NIPH Clinical Trials Search

UMIN ID: UMIN000001500

Registered date:12/11/2008

A phase II study of percutaneous osteoplasty for painful malignant bone tumor (JIVROSG-0703)

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedMalignant vertebral and pelvic bone tumor
Date of first enrollment2008/04/01
Target sample size33
Countries of recruitmentJapan
Study typeInterventional
Intervention(s)Under local anesthesia and fluoroscopic or CT guidance, a needle is percutaneously inserted into the malignant bone tumor and the cement is injected.


Primary OutcomeClinical efficacy
Secondary OutcomeAdverse events and QOL

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximumNot applicable
GenderMale and Female
Include criteria
Exclude criteria1) Cardiac failure requiring medication. 2) Vertebral tumor with destruction of the posterior part of vertebral body or compression of spinal cord. 3) Require the treatment of more than 4 vertebral bodies at single session. 4) Destruction of the bone cortex of aceatabulum. 5) No severe pain (less than 2 of VAS). 6) Uncontrolled bleeding tendency. 7) Severe drug allergy. 8) Comorbid infectious disease. 9) Active inflammatory process in the target lesion. 10) Radiation therapy for the target lesion. 11) Within 4 weeks after the completion of radiation therapy with a treatment response. 12) Unable to keep prone position for 1 hour. 13) Pregnancy.

Related Information


public contact
Name Yasuaki Arai
Address 5-1-1,Tsukiji,Chuo-ku,Tokyo,104-0045,Japan Japan
Telephone 03-3542-2511
Affiliation JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital
scientific contact
Name Osamu Matsui
Address 13-1, Takaramachi, Kanazawa 920-8641, Japan Japan
Telephone 076-265-2323
Affiliation Kanazawa University Graduate School of Medicine Department of Radiology