Clinical Trial: Non-invasive Focal Therapy for Osteoid Osteoma

Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Treatment of Osteoid Osteoma With MR Guided High Intensity Focused Ultrasound

Brief Summary: Non-invasive treatment of Osteoid osteoma using MRI guided high-intensity focused ultrasound. This study is designed as an intention-to-treat using a totally non-invasive approach for pain reduction, quality of life improvement and long-term bone restoration. Procedure is performed in a single session using limited amount of acoustic energy to target the osteoid nidus. Treatment will be performed under anesthesia (peripheral or general according to age and lesion position).

Detailed Summary:

An osteoid osteoma is a benign, painful musculoskeletal tumor that usually occurs in young males. The standard of care in the United States is computed tomography (CT)-guided radiofrequency ablation, a minimally invasive percutaneous procedure, with clinical success rates ranging between 85% and 98%.

Percutaneous or surgical therapy can lead to non-negligible side-effects and limited efficacy for pediatric population or young adults with osteoid osteoma. We investigate whether selective focal ablation of osteoid lesions can reduce this treatment burden without compromising long-term clinical efficacy.

Treatments will be performed using a 3.0-T MR unit (Discovery MR 750; GE Medical Systems, Milwaukee,Wis) featuring a Conformité Européenne-approved ExAblate MR-guided focused ultrasound system (InSightec,Tirat-Carmel, Israel) in which the ultrasound transducer is housed in the patient table. Alignment between the lesion and the transducer will be obtained in each patient by using a moistened gel pad and degassed water for acoustic coupling. This approach avoided air- skin interfaces, which can cause energy reflection and skin burns. After patient positioning, the lesion is localized with MR for treatment by using variably orientated non enhanced T1- and T2-weighted acquisitions. In general, an ideal 90° incidental angle between the planned focused ultrasound path and the lesion, relative to the bone long axis, is obtained or at least approximated. The shortest skin-lesion distance is selected for the beam pathway. Care will be taken to avoid multiple interfaces (skin, muscle, fasciae) as much as possible so as to minimize deflection of the focused ultrasound beam. Each lesion will be manually segmented by the operator to precisely delineate the nidus, skin surface, and cortical surface of the bone. Sensitive ar
Sponsor: University of Roma La Sapienza

Current Primary Outcome:

  • Safety - Adverse Events (serious and otherwise) [ Time Frame: 1 year ]
    to assess complications
  • Efficacy (Symptoms reduction) [ Time Frame: 4 years ]
    Symptoms reduction


Original Primary Outcome: Same as current

Current Secondary Outcome: nidus vascularization (correlation between nidus vascularization reduction and symptoms relieve) [ Time Frame: 4 years ]

correlation between nidus vascularization reduction and symptoms relieve


Original Secondary Outcome: Same as current

Information By: University of Roma La Sapienza

Dates:
Date Received: November 19, 2014
Date Started: June 2010
Date Completion: December 2015
Last Updated: November 24, 2014
Last Verified: November 2014