PMID- 27491406 OWN - NLM STAT- MEDLINE DCOM- 20170330 LR - 20181202 IS - 1432-086X (Electronic) IS - 0174-1551 (Linking) VI - 39 IP - 10 DP - 2016 Oct TI - Phase I/II Multi-Institutional Study of Percutaneous Radiofrequency Ablation for Painful Osteoid Osteoma (JIVROSG-0704). PG - 1464-70 LID - 10.1007/s00270-016-1438-7 [doi] AB - PURPOSE: This multicenter prospective study was conducted to evaluate the safety and efficacy of percutaneous radiofrequency ablation (RFA) for painful osteoid osteoma (OO). MATERIALS AND METHODS: Patients with OO (femur: n = 17, tibia: n = 2, humerus: n = 1, rib: n = 1) were enrolled and treated with RFA. In phase I, nine patients were evaluated for safety. In phase II, 12 patients were accrued, and an intent-to-treat analysis was performed on all patients. The primary endpoint was to evaluate the treatment safety. The secondary endpoint was to evaluate the efficacy for pain relief by the visual analogue scale (VAS) at 4 weeks after RFA. Treatment efficacy was classified as significantly effective (SE) when VAS score decreased by >/=5 or score was <2, moderately effective when VAS score decreased by <5->/=2 and score was >/=2, and not effective (NE) when VAS score decreased by <2 or score was increased. Cases where the need for analgesics increased after treatment were also NE. RESULTS: RFA procedures were completed in all patients. Minor adverse effects (AEs) were observed as 4.8-14.3 % in 12 patients, and no major AEs were observed. Mean VAS score was 7.1 before treatment, 1.6 at 1 week, 0.3 at 4 weeks, and 0.2 at 3 months. All procedures were classified as SE. Pain recurrence was not noted in any patient during follow-up (mean: 15.1 months). CONCLUSION: RFA is a safe, highly effective, and fast-acting treatment for painful extraspinal OO. Future studies with a greater number of patients are needed. FAU - Miyazaki, Masaya AU - Miyazaki M AD - Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. mmiyazak@gunma-u.ac.jp. FAU - Arai, Yasuaki AU - Arai Y AD - Division of Diagnostic Radiology, National Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Myoui, Akira AU - Myoui A AD - Medical Center for Translational Research, Osaka University Hospital, 2-15 Yamadaoka, Suita, Osaka, 565-0871, Japan. FAU - Gobara, Hideo AU - Gobara H AD - Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama, 700-8558, Japan. FAU - Sone, Miyuki AU - Sone M AD - Division of Diagnostic Radiology, National Center Hospital, 5-1-1, Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan. FAU - Rosenthal, Daniel I AU - Rosenthal DI AD - Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit Street, Boston, MA, 02114, USA. FAU - Tsushima, Yoshito AU - Tsushima Y AD - Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. FAU - Kanazawa, Susumu AU - Kanazawa S AD - Department of Radiology, Okayama University Medical School, 2-5-1 Shikatacho, Kita-ku, Okayama, 700-8558, Japan. FAU - Ehara, Shigeru AU - Ehara S AD - Department of Radiology, Iwate Medical University School of Medicine, 19-1 Uchimaru, Morioka, 020-8505, Japan. FAU - Endo, Keigo AU - Endo K AD - Department of Interventional Radiology and Clinical Ultrasound Center, Gunma University Hospital, 3-39-15, Showa-machi, Maebashi, Gunma, 371-8511, Japan. LA - eng PT - Clinical Trial, Phase I PT - Clinical Trial, Phase II PT - Journal Article PT - Multicenter Study DEP - 20160804 PL - United States TA - Cardiovasc Intervent Radiol JT - Cardiovascular and interventional radiology JID - 8003538 SB - IM MH - Adult MH - Bone Neoplasms/pathology/*surgery MH - Cancer Pain/pathology/*surgery MH - Catheter Ablation/*methods MH - Female MH - Humans MH - Intention to Treat Analysis MH - Male MH - Middle Aged MH - Neoplasm Recurrence, Local/surgery MH - Osteoma, Osteoid/pathology/*surgery MH - Pain Measurement MH - Postoperative Complications/etiology MH - Prospective Studies MH - Tomography, X-Ray Computed/methods MH - Treatment Outcome OTO - NOTNLM OT - Clinical trial OT - Osteoid osteoma OT - Radiofrequency ablation EDAT- 2016/08/06 06:00 MHDA- 2017/03/31 06:00 CRDT- 2016/08/06 06:00 PHST- 2016/06/20 00:00 [received] PHST- 2016/07/26 00:00 [accepted] PHST- 2016/08/06 06:00 [entrez] PHST- 2016/08/06 06:00 [pubmed] PHST- 2017/03/31 06:00 [medline] AID - 10.1007/s00270-016-1438-7 [pii] AID - 10.1007/s00270-016-1438-7 [doi] PST - ppublish SO - Cardiovasc Intervent Radiol. 2016 Oct;39(10):1464-70. doi: 10.1007/s00270-016-1438-7. Epub 2016 Aug 4.