Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT02618369
Eligibility Criteria:
Inclusion Criteria:
* Age 5-40 years.
* Able to give informed consent and have parent or guardian give informed consent if applicable.
* Weight \<140 kg (requirement to fit safely on top of the HIFU table and inside the MRI).
* Definitive radiographic \& clinical presentation of osteoid osteoma or other benign tumor lesion(avoiding need for biopsy).
* Pain specifically at the site of interest target lesion.
* Pain score for target lesion \>/= 4 (indicating at least moderate pain) or an age-appropriate pain scale.
* Target lesion is uncomplicated (i.e. no fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
* MR-HIFU treatment date \>/= 2 weeks from most recent surgical treatment of lesion.
Exclusion Criteria:
* Unable to characterize pain specifically at the site of interest (target lesion).
* Pregnant/nursing females.
* Target lesion is complicated (i.e. presence of one of fracture/spinal cord compression/cauda equina syndrome/soft tissue component).
* Target lesion \< 1cm from neurovascular bundles/bowel/hollow viscera or regions of cartilage/ bone growth).
* Target lesion located in skull, spine (excluding sacrum, which is allowed) or sternum.
* Scar along proposed HIFU beam path.
* Orthopaedic implant along proposed HIFU beam path or at site of target tissue.
* Serious cardiovascular, neurological, renal or haematological chronic disease.
* Active infection.
* Contraindication to general anaesthetic or gadolinium MRI contrast agent.
* Requirement for general anesthesia for non-HIFU related MRI's.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
40 Years
Study:
NCT02618369
Study Brief:
Protocol Section:
NCT02618369