within 4 weeks. 9. Intent of preoperative embolization for bleeding control. 10. Need for transarterial therapies in 2 weeks after procedure. 11. Inability to keep the position during the procedure with drugs and physical therapies. 12. Uncontrollable coagulation disorders. 13. Pregnancy or possibility of pregnancy. 14. The physician in charge considers the patient unsuitable as the subject of this clinical trial.

Design outcomes

Primary

Measure	Time frame
Rate of pain reduction at 2 weeks after the procedure.	—

Secondary

Measure	Time frame
Frequency and grade of complications. Duration of effective pain reduction. Rate of significant pain reduction at 2 weeks after the procedure.	—

Countries

Japan

Contacts

Public ContactYasunori Arai

St.Mariannna University school of Medicine Department of Radiology

yarai1976@gmail.com044(977)8111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026