UMIN ID: UMIN000001501
Registered date:12/11/2008
A phase I/II study of percutaneous radiofrequency ablation for osteoid osteoma (JIVROSG-0704)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | osteoid osteoma |
| Date of first enrollment | 2008/04/01 |
| Target sample size | 21 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Following the percutaneous insertion of a radiofrequency needle, radiofrequency ablation of nidus of osteoid osteoma is to be performed. |
Outcome(s)
| Primary Outcome | Safety. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1) Cardiac pacemaker. 2) Vital artery or nerve on the needle route. 3) Vital neural structures in the field of ablation. 4) Maximum diameter of the target lesion (i.e. nidus) > 1.5cm. 5) Pretreatment Visual Analogue Scale < 2. 6) Previous locoregional treatment for the target lesion. 7) Not applicable for anesthesia (general, spinal, or epidural). 8) Pregnant. 9) Not eligible determined by the responding physician. |
Related Information
| Primary Sponsor | Japan Interventional Radiology in Oncology Study Group (JIVROSG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yasuaki Arai |
| Address | 5-1-1, Tsukiji, Chu0-ku, Tokyo, 104-0045, Japan Japan |
| Telephone | 03-3542-2511 |
| jivrosgoffice@ml.res.ncc.go.jp | |
| Affiliation | JIVROSG, Coordinating Office Division of Diagnostic Radiology, National Cancer Center Hospital |
| scientific contact | |
| Name | Keigo Endo |
| Address | 3-39-15, Showa-cho, Maebashi 3718511, JAPAN Japan |
| Telephone | |
| Affiliation | Gunma University Department of Radiology and Radiation Oncology |