Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children

NCT02349971 | Completed DMC

• 1 other identifier: HIFU OO
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

This study looks to examine the feasibility and efficacy of using MR-HIFU to ablate Osteoid Osteoma lesions in children and young adults.

Conditions

Osteoid Osteoma

Outcome Measures

Primary Outcomes (1)

• Safety and feasibility measured by the number of patients who are able to be treated with MR HIFU and do not experience significant treatment related adverse events.

  Safety and feasibility will be measured by the number of patients who are able to be treated with MR HIFU and do not experience significant treatment related adverse events.

  12 months

Secondary Outcomes (1)

• Response

  12 months

Study Arms (1)

All Patients

EXPERIMENTAL

Patients will undergo a one-time procedure of MR-HIFU ablation of OO under sedation or anesthesia. Patients will be monitored for disease status and adverse events for at least 12 months following procedure.

Device: MR-HIFU

Interventions

MR-HIFU DEVICE

Magnetic Resonance guided High Intensity Focused Ultrasound (MR-HIFU) provides precise and controlled delivery of focused ultrasound energy inside a lesion using an external applicator, without the need for a scalpel or needle

All Patients

Eligibility Criteria

• Age: Up to 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosis:
• All patients with a clinical suspicion of OO based on presence of typical symptoms of localized nocturnal pain that is relieved by NSAIDs and unrelated to trauma or activity.
• Typical imaging findings on CT and/or MRI. Plain radiographs and bone scans may be obtained by referring physicians and are helpful for confirming the clinical diagnosis but cannot be substituted for a CT or MRI.
• Non-contrast enhanced or contrast enhanced CT studies are acceptable.
• Contrast enhanced MRI studies should be performed.
• Tissue biopsy is not required
• Tumor location:
• Target lesions can be located in any peripheral bone with acoustic accessibility.
• Target lesions may be intracortical or juxtacortical in location.
• Target lesions must be reachable within the normal safety margins of HIFU as specified in the instructions for use.
• Prior therapy:
• ●Patients with prior unsuccessful surgical resection or RFA are eligible for enrollment.
• Laboratory :
• Hemoglobin \> 9 g/dL
• Platelet count ≥75,000/µL (may receive transfusions)

You may not qualify if:

• Clinically significant unrelated systemic illness, such as serious infections, hepatic, renal or other organ dysfunction, which in the judgment of the Principal or Associate Investigator would compromise the patient's ability to tolerate the general anesthetic required for the procedure.
• Implant or prosthesis or scar tissue within the path of the HIFU beam.
• Target \<1 cm from nerve plexus, spinal canal, bladder, bowel
• Target \<1 cm of the growth plate (physis)
• Lesion in the skull or vertebral body
• Inability to undergo MRI and/or contraindication for MRI
• Inability to tolerate stationary position during HIFU
• Patients currently receiving any investigational agents.

Sponsors & Collaborators

• Children's National Research Institute: lead

Study Sites (1)

Children's National Hospital

Washington D.C., District of Columbia, 20012, United States

Location

Related Publications (1)

• Sharma KV, Yarmolenko PS, Celik H, Eranki A, Partanen A, Smitthimedhin A, Kim A, Oetgen M, Santos D, Patel J, Kim P. Comparison of Noninvasive High-Intensity Focused Ultrasound with Radiofrequency Ablation of Osteoid Osteoma. J Pediatr. 2017 Nov;190:222-228.e1. doi: 10.1016/j.jpeds.2017.06.046. Epub 2017 Aug 17.

  PMID: 28823554 DERIVED

MeSH Terms

Conditions

Osteoma, Osteoid

Condition Hierarchy (Ancestors)

Osteoma; Neoplasms, Bone Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Karun Sharma, MD, PhD

  Children's National Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 29, 2015
• Study Start: January 1, 2015
• Primary Completion: October 3, 2020
• Study Completion: October 3, 2020
• Last Updated: March 11, 2022

Record last verified: 2022-03

Locations

US (1)