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

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ClinicalTrials.gov Identifier: NCT02349971
Recruitment Status : Active, not recruiting
First Posted : January 29, 2015
Last Update Posted : April 2, 2019
Sponsor:
Information provided by (Responsible Party):
Karun Sharma MD, Children's Research Institute

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.

Condition or disease Intervention/treatment Phase
Osteoid Osteoma Device: MR-HIFU Not Applicable

Detailed Description:

Osteoid Osteoma (OO) is a benign, but painful, bone tumor commonly occurring in children and young adults. Common treatment options are surgical excision or, more recently, CT-guided radiofrequency ablation (RFA). RFA is less invasive, but it still requires drilling from the skin through muscle and soft tissue into bone. It also exposes the patient and operator to ionizing radiation.

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. MR-HIFU has been successfully used to treat painful bone metastases in adult clinical trials and one recent report suggests that it can also be used to treat OO.

MR-HIFU ablation of OO may provide a better alternative to surgical resection or RFA as it is completely non-invasive and does not require ionizing radiation. These two qualities of MR-HIFU are especially beneficial in growing children and young adults. Furthermore, MR-HIFU OO ablation is quick, with expected total procedure time of less than two hours. Such short treatments offer additional safety benefits from reduced anesthesia / sedation requirement compared to surgery and RFA


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Feasibility of MR-Guided High Intensity Focused Ultrasound (MR-HIFU) Ablation of Osteoid Osteoma in Children
Actual Study Start Date : January 2015
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Arm Intervention/treatment
Experimental: All Patients
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
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




Primary Outcome Measures :
  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. [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Response [ Time Frame: 12 months ]
    Provide an assessment of MR-HIFU ablation of OO in children by the number of patients who experience a measurable clinical and imaging response.



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Ages Eligible for Study:   up to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)
    • Normal PT, PTT and INR < 1.5 x ULN (including patients on prophylactic anticoagulation)
    • Renal function: Age-adjusted normal serum creatinine (table in protocol) OR a creatinine clearance ≥60 mL/min/1.73 m2 for safe contrast administration
  • Adequate pulmonary function: Defined as no dyspnea at rest, and a pulse oximetry >94% on room air if there is clinical indication for determination.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02349971


Locations
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United States, District of Columbia
Children's National Medical Center
Washington, District of Columbia, United States, 20012
Sponsors and Collaborators
Children's Research Institute
Investigators
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Principal Investigator: Karun Sharma, MD, PhD Children's Research Institute

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Karun Sharma MD, MD, Children's Research Institute
ClinicalTrials.gov Identifier: NCT02349971     History of Changes
Other Study ID Numbers: HIFU OO
First Posted: January 29, 2015    Key Record Dates
Last Update Posted: April 2, 2019
Last Verified: March 2019

Additional relevant MeSH terms:
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Osteoma
Osteoma, Osteoid
Neoplasms, Bone Tissue
Neoplasms, Connective Tissue
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms